Manager Quality Operations

Provides Quality and Compliance oversight to Contract Manufacturing Organizations (CMOs) within a cross functional team and Product Disposition functionality for drug products manufactured by CMOs. Primary responsibility is to ensure that the CMOs are operating in compliance with all Bristol-Myers Squibb Co. and applicable FDA and international regulatory standards. In addition, this position has responsibility to ensure that released products comply with Bristol-Myers Squibb Co. internal and government (FDA or specific market) requirements and support Quality Systems processes (e.g., complaint investigations and change controls). This position will also be responsible for technical transfer of products from AstraZeneca to Patheon.

Education: B.S. in Natural Sciences, Chemistry, Microbiology, Biology, or Pharmacy

Experience: minimum of 7 years experience in pharmaceutical, biologics, biotech or related industry with relevant experience. Experience in a Quality Assurance or Quality Control function is required. Experience in the manufacture of drug substance and/or drug product or quality control laboratories is desired.

Travel: Willingness to travel up to 15-20% of the time across North America.

Skills:

Knowledge in solid dosage forms, parenteral technology, biologics or combination products. Knowledge of compendial and cGMP requirements, FDA regulations and the ability to interpret and apply them. Proficiency with the use of global systems (e.g., TrackWise, SAP). Good verbal and written communication skills essential. Excellent interpersonal skills. Capable to manage multiple priorities. Able to rapidly adapt to changing environment and a circumstances requiring flexibility, tolerance and great sense of urgency while ensuring that all cGMP and Regulatory requirement are met. Trained in auditing techniques and skills such as observation, questioning, and assessment of complex problems.

1. Manages CMO relationships from a quality and compliance perspective, including monitoring quality metrics, performing annual risk assessment of CMOs and executing oversight as defined by SOP, authoring and executing Compliance Improvement Plans as needed

2. Determines disposition of drug products according to BMS and regulatory specifications and standards

3. Review change requests generated internally or by External Manufacturer.

4.Reviews APQRs authored by Contract Manufacturers.

5.Investigate and/or evaluate manufacturing and laboratory deviations or incidents and associated CAPAs. Provide direction and recommendations as to future course(s) of action.

6. Review and approve Quality Agreements.

7. Approve product quality complaint investigations.

8. Review and approve validation/qualification protocols and reports from the External Manufacturer as defined in related Quality Agreements.

9. Write, review and implement SOPs to ensure compliance with current BMS standard and cGMP.

10.Serve on Market Action Fact Finding teams

11. Supports product recalls and executes plan as assigned.

12. Represent Bristol-Myers Squibb during FDA/other regulatory inspections and corporate GMP compliance audits as defined in related Quality Agreements.

13. Assist with preparation of audit observations.

14. Participate in audits (For Cause) of North American External Manufacturers of drug products ensuring compliance with all appropriate BMS and FDA and EMA agency cGMP regulations and policies.

15. Represent Quality on cross-functional teams within the "Virtual Manufacturing Plant", Technical Transfer teams, Supplier Selection, Serialization, and Manufacturing Launch teams.