Company Description AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on X , Facebook , Instagram , YouTube , LinkedIn and Tik Tok . Job Description More than a job - It's a chance to make a real difference Working at AbbVie is more than a job. It’s a career with meaning. A chance to make a difference, in the world and in your life. We are recruiting for a QA Compliance Specialist to join the team based in AbbVie Manorhamilton, Sligo. The QA Compliance Specialist is responsible for documenting and establishing a quality system which ensures full compliance with all regulatory and AbbVie requirements. The QA Compliance Specialist will have responsibility to assess and report on the effectiveness of the quality system to senior management. Key Responsibilities: Coordinating the quality system, ensuring full compliance by all personnel with its requirements. Coordination of Product Quality Reviews activities. Management of all Technical Agreements from initiation, review, approval and storage. Coordination and Management of all Track and Trend activities to support Manufacturing and QC. Driving a QRM approach to all activities on site. Coordination and facilitation of all Site RCS and FMEA activities. Auditing the quality system per the documented internal audit schedule. Assisting in the documentation, investigation of and coordinating customer complaints/exceptions by ensuring implementation of effective corrective / preventive action where necessary. Ensuring that products manufactured at Abbvie meet requirements of end users, of regulatory authorities and of the company. Measuring performance of the quality system and reporting on this at the management review meeting and during quality performance meetings. Coordinating change management, change control and Change planning activities. Monitoring quality performance and advising management personnel on major quality issues. Initiation and Completion of Quality related investigations and verification of the effectiveness of CAPA’s as required. Establishing Corrective / Preventive Action system and procedures. Management of the Supplier program including the ASL, Performance metrics and Audit Schedules Creation and approval of commodity specifications as required Performance of Vendor audits as required Supporting all aspects of inspection readiness including preparation activities, logistic activities, and generation of follow up responses and management of proof books. Adheres to and supports all EHS & E standards, procedures and policies Qualifications What you will need: A third level qualification in a science or quality discipline Minimum 3 years’ Experience in Pharmaceutical or Sterile Manufacturing environment Experience with internal and external auditing Strong written and verbal communication skills Additional Information AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html #J-18808-Ljbffr
Company Description AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on X , Facebook , Instagram , YouTube , LinkedIn and Tik Tok . Job Description Are you a strategic thinker with a passion for making a tangible impact? AbbVie Ireland is looking for a dynamic Director of External Engagement to enhance our presence in the region and take our strategies to the next level! About the Role: In this pivotal role, you'll lead efforts to align our commercial and manufacturing strategies with AbbVie's corporate vision. You'll be at the forefront of driving strategic projects, nurturing stakeholder relationships, and championing patient advocacy. Your collaboration across departments will ensure seamless communication and effective execution of vital initiatives. Reporting to the Ireland Commercial General Manager, your influence will be felt company-wide. Key Responsibilities: Strategic Leadership: Guide external engagement strategies, lead priority discussions, and offer insightful recommendations to the Ireland Board of Directors. Corporate Ambassadorship: Act as the face of AbbVie, ensuring comprehensive representation of our corporate interests. Project Management: Manage strategic projects that elevate AbbVie's footprint in Ireland, prioritised by senior leadership. Communication Strategy: Develop and implement internal and external communication strategies that promote AbbVie's brand. Patient Advocacy: Strengthen relationships with advocacy groups, integrating patient insights into our policies. Stakeholder Engagement: Cultivate and maintain robust relationships with key stakeholders, advocating for AbbVie’s interests. Qualifications What We’re Looking For: Educational Background: Bachelor’s/master’s degree in business, Communications, Public Affairs, or a related field. Experience: At least 10 years in external engagement, corporate strategy, or public affairs, especially in the pharma sector. Leadership & Collaboration: Proven track record in leading cross-functional teams and inspiring collaboration. Regulatory Acumen: Familiarity with navigating Ireland's regulatory and healthcare landscapes. Relationship Building: Demonstrated ability to build strong relationships with government, industry, and community leaders. Strategic Vision: Strong strategic thinking skills to align corporate goals within a matrix organisation. Communication Skills: Excellent ability to communicate complex information clearly and persuasively. Why AbbVie? Joining AbbVie means being part of an innovative and people-focused biopharmaceutical company where your skills and ideas can truly make a difference. If you're ready to lead the charge in shaping our external engagement in Ireland, apply today and help make possibilities real! Additional Information AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html #J-18808-Ljbffr
