Sr. QA Specialist Vector VQM

Profile

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

Senior Specialist 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 QA Specialist 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:


Partner closely with BMS External Manufacturing team and the Virtual Plant Team to ensure consistent and collaborative messaging to external manufacturing partners where assigned as VQM.
Work cross functionally to provide a single point of contact for QA technical support to internal teams and external manufacturing partners.
Effectively communicate 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.
Facilitates implementation of policies and procedures for CMO compliance; including development of Quality Agreements, Quality Business Processes, Product Disposition and Quality Event Resolution in accordance with team derived strategy and business realities.
Perform batch record review and lot disposition activities as required.
Proven ability to work effectively in a matrixed organization
Support internal and external audits as needed
Create and revise Standard Operating Procedures as needed.
Other duties as assigned.
Up to 30% travel.


Basic Qualifications:

8 years of experience in a GMPs environment. Must have Bachelor's degree in biochemistry, cell biology, microbiology, chemistry, engineering or closely related areas.


8 years related industry experience with a minimum of 3 years' experience in quality assurance, quality control, and compliance.
Knowledge of applicable FDA/EMA regulations in the biotechnology industry.
Strong organizational skills, including ability to follow assignments through to completion.
Experience influencing and negotiating.
Knowledge of relevant regulations and guidance documents for Cell Therapy products.
Strong decision-making capability and ability to ask compelling questions and to think strategically and understand global impact of decisions.
Excellent verbal and written communication skills.
Detail-oriented with skills in problem solving and solid decision making abilities.


Preferred Qualifications:


Experience within the Cellular Therapeutics and/or gene based products.
Experience with Commercial products manufacture, supply and post-approval change management
Experience providing oversight to external suppliers and other supply chain issues.
Strong project management skills such as process excellence/six sigma methods and approaches including process mapping, root cause analysis and problem definition.


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 the resources to pursue their goals, both at work and in their personal lives.

Company: Bristol-Myers Squibb

Req Number: R1526300_EN

Updated: 2020-06-16 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.

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