Manager, Quality Operations, External Manufacturing

2 weeks ago

New Brunswick, United States Bristol-Myers Squibb Full time

**Working with Us**
Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.

**Position Summary**

The Manager of Quality Operations will provide 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. The primary responsibility of this role is to ensure that the CMOs are operating in compliance with all Bristol Myers Squibb (BMS), applicable Food and Drug Administration (FDA), and international regulatory standards. In addition, this position has responsibility to ensure that released products comply with BMS internal and government (FDA or specific market) requirements and support Quality Services processes (e.g., complaint investigations and change controls).

**Key Responsibilities**:

- 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 Standard Operating Procedures (SOP's), authoring and executing Risk Mitigation Plans as needed
- Determines disposition of drug products according to BMS and regulatory specifications and standards
- Review change requests generated internally or by External Manufacturer
- Reviews Annual Product Quality Reviews (APQR's) authored by Contract Manufacturers/Packagers and supplement APQR's as required
- Investigate and/or evaluate manufacturing, packaging and laboratory deviations or incidents and associated Corrective and Preventive Actions (CAPA's) and provide direction and recommendations as to future course(s) of action
- Review Quality Agreements
- Review and approve product quality complaint investigations
- Review and approve validation/qualification protocols and reports from the External Manufacturer as defined in related Quality Agreements
- Write, review and implement SOP's to ensure compliance with current BMS standard and current Good Manufacturing Practices (cGMP)
- Participate as required on Fact Finding Investigation Team (FIT and Fact Finding Investigation Review Meetings (FIRM)
- Supports product recalls and executes plan as assigned
- Represent Bristol Myers Squibb during FDA/other regulatory inspections and corporate Good Manufacturing Practices (GMP) compliance audits as defined in related Quality Agreements
- Assist with preparation of audit observations
- Participate in audits (For Cause) of North American External Manufacturers of drug products ensuring compliance with all appropriate BMS and FDA and European Medicines Agency (EMA) cGMP regulations and policies
- Represent Quality on cross-functional teams within the "Virtual Manufacturing Plant", Technical Transfer teams, Supplier Selection, Serialization Manufacturing and Packaging launch teams

**Key Requirements**:

- B.S. in Natural Sciences, Chemistry, Microbiology, Biology, Engineering, Pharmacy or equivalent
- A minimum of five (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
- Knowledge in solid dosage forms, parenteral technology, biologics or combination products
- Proficiency with the use of global systems (e.g., Systems, Applications and Products (SAP), Document Control and Archiving (DCA))
- Good verbal and written communication skills essential

LI-Hybrid

**Uniquely Interesting Work, Life-changing Careers**

**On-site Protocol**

BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on be

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