Senior Scientist, QC Compliance

Bristol-Myers Squibb Co; Bothell (WA); On-site; USD 120,000 - 146,000; Full time

Benefits offered by this job

Stock options

Discretionary bonus

Flexible Time Off

Job summary

Bristol Myers Squibb in Bothell, WA, is seeking a Subject matter expert to lead and author QC deviations, investigations, CAPAs and change controls. You will represent the department in inspections and may support regulatory responses.

You will train others, manage document revisions, and drive continuous improvement while collaborating with cross-functional teams to present findings at governance forums. The role requires a bachelor’s in science or engineering and 8+ years in biopharma or QC

Qualifications

• Bachelor’s degree in science, engineering, or related discipline; advanced degree preferred.
• 8+ years of biopharmaceutical or QC lab operations experience with 2+ years of investigations.
• Knowledge of analytical and microbiological testing; experience with quality management systems.

Responsibilities

• Lead and author QC deviations, laboratory investigations, CAPAs and change controls.
• Apply regulatory and cGMP knowledge to root-cause analyses and investigations.
• Generate and report KPIs; escalate at-risk items and assess CAPA effectiveness.
• Own document revisions, CAPA/change-management projects and continuous improvement efforts.
• Train and mentor others on deviation, investigation, CAPA and change-control procedures.
• Represent department in inspections and regulatory responses; participate in governance reviews.

Skills

Regulatory knowledge

Analytical skills

Technical writing

Education

Bachelor’s degree in science/engineering

Advanced degree preferred

Job description

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:

Bothell - WA - US: $120,320 - $145,797

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 knowledge and experience you bring. Final compensation is guided by pay equity principles and applicable employment laws. Compensation programs are reviewed on an ongoing basis and may be adjusted over time to reflect evolving market factors, and individual, team or Company performance.

Benefits:

Subject to the terms and conditions of the applicable plans then in effect, you may be eligible to participate in our comprehensive benefit plans – including wellbeing support, retirement and financial protection benefits, and insurance offerings (medical, dental, vision, life and disability).

U.S.-based exempt employees are eligible for Flexible Time Off (FTO), which provides paid time off without a set accrual limit, subject to manager approval, along with 11 paid company holidays each year.

Non-exempt employees, RayzeBio employees, and employees located in Puerto Rico receive 160 hours of paid vacation annually for new hires (subject to manager approval), 11 paid company holidays, and 3 optional holidays.

Depending on eligibility, employees may also have access to additional time-off benefits, including paid sick leave, up to two paid volunteer days per year, summer hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs. Eligible employees also enjoy an annual Global Shutdown between Christmas Day and New Year's Day.

U.S.-based job seekers can explore full benefit offerings at https://careers.bms.com/benefits

How We Work

Where you work matters – because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at https://careers.bms.com/ways-of-working.

Supporting People with Disabilities

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to [e-mail]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

BMS will consider qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

For roles based in Los Angeles County only: If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

Data Protection

We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection.

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

If this posting is missing required information required by local law or incorrect, contact BMS at [e-mail] the Job Title and Requisition number. Do not send application-related inquiries to this email. To check your application status, please login to your Candidate Home Account.

R1606346 : Senior Scientist, QC Compliance