Manager, External Supplier Quality - Vector & Plasmid CMOs

Company: Bristol Myers Squibb
Location: Summit
Posted on: January 27, 2023

Job Description:

At Bristol Myers Squibb, we are inspired by a single vision transforming patients lives through science. In oncology, hematology, immunology and cardiovascular disease and one of the most diverse and promising pipelines in the industry each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.Our Cell Therapy Vector, External Manufacturing Supplier Quality Assurance (SQA) team is responsible for overseeing, supporting external manufacturing operations and contract testing operations of our global external partners via flexible working options such as site-based, remote-by-design, and/or person-in-plant (25-50%) roles.The Manager External Supplier Quality (CMO) position is an individual contributor role responsible for providing QA oversight of CMO and CTL operations for Cellular Therapy products in accordance with business agreements and international regulatory and industry standards. This includes commercial programs, clinical programs, vector, plasmid, and novel technologies.Job Responsibilities

• Develops 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 Deviations, Corrective Actions in accordance with organizational strategy and business realities.
• Ensures approved quality systems are established and maintained to BMS quality standards and regulatory requirements.
• Participate in BMSs External Manufacturing team, Virtual Plant and Analytical Teams to ensure consistent and collaborative messaging to external manufacturing/testing partners.
• Work cross functionally to provide a single point of contact for QA technical support to internal teams and external manufacturing partners.
• Effectively communicates issues, risks and proposed solutions within the organization.
• Performs batch records review and release of vectors
• Provides QA review and approval of deviations, OOS, investigations, CAPAs, changes, validation documentation, and other related GMP documentation.
• Provides communication, support, and guidance to manufacturing partners and within the QA CMO team.
• Serves as a Quality subject matter expert on Vector, Plasmid and Cell Bank related production teams.
• Supports internal and external audits as needed, including PLI/PAI preparations.
• Supports Inspection Readiness Activities at CMOs
• Support KPI, metrics and other CMO Improvement Initiatives
• Ability to travel up to 35% (Domestic and International)Qualifications and Education Requirements
  • Bachelors degree or equivalent experience in biology, biochemistry, cell biology, microbiology, chemistry, engineering or closely related areas.
  • Experience managing external suppliers and supply chain-related issues.
  • 6+ 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 biologics and/or Cellular Therapeutics and/or gene based products.
    • Experience with product launch including PLI/PAI and/or tech transfer.
    • 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#LI-HybridAround the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.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.Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.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: R1563795Updated: 2023-01-22 04:05:12.495 UTCLocation: Summit,New JerseyBristol 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.

Keywords: Bristol Myers Squibb, New York , Manager, External Supplier Quality - Vector & Plasmid CMOs, Executive , Summit, New York