Senior Manager Quality Control Investigations

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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. Read more: Summary

Provide Quality Control (QC) leadership and ownership for site investigations and CAPA execution related to QC operations and laboratory activities. This role is accountable for ensuring investigations are scientifically sound timely and compliant while partnering closely with Quality Assurance for independent oversight and regulatory alignment.

Duties / Responsibilities

• Lead and manage the deviation and investigation process for Quality Control operations including analytical testing microbiology bioassay environmental monitoring and laboratory systems.

• Serve as the QC subject matter expert (SME) for root cause analysis CAPA development and effectiveness verification related to laboratory and testing-related events.

• Ensure investigations are data-driven scientifically rigorous and supported by appropriate laboratory evidence trending and risk assessment.

• Partner with Quality Assurance Manufacturing MSAT Engineering and Regulatory to ensure investigations meet regulatory expectations while accurately reflecting QC process and laboratory realities.

• Own monitoring and trending of QC-related investigation data to identify recurring issues systemic risks and opportunities for continuous improvement.

• Support internal audits and regulatory inspections by providing QC investigation expertise documentation and direct engagement with inspectors as needed.

• Develop standardize and deliver training for QC personnel on investigation best practices data integrity and compliance expectations.

• Drive continuous improvement initiatives within QC to strengthen investigation quality documentation consistency and inspection readiness.

• Ensure QC investigation activities comply with applicable global regulations (FDA EMA ICH) and internal quality standards.

Reporting Relationship

• Acts independently to determine methods and procedures for investigation execution within Quality Control.

• Receives assignments in the form of objectives and establishes goals to meet investigation compliance and performance expectations.

• Work is reviewed and measured based on meeting established objectives investigation timeliness quality and compliance metrics.

• Identifies and escalates risks trends and deviations from standard practices to senior management recommending and implementing corrective and preventive actions.

• Independent contributor with site-level influence across QC functions.

Qualifications required:

• Bachelors degree in Life Sciences Biotechnology Chemistry Microbiology or a related scientific discipline.

• 58 years of experience in Quality Control and/or GMP laboratory operations within the biotech or pharmaceutical industry.

• Demonstrated expertise leading laboratory investigations root cause analysis and CAPA management in a regulated environment.

• Strong working knowledge of cGMP regulations ICH guidelines data integrity principles and laboratory quality systems.

• Experience with electronic quality systems (e.g. Veeva TrackWise SAP) and laboratory informatics (e.g. LIMS) preferred.

This role maintains investigation ownership within Quality Control while preserving Quality Assurances independent oversight responsibilities.

BMSBL

If you come across a role that intrigues you but doesnt perfectly line up with your resume we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job such as required skills where the job is performed the employees work schedule job-related knowledge and experience. Final individual compensation will be decided based on demonstrated experience.

Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits please visit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include:

• Health Coverage: Medical pharmacy dental and vision care.

• Wellbeing Support: Programs such as BMS Well-Being Account BMS Living Life Better and Employee Assistance Programs (EAP).

• Financial Well-being and Protection: 401(k) plan short- and long-term disability life insurance accident insurance supplemental health insurance business travel protection personal liability protection identity theft benefit legal support and survivor support.

Work-life benefits include:

Paid Time Off

• US Exempt Employees: flexible time off (unlimited with manager approval 11 paid national holidays (not applicable to employees in Phoenix AZ Puerto Rico or Rayzebio employees)

• Phoenix AZ Puerto Rico and Rayzebio Exempt Non-Exempt Hourly Employees: 160 hours annual paid vacation for new hires with manager approval 11 national holidays and 3 optional holidays

Based on eligibility* additional time off for employees may include unlimited paid sick time up to 2 paid volunteer days per year summer hours flexibility leaves of absence for medical personal parental caregiver bereavement and military needs and an annual Global Shutdown between Christmas and New Years Day.

All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.

*Eligibility Disclosure: The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours depending on the nature of their work and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors leased workers and other service providers are not eligible to participate in the program.

Uniquely Interesting Work Life-changing Careers
With a single vision as inspiring as Transforming patients lives through science every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture promoting global participation in clinical trials while our shared values of passion innovation urgency accountability inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential site-by-design field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles onsite presence is considered an essential job function and is critical to collaboration innovation productivity and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

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 . Visit to access our complete Equal Employment Opportunity statement.

Candidate Rights

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

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: Protection

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