Senior Manager API Quality Operations

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. 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.

The role

BMS Global Quality External Manufacturing is looking to recruit a Senior Manager API Quality Operations on a 12 month contract.

Job Function

Provide quality operations and compliance oversight management to Active Pharmaceutical Ingredient and intermediate contract manufacturing organisations (CMO) engaged by External Manufacturing within a cross functional team

• Proactively manage contract manufacturer relationships from a quality and compliance perspective. Build strong effective working relationships with CMO’s

• Quality lead for a Virtual Plant Team (VPT) or managing a significant portfolio at a CMO

• Develop and manage the quality events, change control and market complaints programs in respect of contract manufacturers. Ensure an effective deviation management system is in place to deal with vendor non-conformances from third party suppliers. Review process validation protocols and reports and also process verification/campaign reports for CMO’s where relevant.

• Ensure Quality by Design (QbD) principles are implemented for all new products at CMO’s. Review and approval of process risk assessment, process verification reports for CMO’s for intermediates and Active Pharmaceutical Ingredient (API). Support pre-approval inspections

• Manage all activities associated with vendor approvals

• Provide quality/compliance subject matter expertise to the wider Supplier Relationship Management, Global Procurement, Supply Chain and Manufacturing Science & Technology (MS&T) teams in support of new projects, technical transfers programs, supplier selection programs, investigations, validation programs, etc.

• Provide the requisite quality support to Global Bristol Myers Squibb (BMS) functional groups such as Global Regulatory/Chemistry Manufacturing and Controls (CMC) and the local country based regulatory managers in support of regulatory filings, product renewals, regulatory agency questions, etc.

• Manage the quality metrics programs in relation to CMO performance

• Serve as the Quality Operations Leader in Technical Transfer projects and Manufacturing Launch Teams (MLTs) relating to Third Parties

• Prepare, negotiate and approve Quality Agreements and purchase specs with CMO’s

• Review and approve the Annual Product Reviews submitted by the CMO’s Support the Global BMS external auditing program by participation in audits of Third Parties as requested

• Mange information/provide information for quality council meeting

• Assess and implement corporate policies and directives

• Liaise with auditors of external vendors and suppliers. Review vendor audits to identify trends. Manage audit observation closure.

• Review and update CMO Bona Fides as required

• Carry out annual risk assessments for CMOs

• Review and update stability protocols as necessary

• Proactive management of direct reports as necessary

• Review and approving goals and objectives for direct reports

• Proactively manage the development of direct reports

• Carry out batch release as required

Note: Travel will be required on a routine basis as part of this role (approx. 25%).

Qualifications, Knowledge and Skills Required:

• Minimum a BSc, preferably with a postgraduate qualification and minimum 5 years´ experience in a GMP manufacturing environment. Operational Excellence (OpEx) experience desirable.

• Five years’ experience in the pharmaceutical industry, specifically in API manufacture, preferably in Quality, Manufacturing Technology, Regulatory or a position within a Health Authority Agency.

• Extensive experience and technical knowledge in chemical, biological and/or pharmaceutical operations which enables first-hand knowledge of manufacturing, quality control, quality assurance, regulatory affairs/sciences, and interface with research & development

• In depth knowledge of current Good Manufacturing Practices (cGMP) regulations pertinent to the United States of America (USA), European Union (EU) and other international markets

• 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

• Exhibits BMS BioPharma Behaviors

• Strong analytical and problem solving skills

Why you should apply

• You will help patients in their fight against serious diseases
• You will be part of a company that encourages excellence and innovation, respects diversity, develops leaders and values its employees.
• You’ll get a competitive salary and a great benefits package including, but not only, an annual bonus, pension contribution, family health insurance, 27 days of annual leave , access to BMS Cruiserath on-site gym and life assurance

#LI-Hybrid

If 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 Careers
With 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 a supportive culture, promoting global participation 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 an 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.

Supporting People with Disabilities

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.

Candidate Rights

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

Data Protection

We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

If you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at TAEnablement@bms.com. Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response. Inquiries related to the status of your application should be directed to Chat with Ripley.

R1601601 : Senior Manager API Quality Operations