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Ready to join the AbbVie Team?
The complexities of our global organisation provide unique opportunities for growth, job stability, and the pursuit of what matters most to us in our lives. Our passion for operational excellence helps us have a remarkable impact on lives worldwide while maintaining a strong work/life balance that keeps us focused and fulfilled.
We are now recruiting for Associate Director of Product Quality to join our team in Clonshaugh, Dublin. The Associate Director for Product Quality is responsible for systems and processes associated with finished product including product release and post manufacturing Quality. This position interfaces and collaborates with corporate and other site management in assuring that the company team is fully compliant with HPRA, FDA and corporate standards and is also eligible to act as a QP (Qualified Person). The Associate Director of Product Quality will have the responsibility of supervising a team of QPs, QA Specialists and QA Technicians and will report into the site Quality Director.
So, if you are ambitious and driven to make a real impact on a global scale, read on to find out more and apply….
Primary duties and responsibilities of the position are as follows:
- Provide strategic and tactical direction for the QA Post-Production Quality Systems design and maintenance while managing key site quality systems such as Non-Conformances, CAPA, Complaints and Product Quality Reviews.
- Assist the QA Compliance group as appropriate for Internal Auditing, Technical Agreements and Site Master File maintenance.
- Ensure site compliance with HPRA, U.S. Food and Drug Administration and other regulatory authority regulations, as appropriate while supporting a culture of constant site readiness for site inspections
- Support daily activities, ensuring QA personnel execute their work in strict accordance with SOPs, and cGMP guidelines while also serving as a key participant in site regulatory inspections and SLA (Service Level Agreements).
- Seek process innovation and continuous process improvement in QA function and provide direction to ensure that specified targets for team are met.
- Maintain accountability for own team’s performance metrics ensuring data reports on team’s performance are current, accurate, and distributed according to defined procedures.
- Establish a supportive environment, to ensure that staff has the capability to meet performance expectations by providing hands on training, support, and coaching to reports.
- Contribute to the continual improvement of QA documentation and ensure that they are current, accurate, and clearly define process and role responsibilities.
- Always maintain a knowledge of the Role and Responsibilities of the Qualified Person, for example, familiarisation with literature such as ECA Good Practice Guide for Qualified Persons within the EU.
- Ensure each batch certified and its manufacture complies with the provisions of the marketing authorisation including the authorisation required for importation of IMP’s where relevant). Ensure all necessary checks and tests are adequate and performed correctly.
- Maintain a register (or equivalent document, i.e. SAP) as a record of product batches certified by the QP prior to release.
- Prepare and conduct performance appraisals in accordance with Company guidelines while leading department initiatives and projects
Education and Experience:
- Bachelor’s Degree or above in Chemistry, Pharmacy or related Science and or post graduate qualification in Pharmaceutical Manufacturing Technology which ensures the eligibility requirements for acting as a Qualified Person as defined in directive 2001/83/EC of the European Parliament.
- At least 10 years relevant Pharmaceutical Quality experience and 3-5 years supervisory experience. This experience does not have to be limited to Quality Assurance.
- Demonstrated success in managing a team in a pharmaceutical production environment and providing leadership in a technical environment
- Experienced and knowledgeable in EU and FDA cGMPs
- Experienced in interacting with regulatory authority inspectors
- Experience in managing by metrics
- Experienced in aligning individuals and teams to business objectives
- Exposure to Lean manufacturing concepts
Travel: Yes, 5 % of the Time
Job Type: Experienced