Manager, Quality Operations, External Manufacturing Americas - New Brunswick New Jersey

Company: Disability Solutions
Location: New Brunswick, New Jersey
Posted On: 05/04/2024

Working with UsChallenging. 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.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 with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us .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
  • 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., Systems, Applications and Products (SAP), Document Control and Archiving (DCA))
  • Good verbal and written communication skills essential #LI-HybridIf you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Uniquely Interesting Work, Life-changing CareersWith a single vision as inspiring as Transforming patients' lives through science--- , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.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 behalf of BMS as directed is an essential job function. BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/ eeo -accessibility to access our complete Equal Employment Opportunity statement. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. More...

        

    ---

    Register an account with us and set up job agents! We'll email you immediately when jobs like this are posted on our site.

    ---