Quality Operations Manager

New Brunswick, NJ, United States
Sep 29, 2020
Required Education
Bachelors Degree
Position Type
Full time
Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

Manager Quality Operations ExM Americas

Quality Operations External Manufacturing - Americas
Job Function

Provides Quality and Compliance oversight to Contract Manufacturing and Packaging 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 Services processes (e.g., complaint investigations and change controls).

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 Risk Mitigation 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/Packagers and supplement APQR as required.

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

6. Review Quality Agreements.

7. Review and 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.Participate as required on Fact Finding Investigation Team (FIT and Fact Finding Investigation Review Meetings (FIRM)

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 oberservations.

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 Manufacturing and Packaging launch teams.
Designee Responsibilities
This position can be a designee for Associate Director Quality Operations ExM Americas or Senior Manager

Contingency support

In the absence of the Manager Quality Operations ExM Americas a comparable manager can act as a designee.
Required Competencies

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., SAP, DCA). Good verbal and written communication skills essential. Excellent interpersonal skills. Capable to manage multiple priorities. Able to rapidly adapt to changing environment and 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.

Required Qualification(s) and Desired Experience

B.S. in Natural Sciences, Chemistry, Microbiology, Biology, Engineering, Pharmacy or equivalent A minimum of 5 years experience in pharmaceutical, biologics, biotech or related industry with relevant experience. Experience in a Quality Assurance, Quality Control or equivalent function is required. Experience in the manufacture of drug substance and/or drug product or quality control laboratories is desired.

Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.