Overview Would you like to join an international team working to improve the future of healthcare? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. At Grifols, we believe that diversity adds value to our business, our teams, and our culture. We are committed to equal employment opportunities that foster an inclusive environment. Position The Associate Director, Pharmacology will be responsible for leading non‑clinical and early clinical pharmacology strategy across drug development programs. Provides expertise in PK/PD, modeling & simulation, and Model‑Informed Drug Development (MIDD) to support dose selection, study design, and regulatory submissions. Partners cross‑functionally with clinicians and statisticians, represents Pharmacology on global teams, and mentors junior scientists while ensuring scientific excellence and regulatory compliance. Responsibilities Lead PK/PD data analysis and modeling activities, applying mechanistic and population modeling approaches using tools such as Phoenix WinNonlin, NONMEM, and related platforms. Apply quantitative and statistical methods to support non‑clinical and early‑phase clinical pharmacology programs. Contribute to regulatory interactions and submissions, including INDs, BLAs, MAAs, Investigator’s Brochures, briefing packages, and responses to agency queries. Communicate complex clinical pharmacology concepts clearly and effectively to cross‑functional and external stakeholders. Provide scientific leadership in matrixed teams, driving pharmacology strategy, problem‑solving, and decision‑making across programs. Lead the analysis, integration, and reporting of clinical pharmacology data to inform dose selection and study design. Design and implement pharmacology plans and ensure best practices across project teams. Partner with clinicians and statisticians to optimise dosing strategies and clinical study designs. Oversee study‑level pharmacology activities, including protocol and SAP development, execution, and reporting. Drive the design and execution of Model‑Informed Drug Development (MIDD) strategies. Represent Pharmacology on global program teams, clinical sub teams, and other multifunctional groups. Mentor and coach junior colleagues and team members. Stay current with scientific literature, regulatory guidelines, and internal SOPs. Qualifications A doctoral degree (PhD) or equivalent professional training (PharmD), or post‑doctoral experience in clinical pharmacology, pharmacokinetics, pharmacology, toxicology, pharmaceutics, or a related scientific discipline. A minimum of 3+ years of relevant industry or academic experience supporting pharmacokinetic, pharmacodynamic, and broader pharmacology activities across non‑clinical and early clinical drug development programs. Hands‑on experience contributing to pharmacology strategy and execution within pharmaceutical or biotechnology environments, with the ability to apply scientific rigor in a fast‑paced, collaborative setting. Benefits A highly competitive salary package Group pension scheme - Contribution rates are (3%/ 5%/ 7%) and company will match Private medical insurance for the employee Ongoing career development opportunities within a rapidly growing organisation Strong focus on succession planning and internal promotion Dedicated education and professional development allowance Wellness and social initiatives, including activities such as padel and summer events Mostly remote working model, supporting work–life balance Location Grange Castle International Business Park, Grange, Co. Dublin, D22 K2R3 Learn more about Grifols #J-18808-Ljbffr
Grifols is seeking an Associate Director for Pharmacology in Dublin to lead non-clinical and early clinical pharmacology strategy for drug development. This role involves providing expertise in pharmacokinetics and modeling, overseeing pharmacology activities, and mentoring junior scientists. A PhD or equivalent training and 3+ years of experience in the pharmaceutical sector are required. The position offers a competitive salary, benefits, and a flexible remote work model. #J-18808-Ljbffr
Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well‑being of people around the world. We are leaders in plasma‑derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. At Grifols, we believe that diversity adds value to our business, our teams, and our culture. We are committed to equal employment opportunities that foster an inclusive environment. Position Summary The Associate Director of Translational Medicine bridges drug discovery (by application of preclinical studies) to clinical programs. The key roles of this position are to define translational strategies, manage external partners and ensure scientific rigor for decision making in drug development. The Associate Director of Translational Medicine focuses on biomarker discovery, assay development and clinical trial support by working closely with the discovery, pharmacology, clinical development and regulatory teams to advance therapeutic programs. What You Will Do Develop and implement scientific strategy of translational medicine studies, interpret data to support of program objectives. Discover, validate, and implement biomarkers to