Job Title: Senior Manager, Specialty Laboratory QA
Location: Princeton, NJ / New Brunswick, NJ (Hybrid)
Department: Research & Development Quality – Nonclinical Compliance & Quality (NCQ)
Reports To: Director, Nonclinical Compliance & Quality (NCQ)
Position Summary
The Senior Manager, Specialty Laboratory QA is responsible for conducting Quality System audits for clinical and nonclinical laboratories that perform bioanalytical and biomarker work under Good Clinical Laboratory Practices (GCLP), Good Laboratory Practice (GLP), and Good Clinical Practice (GCP) regulations. The role serves as a Quality and Compliance Subject Matter Expert (SME) and ensures that internal and external laboratories comply with governmental regulations, study protocols, and company procedures.
Key Responsibilities
1. Regulatory Compliance & Audit Execution
Maintain in-depth knowledge of GCLP, GLP, GCP regulations and BMS policies governing bioanalytical and biomarker analyses.
Conduct Quality System audits at internal R&D sites, functional areas, and external contract laboratories to assess regulatory compliance.
Prepare audit documentation, conduct audits per the audit plan, and compile clear, accurate, and evidence-based audit reports.
Assess corrective action plans and track the resolution of audit findings.
Ensure proper documentation of all audits in the audit database.
Lead or participate in cross-functional audits (domestic and international) in collaboration with other auditing teams or stakeholders.
2. Subject Matter Expertise & Stakeholder Collaboration
Serve as a key regulatory compliance advisor to stakeholders across GCLP, GLP, and GCP areas.
Act as a mentor for NCQ auditors, guiding them in audit preparation, execution, reporting, and follow-up.
Engage with scientific and managerial personnel at contract research organizations (CROs) during facility evaluations.
Maintain regular communication with regulatory agencies (e.g., FDA, USDA) during inspections and follow-up activities.
Collaborate with external colleagues and trade associations to stay updated on industry best practices.
3. Training, Documentation & Inspection Readiness
Assist in developing and maintaining departmental standard operating procedures (SOPs).
Participate in or lead regulatory training programs for personnel involved in preclinical and clinical studies.
Lead or coordinate inspection readiness activities and regulatory agency inspections (e.g., FDA audits).
Support enterprise-level quality initiatives within Research & Development Quality (RDQ) and Global Quality (GQ).
Qualifications & Experience
Education & Certifications:
Bachelor’s degree in a relevant scientific field (e.g., Biology, Chemistry, Pharmacology).
Advanced degree (MS/PhD) preferred but not required.
Experience:
At least 6 years of experience in the biopharmaceutical industry or a related technical field.
Minimum 4 years of audit experience in a highly regulated environment (GCLP, GLP, GCP).
Experience managing regulatory agency inspections (e.g., FDA, USDA).
Proven ability to assess and interpret bioanalytical and biomarker compliance requirements.
Strong background in quality assurance, compliance, and laboratory auditing.
Experience in developing corrective action plans and risk mitigation strategies.
Technical & Soft Skills:
Strong knowledge of global regulatory requirements (FDA, EMA, PMDA, etc.) for bioanalytical and biomarker testing.
Excellent analytical, problem-solving, and decision-making skills.
Strong communication and stakeholder engagement abilities.
Ability to work independently while also collaborating with cross-functional teams.
Proficiency in audit reporting tools and compliance databases.
Work Environment & Travel
This role follows a hybrid work model (Princeton, NJ / New Brunswick, NJ).
Travel: ~10% (including visits to BMS sites, contract research organizations, and professional conferences).
Why Join Bristol Myers Squibb?
At BMS, we are committed to transforming patients’ lives through science. We foster an inclusive, collaborative environment that empowers employees to drive innovation and make a meaningful impact.
Apply today and be part of a team that ensures the highest quality standards in clinical and nonclinical laboratory research!
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