Location
Seattle, WA, United States
Posted on
Jun 18, 2020
Profile
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.
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 from our Seattle WA Dexter location. 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
Around 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.
Company: Bristol-Myers Squibb
Req Number: R1526264_EN
Updated: 2020-06-17 00:00:00.000 UTC
Location: Seattle,Washington
Bristol 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.
Company info
Sign Up Now - MiamiCrossing.com
Employer job 
90 Day Old Job 