assess drug response, understand mechanism of action, and biomarker measures for animal and patient studies Prepare IND supporting documentation and participate in pre‑IND meetings with regulatory authorities. Defines and executes strategic plans for translational science projects that are aligned with regulatory expectations. Manage external partners like Contract Research Organizations (CROs) to ensure high quality and timely study execution. Initiate new areas of investigation and implement cutting‑edge technologies that are scientifically meaningful, reliable and can be incorporated directly into both preclinical and clinical development programs Present scientific findings internally and externally. Designs investigative translational strategies in support of research, preclinical and clinical development as well as regulatory strategies Leads the planning and implementation of experimental programs, with internal (Grifols) or external stakeholders, in support of asset readiness for clinical development phase Directs and coordinates experimental programs, with internal (Grifols) or external stakeholders, in support of asset readiness for clinical development phase Interprets, synthesizes and communicates preclinical and clinical biomarker study results to support key program decision making Provides scientific, technological and strategic guidance to biomarker and/or bioanalytical programs accompanying clinical trials in collaboration with nonclinical and clinical teams Contributes to the creation of study‑level documents, including review/ preparation of non‑clinical sections of key regulatory documents, such as protocols, Investigator’s Brochures, briefing meeting request & package and submission dossiers. May participate in due diligence assessments of potential external assets and participate and ISR evaluations May represent Grifols at external functions such as conferences May manage a team of scientists and research associates rives TM program evaluations within a multifunctional team and presents business opportunities the Senior Management. Works closely with Quality Management & Assurance to ensure work conducted by qualified vendors Assesses/implements departmental standardizations for new and improved practices and or consistent work practices, and SOPs Serve as a subject‑matter expert providing scientific guidance and support to project teams Provides translational teams leadership and develops teams with technical depth Contributes to developing and executing work in support of corporate goals Developing and managing vendor budgets What You’ll Bring Excellent knowledge of relevant diseases and biological processes Excellent and demonstrated project management skills. Excellent oral and written communication skills. Communicates complex technical and business information to technical and/or non‑technical audiences as well as upper management. Ability to interpret data, identify errors and provide corrective actions to procedures and processes to generate valid conclusions. Expertise in setting and meeting deadlines, multitasking, as well as identifying, requesting and prioritizing team resources based on project needs. Ability to anticipate future change and recommends strategies for optimizing processes and procedures that will mitigate long‑term foreseeable problems Demonstratable deep knowledge of related field principles, tools, and/or databases Adaptability to change in priorities Consistently motivated, even under difficult situations Excellent team player that creates an atmosphere for collaborative effort among the team Ability to articulate strategic options and scenarios to inform operational delivery of the project(s), understanding how to focus on the delivery of goals and contributes strategic insights to prioritization and decision‑making. Makes solid decisions based on a combination of analysis, experience and professional judgement. PhD or MS in Biology, Biochemistry, Immunology, Biological Engineering or related field. 5‑8 years of related experience. Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level requires a Bachelor’s degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate’s degree with 6 years of experience, or a Master’s degree with 2 years of experience. Our Benefits Include A highly competitive salary package Group pension scheme - Contribution rates are (3%/ 5%/ 7%) and company will match Private medical insurance for the employee Ongoing career development opportunities within a rapidly growing organisation Strong focus on succession planning and internal promotion Dedicated education and professional development allowance Wellness and social initiatives, including activities such as padel and summer events Mostly remote working model ( in Ireland) , supporting work–life balance Location: Grange Castle International Business Park, Grange, Co. Dublin, D22 K2R3 #J-18808-Ljbffr
Grifols is seeking an Associate Director of Translational Medicine in Dublin. You will bridge drug discovery to clinical programs by defining translational strategies and managing external partners. The role involves biomarker discovery, assay development, and contributing to IND documentation for regulatory meetings. The position offers a highly competitive salary, private medical insurance, and a mostly remote working model which supports work-life balance. #J-18808-Ljbffr
