Associate Director, Principal Product Quality Lead
Bristol Myers Squibb
full-time
Posted on:
Location Type: Hybrid
Location: Madison • Massachusetts, New Jersey, Washington • 🇺🇸 United States
Visit company websiteSalary
💰 $162,860 - $217,073 per year
Job Level
Senior
About the role
- Provide global product quality oversight and support for external manufacturing / partnerships and internal manufacturing operations including developing and maintaining relationships with site QA, QC, analytical and process development, manufacturing sciences and technology, and regulatory affairs functions.
- Supports the overall product quality strategy based on CMC deliverables, technical team objectives, life-cycle improvements, and regulatory commitments.
- Provides technical quality expertise and compliance oversight in accordance with global regulatory requirements and internal policies in support of life-cycle management activities.
- Review clinical and commercial regulatory filings as needed.
- Demonstrate the ability to influence others through persuasive interactions and garner support for novel solutions where applicable.
- Show the capacity to operationalize theoretical concepts into actionable plans and execute those plans with successful outcomes.
- Chairs the Analytical Subteam meetings between Site QA/QC, Analytical Development, Process Development, Manufacturing Sciences and Technology, Product Sciences, and Regulatory Affairs.
- Coordinates program specific presentations to the Product Quality Review Board / Product Specification Committee and other product quality related cross-functional teams.
- Serves as QA reviewer / approver for analytical and process protocols and reports, stability protocols and reports.
- Owner of product release and stability specifications and strategy.
- Provide strategic guidance and facilitate the timely implementation of global changes with respect to the assigned product.
- Owns global changes and documentation management activities as required.
- Assist in the continuous improvement and lifecycle management of GMP operations, including providing guidance and direction for transitioning from clinical to commercial phase.
- Serves as quality oversight for product and stability trend investigations.
Requirements
- BS/MS in relevant Science or Engineering discipline and 10+ years of experience in Quality in a biotech, pharmaceutical, or bio-pharmaceutical organization; 1-3 years of experience in a supportive PQL role is preferred.
- Expertise in Lentiviral Vector manufacturing or analytics with validation experience is a plus.
- Expertise in GMP compliance, global regulations, and strong understanding of pharmaceutical product development lifecycle are required.
- Experience with review of market applications, IND, supplements or similar regulatory documentation is required.
- Demonstrated technical skillset with analytics and/or process development is preferred.
- Demonstrated ability in decision making and problem solving is required.
- Demonstrated Quality leadership through partnership in a matrixed-organization is required.
- Background in Vaccines, Biologics, or Cell Therapy Manufacturing is required.
- Must be able to effectively operate and deliver in a continuously evolving regulatory and operations landscape.
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.
- Work-life benefits include: Paid Time Off US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays).
- Additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
Lentiviral Vector manufacturingGMP complianceregulatory documentation reviewanalyticsprocess developmentproduct quality strategylife-cycle managementquality oversightstability protocolsclinical to commercial transition
Soft skills
influencepersuasive interactionsoperationalize conceptsdecision makingproblem solvingleadershipcollaborationcommunicationstrategic guidancecontinuous improvement