Senior Supplier Quality Auditor

Bristol Myers Squibb

Senior Supplier Quality Auditor at RayzeBio leading supplier audits for compliance in the pharmaceutical sector. Collaborating with suppliers and stakeholders for CAPA development and regulatory inspections.

Posted 7/31/2026full-timeRemote • 🇺🇸 United StatesSenior💰 $96,148 - $116,508 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in conducting supplier audits and ensuring compliance with GxP regulations, including FDA and EMA standards. Proficient in developing CAPAs and maintaining audit records while providing training and guidance on quality assurance processes.

Highest-signal resume keywords

Supplier AuditingGxP ComplianceCAPA DevelopmentQuality AssuranceRegulatory Knowledge

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

AuditingQuality AssuranceRegulatory ComplianceGMPGLPGCPCAPA ManagementRisk AssessmentDocument ManagementContinuous Improvement

Soft Skills

CollaborationCommunicationTrainingProblem-SolvingStakeholder Engagement

Industry Keywords

PharmaceuticalBiotechnologyCGMPFDAEMAICH Guidelines21 CFREudraLexQuality AgreementsSOPs

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Plan, schedule, and conduct onsite and remote audits of suppliers and external service providers in accordance with the approved supplier audit program.
Evaluate supplier compliance with applicable regulatory requirements (e.g., FDA, EMA, ICH), internal SOPs, and executed quality agreements.
Document supplier audit observations and collaborate with suppliers and internal stakeholders to develop appropriate and effective CAPAs.
Track supplier CAPAs to closure and verify timely implementation and effectiveness.
Maintain complete and accurate supplier audit records and ensure timely communication of audit results and risk assessments.
Support regulatory inspections and inspection readiness activities related to supplier oversight and audit programs.
Provide guidance and training to suppliers and internal teams on supplier audit processes and GxP compliance expectations.
Participate in continuous improvement initiatives related to supplier quality oversight and supplier audit processes.

Requirements

What you’ll need

Bachelor’s degree in Life Sciences, Chemistry, or a related field or equivalent experience.
Minimum of 7 years of experience in quality assurance, auditing, or supplier management within the pharmaceutical, biotechnology, or cGMP industry.
Auditing experience within regulated biotech/pharma industry or equivalent in a GxP-regulated environment, with at least 3 years in auditing or quality assurance.
Strong knowledge of global GxP regulations and standards (e.g., 21 CFR Parts 11, 210, 211; EudraLex Volume 4; ICH Guidelines).
Experience conducting audits across GMP, GLP, and/or GCP domains.
Demonstrable ability to identify systemic quality and compliance risks.

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.
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.