Grifols is seeking a Clinical Research Associate to assist in managing clinical trials in Dublin. The role involves ensuring compliance with regulatory requirements, overseeing vendor performance, and maintaining clinical trial documentation. Candidates should have at least 2 years of clinical research experience, including field monitoring, and an Associate’s degree in a life science. The position offers a competitive salary, benefits including private medical insurance, and opportunities for career development. #J-18808-Ljbffr
Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that has been working to improve the health and well‑being of people around the world since 1909. We are leaders in plasma‑derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. At Grifols, we believe that diversity adds value to our business, our teams, and our culture. We are committed to equal employment opportunities that foster an inclusive environment. POSITION SUMMARY Assist in the clinical trial management to ensure timelines and metrics are met and maintained throughout the study. Provide support in the oversight and management of vendors. Conduct a review of clinical data to ensure site adherence to applicable regulatory requirements, International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP) Guidelines, company standard operating procedures (SOPs), and study protocol. What You’ll Do Assist in the management of the clinical monitoring process to ensure site adherence to applicable regulatory requirements, ICH GCP Guidelines, company SOPs, and study protocols. Ensure timelines and metrics are met and maintained throughout the study. Have a good knowledge of the therapeutic area and product. Obtain a complete understanding of all trial‑related documents and operational procedures with moderate direct supervision. Audits/Inspections/Quality Assurance (QA) Support effective and timely audit/inspection responses. Clinical Trial Design/Performance Gain exposure/participate in case report form (CRF) development, interactive "X" recognition system (IXRS) set‑up, central laboratory set‑up, and other vendor selection processes and be capable of training others. Oversee completion of Pre‑Study Visits (PSVs), Site Initiation Visits (SIVs), Interim Monitoring Visits (IMVs), and Close‑Out Visits (COVs) to determine protocol and regulatory compliance. Contribute to the resolution of escalated issues from study centres, regulatory authorities and institutional review board (IRB)/independent ethics committees (IEC) with the support of the supervisor, if needed. Perform Sponsor Site Visits at selected sites to demonstrate oversight of the monitoring process and document the visits in the Sponsor Site Visit Report. Ensure timely execution of the clinical studies, generating quality data that ensure the well‑being of the study subjects and trial integrity with moderate supervision. With the support from the supervisor, may assist in the creation, review and tracking of study documents. May assist on the TMF reviews and resolution of findings, internally or interacting with the CRO with support if needed. Clinical Trial Materials (CTM) Provide support on the regulatory document review and approval for investigational product (IP) release. Provide support in clinical product technical complaints and product recall as necessary. Provide support and information to the CTM staff regarding IP management, as needed. In‑house Monitoring May assist with expedited identification, retrieval, and review of study documents particularly those required for site activation/start‑up. May facilitate investigator site payments, where applicable. Management/Training Team Facilitate meetings (e.g. Investigator Meetings, Kick‑off meetings). May provide support for monitor training and contribute to resolve issues identified. Collaborate to ensure that appropriate training is conducted for CRO staff, vendors, investigators, and study site staff on study requirements and internal SOPs. Monitoring Review and track comments of monitoring reports generated by the vendor (CRO) as part of Sponsor oversight of vendor clinical site monitoring activities. With the support of the supervisor, verify that study documents (e.g. case report forms, source documents, adverse events) are tracked and reviewed for completeness and accuracy to ensure data integrity. Track study‑specific tasks and progress of the trial. Maintain and update clinical trial management system (CTMS) information pertaining to the study. Oversight of vendor clinical monitoring activities, ensuring adherence to international ethical and scientific quality standards. Collaborate with data management to resolve queries. Vendor Management Assist in the management of vendor performance during conduct of the study with moderate direct supervision. Assist in evaluation of vendor performance during conduct of the study. Review/create/tracks trial newsletters, memos, mass correspondence, or other appropriate trial‑related documentation, with moderate supervision. Facilitate