Bristol Myers Squibb · 3 days ago
Senior Manager, Quality Assurance Investigations in Devens, MA
Devens, MA
Full-time
Onsite
Senior Level, Lead/Staff
$139K/yr - $168K/yr
8+ years expBristol Myers Squibb is a leader in cell therapy, striving to transform patients' lives through innovative science. The Senior Manager, Quality Assurance Investigations will oversee quality assurance processes at the Cell Therapy Facility, ensuring compliance with industry standards and managing personnel involved in investigations and corrective actions.
BiotechnologyHealth CareMedicalPharmaceuticalPrecision Medicine
Responsibilities
Manages and executes operating procedures for the site quality assurance program for the investigation and resolution of deviations, CAPA, and complaints
Provides direct supervision of personnel approving investigations and CAPA
Performs review and approval of site and department SOPs
Develop and manage the training curriculum of direct reports as it relates to investigations, CAPA, change controls, protocols and reports
Provide oversight of Investigations/CAPA management and tracking to ensure timely and compliant closure
Contributes to and supports the site team which prepares for, hosts and responds to regulatory inspections, reviews and approvals of the facility and products
Directly participates in internal audits or reviews as well as global health authority inspections
Hires, integrates and develops high quality talent, capable of delivering against the department goals and objectives
Establish and communicates performance objectives for Quality Assurance staff that are consistent with the company goals and objectives
Defines and enforces performance measures, provides developmental feedback and coaching and creates a collaborative environment enhances unit performance and integration across site departments
Provides oversight to identify and implement changes that lead to realization of long-term department goals
Qualification
Required
Knowledge of science generally attained through studies resulting in a B.S. in science, engineering, biochemistry or related discipline, or its equivalent is required
Strong background and demonstrated effectiveness in quality assurance operations
Knowledge of US and EU cGMP regulations and guidance
Knowledge and proven experience in FDA, EMA, or other regulatory authority
Demonstrated leadership, interpersonal, communication, and motivation skills
Directs quality initiatives that accomplish continuous improvement and enhance site manufacturing efficiencies, while providing a safe and compliant process
Must be action-oriented and customer-focused and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, resource allocation, coaching others, and analytical thinking
Must possess an independent mindset and tenacity
Requires moderate direction to complete more complex tasks; completes routine tasks with little or no supervision
Work is self-directed
Confident in making decisions, able to anticipate Quality issues and proactively solve problems
Routinely recognizes Quality issues and solves problems
Is recognized Subject Matter Expert within the group
Able to prepare written communications and communicate problems to management with clarity and accuracy
Able to effectively multi-task
Demonstrated experience with electronic system and databases
Demonstrated proficiency in root cause analysis tools including but not limited to 5-WHY, Human error prevention, Ishikawa Diagram (Fishbone Analysis), Process Flow Diagram, etc
A minimum of 8-12 years' experience in biopharmaceutical operations with prior management experience required
Experience in building and growing an organization into a high-performance team
Preferred
Knowledge of cell therapy, analytical testing or biotech bulk and finished product manufacturing is highly desirable
Benefits
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.
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
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.
Company
Bristol Myers Squibb
At Bristol Myers Squibb, we work every day to transform patients’ lives through science.
10001+ employees
H1B Sponsorship
Bristol Myers Squibb has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (247)
2024 (278)
2023 (231)
2022 (180)
2021 (181)
2020 (169)
Funding
Current Stage
Public CompanyTotal Funding
$29.32BKey Investors
Venrock
2025-11-05Post Ipo Debt· $5.74B
2024-02-14Post Ipo Debt· $13B
2023-10-30Post Ipo Debt· $4.5B
Leadership Team
Charles Bancroft
CFO
Cristian Massacesi
Executive Vice President, Chief Medical Officer and Head of Development
Recent News
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