External Site Quality Lead Api

Job Description: Our Quality Assurance group ensures all materials in our products are manufactured, processed, tested, packaged, stored, and distributed as aligned with our incredibly high standards of quality and meeting all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers, and suppliers, we create an interlinking global manufacturing network dedicated to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.

The Position of the External Site Quality Lead should possess a unique combination of analytical and scientific skills in order to effectively manage and control all activities necessary for support of a Quality Operations program governing manufacture, testing, packaging, storage, and distribution of API and API intermediates. The role receives guidance on policy issues and direction with regard to operations, but functions independently.

Core elements enabling success in the role include:

1. Assure that the Quality Operations department of the External Partner (EP) operates within established policies and procedures of the Division and Corporation and complies with all applicable governmental regulations, i.e. Good Manufacturing Practice (GMP), etc.
2. Through proactive input, ensure the development and maintenance of Quality Agreements with EPs.
3. Execute a program of calibrated quality oversight based on product type, capabilities, and quality and compliance performance of the EP.
4. Primary accountability in oversight of an EP may involve releasing API intermediates, API to other sites and/or to the market with the assurance that the goods were produced in conformance to all applicable policies and procedures of our company and compliance with all governing regulations.
5. Before shipment, ensure that products manufactured by the plant have the correct quality and identity, meet all pertinent specifications and special needs, and have been produced by approved processes and under proper conditions.
6. Be accountable for Quality assurance and control functions to include direct guidance to EPs, coordination and oversight for product testing, as well as other relevant components as established by applied calibrated quality oversight.
7. Be accountable for maintenance and oversight of ongoing supplier performance management to include regulatory inspection support and monitoring, internal complaint management, internal customer feedback coordination, and review of annual product reviews.
8. Review all audit outcomes pertaining to the EPs and ensure appropriate and timely corrective actions are identified and implemented.
9. Monitor efforts to improve EPs quality and reliability through ongoing oversight and formal communication programs and forums.
10. Provide guidance to EPs to facilitate and validate new product introductions.
11. Provide compliance input and guidance, as appropriate, for implementation of systematic methodology and process development initiatives.
12. In conjunction with other internal departments, ensure that EPs are inspection ready for all new product introductions or transfers.
13. Provide support and develop presentations for Quality Council meetings.
14. Provide oversight for presentation content and support issuance of minutes.
15. Assist in the coordination of significant investigations including Fact Findings and product recalls as needed.
16. Operate in a safe and efficient manner and in compliance with our Manufacturing Division Q.O. Safety and Health Policy.
17. Conduct quality due diligence assessments for pre-approval considerations of new EPs.
18. Partner with the EP in remediation of due diligence and pre-contract audit gaps.
19. Act as the Quality expert on the company’s behalf regarding contractual negotiations and provide input into the development of commercial contractual arrangements with the EP on quality related terms.
20. Partner with the regulatory compliance liaison on the company’s behalf to interface with regulatory agencies.
21. Closely partner with appropriate business and operations areas to achieve manufacturing division objectives.

Qualifications and Skills:

1. BA/BS Degree in Science, Engineering, or other relevant technical discipline, i.e. MS Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering, or equivalent.
2. Demonstrated success in the Pharmaceutical industry with a thorough knowledge of Quality Systems, Quality Assurance, and Quality Control, including solid knowledge of global GMP Quality Systems and regulatory requirements.
3. In-depth expertise in API manufacturing with a solid overview of external manufacturing preferred.
4. Strength of scientific skills in order to effectively manage and control all activities necessary to support a Quality Operations program governing external parties/partners that manufacture, package, analyze, release, store and/or distribute.