Director External Site Quality Lead Job - Ireland
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- Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products.
- Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.
- Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you.
- To this end, we strive to create an environment of mutual respect, encouragement and teamwork.
- As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
- Individual contributor 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 sterile pharmaceutical products, API intermediates, API, non-sterile pharmaceutical products, biologic, drug delivery devices and consumer care products under the direction or on behalf of the Quality Operations Director or Executive Director.
- 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.
- The incumbent ensures 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.
- This includes overseeing 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.
- This includes participating 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.
- BS Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering (or equivalent) preferred.
- Minimum of 10 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.
- Our employees are the key to our company’s success.
- We demonstrate our commitment to our employees by offering a competitive and valuable rewards program.
- Our Company’s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives.
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