Senior Specialist, Supplier Quality

Bristol Myers Squibb

Quality Specialist overseeing supplier activities for Bristol Myers Squibb. Ensuring compliance with regulatory requirements and managing Supplier Quality risk assessments.

Posted 7/16/2026full-timeMassachusetts, New Jersey • 🇺🇸 United StatesSenior💰 $98,340 - $127,638 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Supplier Quality Oversight and Quality Assurance within the pharmaceutical and biopharmaceutical sectors, with a strong focus on cGMP compliance, risk assessment, and continuous improvement initiatives. Proficient in managing supplier quality agreements and conducting audits while effectively collaborating with cross-functional teams.

Highest-signal resume keywords

Supplier Quality OversightCGMP KnowledgeRisk Assessment ExperienceCAPA ManagementQuality System Documentation

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Quality AssuranceSupplier QualificationChange ControlDeviations/OOS ManagementInvestigationsAnalytical SkillsBatch Disposition PrinciplesContinuous ImprovementAseptic Manufacturing ProcessesSterile Products Manufacturing

Soft Skills

Problem SolvingNegotiation SkillsTeam SpiritAction-OrientedCustomer-Focused

Tools & Technologies

Project Management ToolsQuality Management System SoftwareOffice Software

Industry Keywords

Pharmaceutical IndustryBiopharmaceutical EnvironmentFDA RegulationsEU RegulationsJP Regulatory RequirementsICH GuidelinesCell Therapy Manufacturing

About the role

Key responsibilities & impact

Quality oversight of the activities and services provided by suppliers.
Serves as a single point of QA contact for indirect suppliers supporting CT manufacturing sites.
Assists with supplier qualification activities of new and current suppliers.
Initiate and Manage Supplier Quality risk assessments.
Create / negotiate and maintain Supplier Quality Agreements.
Work closely with the suppliers and involve SMEs to ensure proper and timely resolution.
Evaluate and communicate supplier quality related changes.
Participate in BMS audits at suppliers, as needed.
Coordinate / Support Supplier Quality Vendor Changes and Supplier Issue.
Collect supplier quality documentation necessary to support regulatory submissions.
Hold appropriate periodic quality meetings with supplier representatives.
Hold or actively participate in joint periodic meetings with stakeholders.
Initiate and assess Change control, complaints, deviations/OOS and CAPA management in electronic system.
Partner with stakeholders to assess overall supplier performance.
Provide timely support and necessary information to QA colleagues and Quality/Supply Chain Management as required.
Act as representation for Quality Operations as required, escalate critical issues to Management as appropriate.
Author necessary quality system documents; review and update procedures for BMS Quality Management System per process ownerships.
In partnership with the CoEx sponsor, define and execute the short‑ and long‑term strategy for the assigned Center of Excellence.
Serve as the CoEx subject matter expert, driving initiatives, continuous improvement, KPI performance.
Create detailed plans of the CoEx activities using Project Management tools.
Support Health Authority inspections and audits of the site.

Requirements

What you’ll need

BS or MS or equivalent education in science, or related fields.
Minimum 3-5 years of experience in a pharmaceutical/biopharmaceutical environment including previous QA experience – e.g. QA compliance role, Supplier Quality oversight.
Thorough knowledge of cGMP in the pharma/Biotech industry as well as FDA, EU, and JP regulatory requirements, ICH guidelines.
Experience in Supplier Quality oversight.
Knowledge of cell therapy manufacturing processes and testing is a plus.
Good knowledge of sterile products manufacturing processes and testing.
Knowledge of aseptic manufacturing processes.
Experience with performing/participating in risk assessment exercises.
Thorough knowledge of and competence in core quality processes - including change control, deviations/OOS, CAPA management, investigations, APR-PQR.
Excellent investigational and QA problem solving skills.
Analytical mindset.
Quality performance / continuous improvement oriented.
Good understanding of batch disposition principles, aligned with QP concept and associated duties.
Skilled in planning and organizing, building relationships, innovation management and resource allocation.
Ability to make independent and objective decisions and to work under minimal supervision with cross functional teams and partners worldwide.
Team spirit.
Action-oriented and customer-focused.
Negotiation and persuasion skills.
Good knowledge of most common office software.
Good verbal and written communication skills in English.

Benefits

Comp & perks

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).
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.