Quality Manager - External Manufacturing
A Quality Manager - External Manufacturing is required by CareerWise Recruitment for our Cork based biotech client.
ROLE OF THIS POSITION
- You will be responsible to implement Quality Operations (Quality Assurance and Quality Control) policy and discharge all QO responsibilities supporting external parties/partners and alliances (EP’s) for manufacture, testing, packaging, storage, and distribution of pharmaceutical products,
- These activities include assuring that products are produced from approved processes in conformance to all applicable regulatory requirements and Company policies and may include the release of all manufactured products.
- The incumbent will exercise a leadership role in monitoring and maintaining the EP’s compliance with the FDC Act, current Good Manufacturing Practices Regulations (domestic and foreign), and other pertinent legal requirements.
- You will ensure the quality performance of EP’s through direct oversight, support and technical advice, counselling to the EP site senior leadership and providing on-site supervision as appropriate.
- You will oversee activities such as EP selection, GMP Due Diligence, and establishing Quality Agreements. The incumbent also provides support to build effective quality systems and drive continuous improvement activities at the EP.
- You will participate in end to end risk management and strategic initiatives related to compliant supply, operationalizing quality and developing an engaged and capable workforce within the extended external manufacturing organization.
- This role will involve about 15% travel
- B.Sc. in Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering (or equivalent) preferred.
- Minimum of 7 years’ experience in the pharmaceutical industry with a thorough knowledge of Quality Systems, Quality Assurance and Quality Control including solid knowledge of global GMP and regulatory requirements.
- Competent in analyzing complex product, production and testing issues and have demonstrated scientific problem solving capabilities.
- Possess strong compliance mindset, demonstrated interpersonal skills, including leadership and coaching, motivation, communication and negotiation.
- Some level of contractual and financial awareness is required
For further information please contact Brian Flynn (Executive Search) for more information or to apply - click APPLY.