Sr. Manager, Quality Assurance -CMO

Job Description

Position may be located in Summit NJ or Seattle WA

Senior Manager QA – Vector CMOs

BMS is a global biopharmaceutical company committed to improving the lives of patients worldwide. At BMS, we seek to deliver truly innovative and life-changing treatments for our patients.

Our Vector CMO Quality Assurance team is responsible for overseeing and supporting external manufacturing operations of our global CMO partners. The Senior Manager QA (CMO) position is an individual contributor role responsible for providing QA oversight of CMO operations in accordance with business agreements and international regulatory and industry standards.

Primary Responsibilities include:

• Develop supplier qualification practices that use risk-based tools for assessments, qualification and performance monitoring that consider KPI development/tracking and operational deliverables.
• Develops and implements policies and procedures for CMO compliance; including development of Quality Agreements, Quality Business Processes, Product Disposition and Quality Event Resolution (Deviations and Supplier Corrective Action Request in accordance with organizational strategy and business realities.
• Ensures approved quality systems are established and maintained to BMS quality standards and regulatory requirements.
• Partner closely with BMS External Manufacturing team and the Virtual Plant Team to ensure consistent and collaborative messaging to external manufacturing partners.
• Work cross functionally to provide a single point of contact for QA technical support to internal teams and external manufacturing partners.
• Effectively communicatee issues, risks and proposed solutions within the organization.
• Assist with and provide QA approval of investigations, CAPAs, changes, validation documentation, and other related GMP documentation.
• Provide communication, support, and guidance to manufacturing partners and within the QA CMO team.
• Serves as a Quality subject matter expert on Vector and Cell Bank related production teams.
• Perform batch record review and lot disposition activities as required
• Support internal and external audits as needed, including PLI/PAI preparations.
• Other duties as assigned.
• Up to 35% travel.

Basic Qualifications:

• Bachelor’s degree in biochemistry, cell biology, microbiology, chemistry, engineering or closely related areas.
• Experience managing external suppliers and supply chain-related issues.
• 15+ years related industry experience with a minimum of 5 years’ experience in quality assurance, quality control, and compliance.
• Strong organizational skills, including ability to follow assignments through to completion.
• Advanced skills in leading, influencing, negotiating, and supplier management.
• Independent decision-making capability and ability to think strategically and understand global impact of decisions.
• Excellent verbal and written communication skills.
• Proven leadership and mentoring skills for junior staff.
• Proven ability to work effectively in a matrixed organization
• Advanced knowledge of relevant regulations and guidance for Cell Therapy products. Able to act as a resource for colleagues.
• Audit and inspection management experience.
• Ability to prioritize and successfully manage complex and competing projects.
• Detail-oriented with expertise in problem solving and solid decision making abilities.

Preferred Qualifications:

• Experience with Cellular Therapeutics and/or gene based products.
• Experience with product launch including PLI/PAI.
• Experience with Commercial products manufacture, supply and post-approval change management.
• Advanced project management skills such as process excellence/six sigma methods and approaches including process mapping, root cause analysis and problem definition.
• Experience in a fast-paced matrixed environment