Company Description AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok. Job Description Please note that job level/grading my differ from country to country* Purpose Manage a team of Manufacturing Professionals responsible for Third Party Manufacture (TPM) contracts for Medical Devices or Combination Products. Assure that high quality products are manufactured in compliance with local and international regulations, and released and delivered according to the established forecasts, schedules, and cost planned. On going monitoring quality and delivery performance while minimizing risks associated with outsourcing production to a Third-Party Manufacturer. Responsibilities Lead a team of AbbVie TPM Account Managers to: Negotiate and manage Manufacturing Service Agreements (MSA), contract Amendments, and updates as needed, while ensuring compliance with the terms of the agreements. Asure global logistics are in place to support all phases of the manufacturing agreement in accordance with Purchasing and Supplier Quality expectations. Lead the development of ECM Device Financial Operating Plan, Updates, LRP, and Standard processes, and assure the financial goals are met. Monitor and control manufacturing costs to ensure efficient use of resources while maintaining product quality. Ensure timely communication with TPM in all aspects of the product agreement including product forecasts, manufacturing and delivery schedules. Identify, evaluate, and maintain strong relationships with third-party manufacturers to ensure quality production and timely delivery. Monitor manufacturing performance; apply OPEX (Operational Excellence) metrics as appropriate and ensure TPM manufacturing processes and standards align to deliver product in accordance with AbbVie quality & performance expectations. Assure in coordination with internal AbbVie functional partners that the TPM has the required quality systems and documentation to meet regulatory requirements, follow up inspection responses and commitments. Coordinate with PQA, the annual quality management review and periodic audits of the TPM. Assure deviations are properly investigated and product disposition decisions are made in a timely manner. Coordinate routine management reviews and provide on-going communication informing internal and TPM stakeholders of performance against expectations, highlighting issues, actions, and on-going improvements to increase performance at TPMs. Identifying and Selection of Third-Party Manufacturers (TPM); ensure team engagement on cross functional evaluation of new product needs and TPM’s due diligence initiatives. Identify, evaluate, and maintain strong relationships with third-party manufacturers to ensure quality production and timely delivery from onboarding, contract negotiations though renewals of the TPM. Identify potential disruptions like geopolitical instability, natural disasters, or labor issues and develop mitigation strategies. Ensure the manufacturer adheres to all relevant regulations regarding safety, environmental standards, and labor practices. Foster a collaborative partnership with TPMs to ensure mutual understanding and commitment to quality & performance. Lead a performance improvement culture & programs across TPMs; guide Account Managers to anticipate and act on ideas to increase efficiency and effectiveness. Establish and manage clear team expectations regarding roles & responsibilities, G&O’s while champion and model AbbVie’s performance and talent management practices. Develop and manage staff through hiring, managing performance, developing talent and providing clear expectations. Qualifications Qualifications Bachelor’s Degree required in a technical field: advanced technical degree (Master’s or Doctorate Degree) strongly preferred. 15+ years’ experience including: manufacturing of Medical or Electro-Mechanical Devices Strong technical and manufacturing assembly management experience Progressively increased responsibility and performance as supervisor, department manager and leader in Operations (Manufacturing, Quality, Engineering, etc..) Proven ability to inclusively manage and develop teams. Strong communication skills, ability to build trust and rapport, clear goal setting, fostering collaboration, promoting creativity, and adapting leadership style to suit the team's needs. Business acumen coupled with functional leadership experience is required to ensure effectiveness and high performance in a complex operation. Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. This job is eligible to participate in our short-term incentive programs. This job is eligible to participate in our long-term incentive programs Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html #J-18808-Ljbffr
Company Description AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok. Job Description The Qualified Person (QP) at AbbVie Biologics Ballytivnan Sligo is responsible for ensuring the compliance and quality of our pharmaceutical products. This role requires expertise in quality assurance practices within an FDA and EMEA approved environment to maintain product safety and integrity. As a QP for the site, you will work closely with our products throughout their manufacturing lifecycle, up until release from the site. Responsibilities Ensure compliance with EudraLex Volume 4 EU Guidelines for Good Manufacturing Practice and Annex 16 requirements. Certify that each batch is manufactured and checked according to relevant laws, GMPs, and product specifications at AbbVie Biologics Ballytivnan Sligo. Oversee the disposition of bulk products, determining release or rejection based on manufacturing and testing data. Assess and resolve day-to-day quality issues, ensuring products meet quality and safety standards. Support cross-functional teams in process improvement and cost efficiency initiatives. Provide technical leadership and collaborate with stakeholders to enhance product quality and process optimization. Make informed decisions within quality systems, adhering to regulatory standards, and handle quality queries from the operations team. Promote a culture of excellence in quality and compliance throughout the organization. Participate in internal and external audits, ensuring readiness and compliance with quality standards. Qualifications Essential: Bachelor's degree in a science discipline and a minimum of 5 years of experience in the pharmaceutical industry. MSc in Industrial Pharmaceutical Science or equivalent recognized for QP status under Directive 2001/83/EC, Article 49. Experience as a QP on a license preferrable Experience in aseptic processing and quality functions. Additional Information AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html #J-18808-Ljbffr
