Want to make a global impact? We offer that.
Want to be part of a Great Place to Work in Ireland? We offer that too.
Welcome to AbbVie!
We are a global, research-based biopharmaceutical company that combines the focus and passion of leading-edge biotech with the expertise and capability of an established pharmaceutical leader. Redefining what is possible is our business and our passion. Our goal is to help patients live healthier lives and we are proud to be a Great Place to Work.
We are now recruiting a Third-Party Quality Manager, to join our diverse Quality team in Clonshaugh, Dublin. The Third-Party Quality Manager is responsible with management support for the development and implementation of Quality Management Systems to support ongoing and enhanced oversight of Contract Organizations (CMO’s) involved in the manufacture, testing and release of products within the oversight portfolio of 3rd Party Products & Active Pharmaceutical Ingredients (API's), starter materials and excipients. This role will have a direct report, and will report into the Director of Third-Party Quality – International
Are you intrigued? Do want to learn more?
A snapshot of your key responsibilities as Third-Party Quality Manager would be:
- Responsible for day-to-day activities designed to maintain and enhance the local Quality Management System for 3rd Party Quality oversight in line with directive 91/356/EEC, as amended by Directive 2003/94/EC, FMD including Article 52(a) of Directive 2001/83/EC, ICH Q7, EudraLex Volume 4, ISO13485 as applicable
- Primary responsibility for API, starter materials and excipients procured and owned by AbbVie and support for Third Party finished products. Providing QA oversight of quality systems operating at CMO's and internal/external supply chain operations. Maintenance of the Active Substance Register (ASR).
- Contribute and guide completion of milestones associated with specific projects in support of API, starter material and excipient oversight ensuring that robust and compliant systems are in place and supporting continuous quality system improvements
- Actively involved in the review, monitoring, reporting of quality systems trends by participating in the review and approval of annual product quality reviews, complaints, deviation, change controls etc, as they relate to APIs, starter materials and excipients as well as assuring that the appropriate documentation is in place as per cGMP guidelines and AbbVie’s Corporate Quality Management System.
- Performs timely review of documentation/investigations/reports highlighting and assisting in the resolution of issues commensurate with the level of risk. Review of CoAs, CoCs, testing, stability, annual product reviews, validations, change controls and master documentation. Provide guidance and support to clients in defining QA needs for new and existing systems based on regulatory agency requirements and business objectives.
- The Third-Party Quality Manager will be involved in the preparation, support and follow-up of Regulatory Agency inspections including FDA, HPRA, TUV Regulatory Agencies, Corporate & Strategic Partners as well as performing internal audits as required.
- The Third-Party Quality Manager is expected to adhere to all cGMP compliance and regulatory mandates and quality requirements and comply with all SOPs and internal policies and procedures in the performance of job duties.
- Support the generation and routine update of technical quality agreements with affiliate and CMO organizations as required for API's, starter materials and Excipients to support existing licenses and authorizations.
- Support the maintenance and development of a risk-based oversight model for API's, starter materials and excipients in line with AbbVie's corporate management system
- Ensure that the appropriate SOPs are in place and in line with Corporate Quality Standards. Ensure cGMP documentation compliance, such as Standard Operating Procedures, investigations, reports are reflective of current state. Participation in preparatory activities for competent authority and corporate inspections
- Interface between Regulatory Affairs, Science & Technology, R&D and other relevant departments where necessary e.g. validation activities, tech transfers.
- Bachelor's Degree required. Chemistry or Life Science degree preferred. Some exceptions made for those candidates demonstrating equivalent knowledge and having pharmaceutical experience.
- Minimum of 5+ years' experience in QA/Compliance in pharmaceuticals or related industry,
- Detailed knowledge of cGMP requirements and industry best /current regulatory expectations.
- Strong analytical skills and knowledge of quality systems.
- Demonstrated written and verbal communication skills.
- Ability to provide project leadership and guide successful completion of quality projects.
So, does this all sound like the right role for you? Then come join AbbVie!
AbbVie is an Equal Employment Opportunity Employer; we value bringing together individuals from diverse backgrounds to develop innovative solutions for patients and being part of an inclusive work environment.
Travel: Yes, 10 % of the Time
Job Type: Experienced