Senior Scientist, QC Compliance

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

Duties/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.

Qualifications

Specific Knowledge, Skills, Abilities:

• 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.

Education/Experience/

Licenses/Certifications:

• Bachelor’s degree in science, engineering, or related discipline. Advance degree preferred.
• 8+ years of experience in biopharmaceutical or QC lab operations with 2+ years of prior investigation experience required. An equivalent combination of education and experience may substitute.
• Knowledge of analytical and microbiological testing preferred.
• 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.

We hire for skills and capabilities, not just credentials – if this role excites you, but doesn’t perfectly match your resume, we encourage you to apply anyway.

Compensation Overview:

The starting pay range(s) listed above is for full-time employees (FTE). You may also be eligible for additional discretionary incentive cash and stock opportunities. We determine starting pay thoughtfully – carefully considering the nature of the role, required skills, work location, schedule and the…