scheduling of internal team meetings, cooperating with defining the agenda and creating the meeting minutes, if needed. Additional On‑site Monitoring Responsibilities Perform monitoring/co‑monitoring activities for site initiation visits, interim site monitoring, and closeout visits in conformance with relevant laws, regulations, guidelines and internal SOPs/policies. Identify, screen, and qualify investigators through feasibility questionnaires and pre‑study visits. Reconcile clinical supplies and drug accountability records at study sites. Verify that study documents are tracked and reviewed for completeness and accuracy to ensure data integrity. Identify and effectively document site findings with an equal ability to re‑train, place corrective action, and follow‑up as required. Review, clarify, and obtain data changes via query resolution with site personnel. Conduct completion of PSVs, SIVs, IMVs, and COVs to determine protocol and regulatory compliance. Prepare telephone contact reports, confirmation letters, site visit reports, and follow‑up letters to accurately document site status and activities in agreement with the Clinical Monitoring Plan. Safety Understand and implement processes for distribution and tracking of SAE’s, safety documentation, and pregnancies. Monitor compliance of these processes. What You’ll Bring Typically requires 2 years of experience in clinical research, including a minimum of 1 year field monitoring experience (e.g. independent monitoring, co‑monitoring, accompanied site visits). Associate’s degree in a life science field required. Relevant experience in clinical research and field monitoring experience preferred (e.g. independent field monitoring and co‑monitoring). 4 years clinical research experience with 2 years experience as a CRA. Bachelor’s degree or higher degree in a life science field preferred. Our Benefits Include Highly competitive salary. Group pension scheme – contribution rates are (1.5% / 3% / 5% / 7%) and the company will match. Private medical insurance for the employee (Irish Life). Ongoing opportunities for career development in a rapidly expanding work environment. Succession planning and internal promotions. Education allowance. Wellness activities – social activities such as padel and summer events. Location: Grange Castle International Business Park, Grange, Co. Dublin, D22 K2R3. #J-18808-Ljbffr
Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. At Grifols, we believe that diversity adds value to our business, our teams, and our culture. We are committed to equal employment opportunities that foster an inclusive environment. POSITION SUMMARY The QA Manufacturing Analyst is required for a new purification and aseptic filling plant for the blood protein albumin at Grifols Worldwide Operations (GWWO). Reporting directly to the Quality Assurance Monitoring Supervisor of GWWO the role is for an experienced analyst who will perform aseptic sampling and environmental monitoring as part in the establishment of the Environmental Monitoring programme for aseptic manufacture and water systems for the manufacturing operations at GWWO. The successful candidate in this role will be required to work a 3-cycle shift in order to support manufacturing activities. 24/5 HOURS 7-7 Quality Assurance Activities Reviewing and support sampling plans for water systems. Routine sampling of Purified Water and Water for Injection. Assist and participate in qualification of clean rooms and sterilisation processes, aseptic gowning and other qualification processes where required. Lead and/participate in Environmental excursion investigations, deviations, CAPA and change controls and provide Quality support to the manufacturing area. Support the spot check/walk-through process of the lines. Support the annual product quality reviews if required. Training of new Quality personnel where appropriate. GMP implementation and site-wide Quality Awareness. Liaise with other Department representatives to promote improvements in GMP and Quality standards. Leading and implementing innovation, best practices and solutions for drug product manufacturing in collaboration with Quality teams from the Grifols sister sites. To support sampling plans for Media Fill and Process Validation batches. Liaise with Validation, Quality Control, Quality Manufacturing Assurance, Maintenance and the Operations team on execution of monitoring protocols. Provide quality performance information as required. Ensure regular Quality interaction with other Departments. To support any other additional activities as assigned by the QA manufacturing Monitoring Supervisor or the QA Manufacturing Manager Flexibility and willingness to carry out shift work PERSON SPECIFICATION Knowledge & Skills Excellent communication skills Self-motivated Good organizational skills Flexibility Cleanroom performing Environmental Monitoring within the aseptic pharmaceutical/medical devices industry. Deep knowledge and understanding of the aseptic regulatory requirements Grade C/D environmental monitoring experience. Possibility of Grade A/B environmental monitoring experience Qualifications Minimum of B.Sc Degree or equivalent third level education and at least 2 years’ experience working in an aseptic pharmaceutical/ medical devices industry. Our Benefits Include Highly competitive salary Group pension scheme - Contribution rates up to 7%. Private Medical Insurance for the employee Ongoing opportunities for career development in a rapidly expanding work environment Succession planning and internal promotions Education allowance Wellness activities - Social activities eg. Padel, Summer Events We understand that self-doubt can hold talented individuals back from applying for opportunities. We encourage everyone who meets the qualifications to apply – we're excited to hear from you Location: EMEA : Ireland : Dublin : Grange Castle (Dublin) #J-18808-Ljbffr
