External Site Quality Lead, EQA Devices &Combination Products Job - United Kingdom
- 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.
- The position corresponds to a team leader responsible for implementing company Quality Assurance policy and discharging Quality responsibilities for the oversight of contract manufacturing organizations that supply medical device components or combination products to the company.
- The responsibilities of this position may include the quality oversight of contract manufacture, testing, packaging, storage, and/or distribution of pharmaceutical products and medical device components; executed under the direction or on behalf of the External Quality Assurance Director.
- These activities include assuring that products are manufactured from approved processes in conformance to all applicable regulatory requirements and Company policies, and may include the release of manufactured products.
- The incumbent will exercise a leadership role in monitoring and maintaining contracted third party 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 Contract Manufactures through direct oversight, support and technical advice, counselling to the third party site senior leadership and providing on-site supervision as appropriate. This may include participation in activities such as third party selection, GMP Due Diligence, and establishing of Quality Agreements.
- The incumbent also provides support to build effective Quality Management Systems and drive continuous improvement activities at the Contract Manufacturer, in particular related to medical device component and/or combination product regulatory expectations; and maintains compliance with the Quality Agreements between the parties.
- The incumbent is expected to drive collaboration within internal and external cross-functional groups to achieve objectives, and communicate company expectations as necessary to improve relationship performance against agreed upon metrics and business goals.
Education Minimum Requirement:
B.Sc. Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering, or related disciplines, is required.
Required Experience and Skills:
- A minimum of five (10) years of experience working in the Pharmaceutical industry, with strong knowledge of and broad experience in Quality Assurance and Quality Control activities, particularly applied to drug delivery systems, medical devices and/or combination products.
- Experience in Quality Agreement development and cross-functional teamwork is required.
- Familiarity and experience in the application of ISO 13485 and ISO 14971 is also required.
Preferred Experience and Skills:
- Strong demonstrated communication skills. Prior experience managing 3rd Party relationships preferred.
- Demonstrated personal networking and relationship building skills.
- Conversant on domestic and foreign regulations and compendia governing manufacturing operations particularly applied to drug delivery system/medical device Quality Management Systems. Experience in Quality oversight of plastic molding operations or combination product manufacture preferred. Contractual and financial awareness is preferred.
- Experience in Lean project implementation also preferred.
- 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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