A project management firm based in Cork is seeking a Marketing and Administration Coordinator to provide high-level support. Responsibilities include content development, social media management, and administration of training programs. Candidates should possess a degree in Marketing or Business Administration and have experience with WordPress and Microsoft Office. Strong written and verbal communication skills, along with the ability to multitask in a busy environment, are essential for this role. #J-18808-Ljbffr
A biopharmaceutical company in Waterford is seeking a Regulatory Site Officer to ensure compliance with regulatory standards for products. Responsibilities include managing regulatory submissions, reviewing quality documentation, and participating in audits. Essential qualifications include a degree in Science or Pharmacy and over 2 years of relevant experience in Regulatory Affairs. The candidate will track regulatory activities in real time and support various quality management tasks, contributing to overall product integrity. #J-18808-Ljbffr
A Regulatory Site Officer is required for a biopharmaceutical company in Waterford. The successful candidate will join the team responsible for managing products manufactured onsite from a regulatory perspective; ensuring submissions are submitted on time, assessing change controls and deviations and ensuring regulatory compliance. Responsibilities Maintenance of, and variations to, CMC Dossier for assigned products. Support and manage all regulatory requests impacting site products including coordination of site expert responses to support GRA in conclusion of request for information (RFI) activities as a result of deficiency letters (DLs) received from respective Health Authorities (HAs). Assess the regulatory impact of proposed changes by site for assigned products. Review and approval of Quality documentation including (but not limited to): batch records; specifications; plans; protocols/ technical reports; Standard Operating Procedures (SOPs), deviation assessments, and failure investigations for assigned products, as appropriate. Second RSO review for submission documentation. Track all site regulatory activities in real time within the site planning tracking tools. Monitor submission/approval status and track updates for assigned products. Participate in regulatory inspections/audits. Initial BLA/MAA authoring/coordination, as appropriate. Product Registration Renewals. Annual Reports e.g. US, Canada, Brazil. Periodic Quality Reviews (PQR). Contribute in project teams and provide regulatory guidance/ support. Takes ownership of product-related meetings i.e. core meeting on site/meeting with GRA/RSO counterparts in sister sites. Regulatory or Dossier Compliance. Creation and maintenance of Overarching and Batch specific MARs/MCAs. Legalisations and notarisation requests. Preparation of Site Master File (SMF). Maintenance of local site accreditations e.g. investigational manufacturing license (IMP), manufacturing license and GMP certification. Site Registrations & Renewals e.g. Foreign Manufacturing Registration (FMR). Distribution of approval notification to site. Document review (Veeva Vault). Ensure Quality tasks are completed in timely manner. Qualifications & Experience Degree in Science, Pharmacy or related discipline is essential. 2 years+ relevant experience. Experience of Regulatory Affairs, Manufacturing and/or Quality Operations, dealing with Health Authorities and working through corporate structure is desirable. #J-18808-Ljbffr
A biopharmaceutical company in Waterford seeks a Project Portfolio Lead to oversee project delivery and manage cross-functional teams. The successful candidate will translate business needs into project scope, drive execution, and ensure compliance with industry standards. Responsibilities include managing stakeholder relationships, change control processes, and project risk management. A degree in Science or Engineering and experience in project management within the biopharma industry are required. This role involves working closely with various teams to facilitate project success. #J-18808-Ljbffr
A leading pharmaceutical manufacturing company located in East Cork seeks an experienced Project Scheduler to join their Capital Projects team. The successful candidate will manage and maintain project schedules, collaborating with cross‑functional teams to support project delivery. Qualifications include a degree in Engineering or Project Management, and 3–7 years of experience in project scheduling, preferably within regulated environments. Proficiency in Primavera P6 and Microsoft Project is essential. This role is crucial for ensuring timely project execution and alignment with objectives. #J-18808-Ljbffr
Summary We currently have an opportunity for a Marketing and Administration Coordinator to join our Cork office. The incumbent will provide a high level of marketing and administration support to the office. Responsibilities Provide input into content development and graphic design. Carry out website updates and maintenance. Maintain the marketing calendar, research and updates. Post on social media platforms, obtaining statistics from posts. Newsletter coordination and development, maintenance of subscribers list and templates. Supporting Training and Development administration for company personnel involving the maintenance of training folders and registers with copies of relevant qualifications and training certs. Administer CPD function to ensure compliance with Engineers’ Ireland ‘Accredited CPD Employer’ status for Tandem. Help prepare training plans for staff and organise specific training as required and book approved training modules. Pursue opportunities to obtain grants applicable for training. Administration for the Advance Graduate Programme and undergraduate work placements and Transition Year Programmes. Participation in Tandem’s Corporate Social Engagement and Thrive EHS & Wellbeing committees. Research into speakers for Lunch & Learn events. Liaise with Engineers Ireland STEPS programme. Qualifications & Experience Marketing or Business Administration degree or similar discipline required. A qualification in Digital marketing is a distinct advantage. Experience with WordPress, Canva, Adobe, social media analytics and Mailchimp is beneficial. Proficiency in Microsoft Office (Word, Excel and PowerPoint, Outlook) is essential. Ability to multitask in a busy environment is a prerequisite for this position. Strong written and verbal communication skills. #J-18808-Ljbffr