Overview Would you like to join an international team working to improve the future of healthcare? Grifols is a global healthcare company that develops, produces and markets innovative medicines, solutions and services in more than 110 countries and regions. We are committed to equal employment opportunities that foster an inclusive environment. The Cleaning Validation Engineer will represent the Validation team in leading validation projects and driving strategic initiatives. This role is responsible for planning and implementing Cleaning validation strategies for major capital projects and serving as the primary Validation representative in technical forums, including internal and external audits. Initial focus areas will include Equipment Qualification, Utilities, Process Validation, Aseptic Process Validation, and Cleaning Validation. What You'\u2019ll Do Write, review, and execute validation protocols and reports for Cleaning, Equipment, Steam Sterilisation, and Process Validation, ensuring compliance with global and site-specific quality and validation standards. Review change controls, assess the impact on validated systems, and define appropriate validation requirements. Represent the Validation function during internal and external regulatory inspections, including inspections by HPRA and FDA. Prepare and review project documentation, including User Requirement Specifications (URS), validation protocols, final reports, and Standard Operating Procedures (SOPs). Support validation activities through documentation review and hands-on execution to ensure equipment cleaning and processes meet current GMP requirements and industry standards. Maintain the Site Validation Master Plan (VMP) and associated project-level VMPs, defining validation strategies, requalification requirements, study scope, and frequency. Execute and coordinate re-validation activities as required. Complete risk assessments, manage deviations, and ensure timely closure of CAPAs. Independently resolve complex technical challenges, demonstrating strong problem-solving skills and the ability to adapt to changing priorities. Collaborate cross-functionally with Operations, Quality, Engineering, and Maintenance to lead qualification and validation activities supporting site projects. Review and analyse validation data to ensure scientific robustness, regulatory compliance, and data integrity. Perform additional validation-related duties as assigned by the Manager or Director. Act as an authorised signatory for validation documentation, with delegated authority from the Validation Manager, where appropriately qualified. What You'\u2019ll Bring A degree in Science, Engineering, or a related discipline, or a minimum of 5 years’ experience in a Validation role within the pharmaceutical or regulated manufacturing sector. Proven project management experience, with the ability to plan, coordinate, and execute validation activities across multiple workstreams. Hands-on experience executing Cleaning, Process, Aseptic Process, and Software Validation within a GMP manufacturing environment. Demonstrated experience working in a Quality or Validation function within the pharmaceutical industry. Strong technical writing and analytical skills, with experience authoring and reviewing validation documentation and reports. Solid knowledge of current Good Manufacturing Practices (cGMPs) and relevant industry, regulatory, and federal guidelines. Experience representing organisations during internal (corporate) audits and external regulatory inspections, including FDA and HPRA. Working knowledge of HTM 01 (Part C – Steam Sterilisation), including autoclave systems. Familiarity with ISO 14644 (Cleanrooms and Associated Environments). Strong understanding of EU GMP Annex 1 (Manufacture of Sterile Medicinal Products). Experience working within an aseptic manufacturing environment. Proficiency with Microsoft Word, Excel, and Access. Strong interpersonal and communication skills, enabling effective collaboration with Operations, Quality, Engineering, and Maintenance teams. Our Benefits Include A highly competitive salary Group pension scheme with contribution options of 1.5%, 3%, 5% or 7%, with company matching Private medical insurance for the employee Ongoing opportunities for career development within a rapidly expanding organization Strong focus on succession planning and internal promotion Education and professional development allowance Wellness and social initiatives, including activities such as padel and summer events Location: Grange Castle International Business Park, Grange, Co. Dublin, D22 K2R3 Learn more about Grifols #J-18808-Ljbffr
