✦ Luna Orbit — Healthcare & Medical

Head of QA Technical Operations

at Bristol-Myers Squibb

📍 Summit West - NJ - US Hybrid 💰 $223K – $270K USD / year Posted March 30, 2026
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Position Details

Salary $223K – $270K USD / year
Type Full-Time
Experience executive
Exp. Years 15+ years
Education Bachelor's degree in Science or Engineering
Category Healthcare & Medical

About this role

Sr. Director, Quality Technical Operations leads QA oversight of deviations, CAPA, and change controls for Summit Cell Therapy Manufacturing, with responsibility for regulatory compliance, audits, and QA transformation programs.

Key Responsibilities

  • QA oversight of deviations, CAPA, and change controls
  • Directs Operations, Facilities, QC, and QA teams
  • Leads QA transformational programs
  • Ensures GMP documentation and risk assessments
  • Manages QA budget

Technical Overview

Deep GMP/regulatory expertise in cell therapy and biologics manufacturing; manages qualification/validation of computerized systems and manufacturing processes; interacts with Health Authorities and ensures inspection readiness.

Ideal Candidate

An executive-level QA leader with 15+ years in GMP/biologics cell therapy manufacturing, capable of directing QA operations, audits, and cross-functional regulatory interactions across a Summit, NJ facility.

Must-Have Skills

Bachelor's degree in relevant Science or Engineering15+ years of experience in managing Quality Assurance functionAt minimum 7 years of people management experienceExpertise in GMP as related to PharmaceuticalBiotech and/or ATMP ManufacturingExperience with implementing and overseeing GMP operations in a plant manufacturing clinical and commercial productsBackground in Biologics or Cell Therapy ManufacturingDemonstrated experience building and leading exceptional teamsExcellent written and verbal communicationCross-functional collaboration

Nice-to-Have Skills

Lean Six SigmaGMP operations leadershipAudits and regulatory interactions

Required Skills

GMPcGMPCAPAChange Controlsdeviationsqualificationvalidationcell therapyBiologicsS12AuditsHealth AuthorityRegulatory inspectionsDelegate of AuthorityQA leadershiprisk managementcross-functional collaborationcommunication

Hard Skills

GMPcGMPCAPAChange Controlsdeviationsqualificationvalidationcell therapyBiologicsS12AuditsHealth AuthorityRegulatory inspectionsDelegate of AuthorityQA leadershiprisk management

Soft Skills

LeadershipCommunicationStrategic thinkingCollaborationInfluencingProblem-solvingMentoring

Certifications

Preferred

Lean Six Sigma

Industry & Role

Industry Pharmaceuticals
Job Function Lead QA operations and regulatory compliance for Summit Cell Therapy Manufacturing
Role Subtype QA Lead

Keywords for Your Resume

QA Technical OperationsQuality AssurancecGMPCAPAChange Controlsdeviationsqualificationvalidationcell Therapy ManufacturingBiologicsS12AuditsHealth AuthorityRegulatory inspectionsDelegate of AuthorityQA leadershipS12 facilityAudit readinessRegulatory interactionsQuality leadershipGMPcell therapy

Deal Breakers

Less than 15 years QA/leadership experience, No cell therapy/biologics background, No GMP/ATMP manufacturing experience

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