Summary A Project Portfolio Lead is required for a biopharmaceutical company in Waterford. The successful candidate will join a team responsible for overseeing and delivering projects across the site. Responsibilities Lead cross-functional, multi-site teams in the introduction and business integration of Dupixent DS. Translate customer and business needs into defined, approved project scope statements. Work with functional managers to quantify resource requirements across the cluster. Establish detailed project plans and drive execution of project tasks in line with agreed scope, schedule, and cost. Run regular project meetings to lead and influence the project, adhere to scope, and ensure timely completion according to schedule; establish and execute a communication plan and facilitate information flow between stakeholders and sites. Drive project risk identification, analysis, response, and implement & monitor mitigations to minimise impact to the project or wider business Facilitate cost estimation to determine project budgets and drive adherence to budget and forecast submission. Project Stakeholder Management — analyse stakeholder expectations and their impact on the project, and develop appropriate management strategies for effectively engaging stakeholders in project decisions and execution Raise, author, and manage change controls in accordance with Sanofi’s Quality Management System (QMS) and site SOPs. Coordinate and track the execution of change control tasks across cross-functional teams, ensuring timely completion of all actions. Manage change control workflows ensuring compliance with GMP and regulatory requirements. Conduct post-implementation reviews to confirm changes have been effectively executed and documented. The Project Portfolio Lead is responsible for GMP documents in line with Waterford site procedures; therefore, training to Waterford GMP systems is required. Qualifications & Experience Degree in Science, Engineering or equivalent. Experience in the biopharma industry, in a project leadership role. Demonstrated experience in project/program management in drug substance or drug product. Demonstrated experience in change control management within a GMP-regulated environment. Working knowledge of cGMPs, GLP, etc. #J-18808-Ljbffr
A biopharmaceutical company in Carlow is seeking a QA Specialist to provide quality oversight for the introduction of new products. The role involves managing QA activities, reviewing documentation, and ensuring supplier performance metrics are met. Candidates should have a relevant degree and 3-5 years of experience in a quality role within a pharmaceutical manufacturing environment. Familiarity with cGMP, Lean Six Sigma, and regulatory requirements is preferred for successful oversight and compliance. #J-18808-Ljbffr
Summary Our client, a leading pharmaceutical manufacturing company based in East Cork, is seeking an experienced Project Scheduler to join their Capital Projects team. The successful candidate will be responsible for developing, maintaining, and managing project schedules across a portfolio of capital projects. This role will support project delivery by providing clear visibility on timelines, risks, and progress, working closely with cross‑functional teams to ensure alignment with project objectives and timelines. Responsibilities Develop, maintain, and update detailed project schedules using Primavera P6 and Microsoft Project. Work closely with Project Managers, Project Controllers, and cross‑functional teams, including Engineering, Procurement, and Construction to define project scope, milestones, and deliverables. Support baseline schedule development, progress tracking, and forecasting activities across multiple projects. Monitor critical paths, identify potential delays, and provide early warning along with recovery plans. Manage and incorporate change events into project schedules, including scenario planning to assess potential impacts. Support resource planning and levelling across concurrent projects. Generate regular progress and performance reports, including milestone tracking, variance analysis, and schedule performance metrics. Participate in project review meetings and contribute to status reporting and schedule risk assessments. Ensure all schedules are developed and maintained in line with internal procedures and regulatory expectations. Collaborate with cost control teams to integrate cost and schedule data for reporting and project tracking. Contribute to the continuous improvement of scheduling processes and project controls practices. Qualifications & Experience Degree in Engineering, Project Management, or a related discipline. Minimum 3–7 years’ experience in project planning or scheduling, ideally within pharmaceutical, biopharmaceutical, or related regulated environments. Strong experience using Primavera P6 and Microsoft Project for complex project scheduling. Good understanding of project lifecycles, including engineering, construction, and commissioning activities. Experience in resource loading, progress measurement, and schedule risk analysis. Strong communication skills with the ability to work effectively across cross‑functional teams. High attention to detail with strong analytical and organisational skills. Experience with project controls tools and reporting systems (e.g. Excel, Power BI). Ability to manage multiple priorities in a fast‑paced project environment. #J-18808-Ljbffr
Summary A QA Specialist is required for a biopharmaceutical company in Carlow. The successful candidate will provide quality oversight and direction for the introduction of new products and materials, as well as manage external parties. Responsibilities Provide QA oversight to support Analytical, Warehouse and Facilities Management, including deviations, root cause analysis, CAPAs and change controls. Participate as a functional expert in the cross‑functional team responsible for introducing products and materials. Review documentation associated with new product and material introduction, such as material packs, QC test specifications, BOMs, supplier qualification and oversight. Develop and monitor supplier performance metrics, participate in material review boards and quarterly reviews of key suppliers, and actively engage in cross‑functional forums as needed. Maintain the approved supplier management list within the qualified supplier management system, ensuring correct setup of suppliers and materials used on site. Support deviation and atypical closeout, as well as initiate and follow up on corrective and preventive actions. Author, review, and approve protocols and reports for technology transfer, method qualification, and method validation. Conduct quality reviews and approvals of engineering, validation, automation, utilities commissioning and qualification activities. Serve as the point of contact for quality at both the site level and with external inputs, coordinating and attending quality working group meetings. Facilitate compliance direction for the site by adhering to divisional policies, guidelines, and regulatory requirements. Proactively evaluate site compliance against emerging trends and initiate major compliance initiatives for improved status and operational efficiency. Actively participate in plant/quality committees and collaborate with other site functional groups. Qualifications & Experience Relevant degree. A minimum of 3‑5 years of experience in a quality role, ideally in a pharmaceutical manufacturing environment. Knowledge of regulatory/code requirements related to Irish, European, and international codes, standards, and practices. Familiarity with cGMP (current Good Manufacturing Practice) and GDP (Good Distribution Practice) is preferred. Strong report, standards, and policy writing skills. Experience with equipment and process validation. Familiarity with sterile filling processes and equipment. Proficiency in Microsoft Office and job‑related computer applications. Experience or familiarity with Lean Six Sigma methodology is desired. #J-18808-Ljbffr
