Quality Control Investigation Lead

---

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.

Bristol-Myers Squibb in Devens, MA is searching for a remarkable Quality Control Investigation Lead to join our phenomenal team. Reporting to the Senior Manager, Quality Shared Services (QSS), the Quality Control Investigation Lead supports Commercial Drug Substance Quality Control (QC) Laboratory and Manufacturing Operations to maintain compliance with GMP requirements and execute process improvement initiatives including Deviation investigation, CAPA implementation, and continuous improvement projects. This position offers the opportunity to provide strong and highly visible leadership of the site investigations and CAPA programs. The successful candidate will lead highly technical and complex QC deviations and laboratory investigations by setting appropriate objectives and priorities and overcoming obstacles; by delivering results within investigation timelines; and by building and maintaining effective collaborations with site support organizations (e.g., QC Laboratories, Manufacturing, Stability, Supply Chain, Digital Plant, Site Engineering and Quality Assurance).

Key responsibilities:

• Manages resolution of complex/multi-functional deviations, root cause investigations, QC Laboratory investigations, impact assessments and CAPAs as site lead investigator.
• Present investigations to cross-functional leadership teams for endorsement of root cause and CAPA.
• Knowledge of regulatory requirements (e.g., US, EU, USP) and industry best practices.
• Directly participates in internal audits or reviews as well as global health authority inspections, serving as Subject Matter Expert (SME) as applicable
• Supports the QC Data Trending team with investigational requests and other duties as required.
• Drafts and reviews SOPs, Work Instructions and change controls.
• Establishes high performance standards, defines clear accountability, and leads by developing, adopting and supporting continuous improvement.
• Uses Quality Risk Management and Operational Excellence principles to facilitate risk-based decision-making, drive continuous improvement, and eliminate waste.

Qualification:

• BS in chemistry, biochemistry, molecular biology, biological sciences, or a related discipline (or equivalent experience).
• A minimum 4-7 years of relevant experience with strong experience in the documentation, investigation and resolution of quality observations relating to deviations in the QC laboratories.
• Demonstrates a strong knowledge of cGMP compliance, BMS corporate, site and regulatory agency requirements and procedures.
• Broad knowledge of QC laboratory operations and complex biologics assays, stability programs, biopharmaceutical facility design and manufacturing operations.
• Experience with biopharmaceutical regulatory submissions and interaction with regulatory agency inspectors.
• Successful experience working with cross-functional project teams from Quality Control, Quality Assurance, Manufacturing, Stability, Engineering, Documentation Control, Analytical Science & Technology (AS&T), Materials Sciences & Technology (MS&T) and Regulatory.
• Demonstrated ability to work with independently while adhering to investigation and CAPA timelines and goals.
• Strong general laboratory and organizational skills, effective communication skills, both verbal and written.
• Experienced with utilizing multiple root cause analysis tools.
• Excellent presentation skills.
• Ability to effectively interact with cross-functional area management, outside customers and peer groups across various departments.
• Creative problem solver.
• Strong attention to detail required.
• Interpersonal/facilitation skills necessary to interface with and influence all levels of the organization with the ability to lead people and multi-disciplinary teams.
• Knowledge of applicable business system including: SAP, LES, LIMS, Maximo, Trackwise, and Veeva desired.

BMSBL, BMSDMA, VETERAN

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.

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 . Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

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

<!– job description page –>