Senior Scientist, QC Compliance
About The Position
At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it. Position Summary: Subject matter expert leading and authoring QC deviations, laboratory investigations, CAPAs and change control. Represent department in internal/external inspections. May author responses to regulatory requests and inspection and may support authoring of APQR sections for QC
Requirements
- Advanced ability to accurately and completely understand, follow, interpret and apply Global Regulatory and cGMP requirements.
- Advanced problem-solving ability/mentality, critical thinking, technically adept and logical.
- Advanced ability to communicate effectively with peers, department management and cross-functional peers about task status, roadblocks and needs.
- Ability to work in a fast-paced team environment, action oriented, highly organized to meet deadlines and prioritize work from multiple complex investigations and projects.
- Advanced mentoring, coaching, influencing, negotiating and personnel interaction skills.
- Bachelor’s degree in science, engineering, or related discipline.
- 8+ years of experience in biopharmaceutical or QC lab operations with 2+ years of prior investigation experience required.
- Demonstrated advanced experience with Quality management systems.
- Demonstrated advanced technical writing skills.
- Demonstrated advanced experience in laboratory or biomanufacturing investigations and root cause analysis techniques.
Nice To Haves
- Advance degree preferred.
- Knowledge of analytical and microbiological testing preferred.
- An equivalent combination of education and experience may substitute.
Responsibilities
- Subject matter expert leading and authoring QC deviations, laboratory investigations, CAPAs and change controls.
- Apply technical and compliance knowledge of regulatory requirements to conduct root cause analysis and laboratory investigation on non-routine complex investigation.
- Ensure timely and compliant closure of investigations, deviations, CAPAs and change controls.
- Generate and report KPIs. Highlight and escalate at risk items. Analyze and report CAPA effectiveness.
- Own document revision, projects, CAPA and deviation/ investigation, change management and/ or continuous improvement efforts.
- Train and mentor others on deviation, investigation, CAPA and change control process/ procedures.
- Represent department in internal/ external inspections. May author responses to regulatory requests and inspections and represent the department in governance & review boards.
- May support authoring of APQR sections.
- Communicate effectively with management and cross functional teams (e.g., present investigation findings at governance forums).
- Perform other tasks as assigned.
Benefits
- wellbeing support
- retirement and financial protection benefits
- insurance offerings (medical, dental, vision, life and disability)
- Flexible Time Off (FTO)
- 11 paid company holidays
- paid sick leave
- up to two paid volunteer days per year
- summer hours flexibility
- leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs
- annual Global Shutdown between Christmas Day and New Year's Day
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Senior