Grifols is seeking a QA Manufacturing Analyst for their new purification and aseptic filling plant in Dublin. The successful candidate will perform aseptic sampling and environmental monitoring as part of the Quality Assurance team. A minimum B.Sc Degree and at least two years of experience in aseptic pharmaceutical or medical devices is required. The role involves flexible shift work and supports the establishment of the Environmental Monitoring programme. Benefits include a competitive salary and private medical insurance. #J-18808-Ljbffr
Grifols is a global healthcare company focused on improving the health and well-being of people around the world, with leadership in plasma-derived medicines and transfusion medicine and operations in more than 110 countries and regions. Overview Position: HR Business Partner (HRBP). The HRBP partners with business leaders and key stakeholders to proactively support organisational goals and people strategy. The role acts as a trusted advisor for effective people practices, delivers strategic and operational HR support, coaches line managers, leads or contributes to HR initiatives, and uses data-driven insights to enhance engagement, performance, retention, and organisational effectiveness. Responsibilities Build and maintain strong, collaborative relationships with key stakeholders across the business and corporate functions, enabling cross-functional HR partnership. Contribute to the development and execution of the HR strategy to align with business objectives and culture, in partnership with the Senior HR Manager. Coach and support line managers to strengthen leadership capability, people management effectiveness, and performance outcomes. Partner with external vendors and benefits providers to support HR programmes and enhance the employee experience. Lead and participate in strategic HR projects and initiatives, including diversity and inclusion, employer branding, and HR programme implementation. Act as a champion for organisational change, supporting delivery of local and global HR initiatives. Lead and/or support talent strategies, including design and rollout of management and leadership development programmes, and support for training grant administration where applicable. Provide accurate payroll-related information to the payroll team, support payroll data validation, and ensure appropriate approvals and documentation are in place. Support HR operations by ensuring data integrity and effective management of the employee lifecycle and records. Develop and implement initiatives to improve employee engagement, satisfaction, and retention; analyse feedback and data to identify trends and action plans. Support leaders in embedding engagement initiatives and tracking progress and outcomes. Advise employees and managers on performance management, conflict resolution, disciplinary processes, and grievance matters; manage employee relations in a compliant manner. Maintain up-to-date knowledge of relevant employment legislation; lead policy and procedural updates as required. Use HR data and analytics to assess trends, identify opportunities, and make data-driven recommendations; prepare regular reports for senior management and monthly business reviews; track HR KPIs aligned to corporate strategy. Maintain knowledge of Quality and Regulatory Compliance within a pharmaceutical environment; participate in site quality activities as required. Qualifications & Experience Proven experience (3–4 years) in an HR Business Partner, HR Generalist, or similar role, supporting leaders across multiple HR disciplines. Strong stakeholder management skills with the ability to influence and build credibility at all levels. Experience coaching managers and supporting organisational change and people initiatives. Solid working knowledge of employee relations, performance management, and employment legislation. Experience using HR metrics and data to generate insights and support decision-making. Strong organisational skills with the ability to manage multiple priorities, maintain confidentiality, and deliver with attention to detail. Excellent written and verbal communication skills with a collaborative, solution-focused mindset. Bachelor’s degree or equivalent qualification in HR, Business, or a related discipline; professional HR accreditation (e.g., CIPD or local equivalent) preferred. Experience in a regulated environment (pharmaceutical or medical devices) and familiarity with quality systems is an advantage. Benefits A highly competitive salary package Group pension scheme with company matching Private medical insurance for the employee Ongoing career development opportunities within a rapidly growing organisation Strong focus on succession planning and internal promotion Education and professional development allowance Wellness and social initiatives, including activities such as padel and summer events Hybrid working model (in Ireland), supporting work–life balance Location Grange Castle International Business Park, Grange, Co. Dublin, D22 K2R3 #J-18808-Ljbffr
