Associate Director, Quality operations ExM

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 .Required Qualification(s) and Desired Experience

B.S. in Natural Sciences, Chemistry, Microbiology, Biology, Engineering, Pharmacy or equivalent.

A minimum of 10 years' experience in pharmaceutical, biologics, biotech, or related industry with relevant 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.

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., Systems, Applications and Products (SAP), Document Control and Archiving (DCA))

Ability to understand the business implications regarding quality positions and decisions.

Ability to build relationships, partnerships, and influence and/or enforce quality decisions at external manufacturers.

Strong negotiation, communication, and presentation skills across all levels both internal and external to BMS.

Capable of managing 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 requirements are met.

Responsibilities:

Manages CMO(s) relationship(s) 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 (SOPs), authoring and executing Risk Mitigation Plans as needed Coordinates and or lead batch disposition, investigations, complaint, change control activities with peers within External Manufacturing and provide suitable direction to ensure personnel understand compliance requirements and current approved procedures.

Manage complex projects independently to ensure that project timelines and compliance needs are met or exceeded.

Such projects may include onboarding of new CMO, new product launches, upgrades and or new equipment installation, technology transfer to new facility, computer and quality system initiatives, and cross functional improvement initiatives. Support and deliver training to new and existing employees Review and approve and/or author supplement Annual Product Quality Reviews (APQRs) as required Investigate and/or evaluate manufacturing, packaging and laboratory deviations or incidents and associated Corrective Actions and/or Preventive Actions (CAPAs).

Provide direction and recommendations as to future course(s) of action Coordinate, author, review and approve Quality Agreements as required Review and approve as required validation/qualification protocols and reports from the External Manufacturer Write, review and implement SOPs to ensure compliance with current BMS standard and current Good Manufacturing Practices (cGMP)

Lead and or support on Fact Finding Investigation Team (FIT) and Fact-Finding Investigation Review Meetings (FIRM) and authoring of New Drug Application (NDA) Field Alerts Reports or other Health Authority notifications.

Lead and or 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

Lead and support 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) agency cGMP regulations and policies Quality.

Lead on cross-functional teams within the "Virtual Manufacturing Plant", Technical Transfer teams, Supplier Selection, Serialization, Manufacturing, Packaging launch teams.

Manage People (As Required)Selects and retains staff. Accountable for allocating resources such that the right person is doing the right work at the right time. Develops and mentors' staff. Provides feedback on performance against predefined objectives.Designee ResponsibilitiesThis position can be a designee for Director Quality Operations External Manufacturing (ExM) Americas.Contingency SupportList the Position(s) that provide backup for this role.In the absence of the Associate Director Quality Operations ExM Americas, the Senior Manager Quality Operations ExM Americas can act as a designed.#BMSBLIf 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 ProtocolBMS 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.Company: Bristol-Myers SquibbReq Number: R1584318Updated: 2024-08-11 05:49:14.995 UTCLocation: New Brunswick-NJBristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.