Position Details

Type Full-Time

Experience lead

Exp. Years 15+ years

Education Bachelor's degree in relevant Science or Engineering discipline

Category QA & Testing

About this role

Sr. Director, Quality Technical Operations leads QA oversight of cGMP operations at the Summit NJ cell therapy manufacturing facility, driving CAPA, deviation management, change controls, and qualifications/validations of computerized systems, while building and guiding a high-performing QA organization.

Key Responsibilities

QA oversight of cGMP operations deviations, CAPAs, Change Controls, and qualification/validation of computerized systems
Provides direction to Operations, Facilities, QC, and QA teams for deviation strategy and CAPA
Leads site-wide QA transformation programs with cross-functional partners
Ensures timely QA support and approval of GMP documentation, risk assessments and change control impact assessments
Manages annual QA operating budget

Technical Overview

Expertise in GMP regulations, QA strategy, and validation of computerized systems; leadership of QA transformation initiatives; strong regulatory and health authority interaction experience.

Ideal Candidate

The ideal candidate is a senior QA leader with 15+ years in pharmaceutical manufacturing, deep GMP/CGMP and CAPA experience, with 7+ years of people management, capable of driving QA transformations and leading regulatory interactions.

Must-Have Skills

Bachelor's degree in relevant Science or Engineering discipline and 15+ years of experience in managing Quality Assurance function; at minimum 7 years of people management experience.Expertise in Good Manufacturing Practices (GMP) as related to PharmaceuticalBiotech and/or ATMP Manufacturing.Experience with implementing and overseeing GMP operations in a plant manufacturing clinical and commercial products is required

Nice-to-Have Skills

Background in Biologics or Cell Therapy Manufacturing is preferredDemonstrated experience building and leading exceptional teamsLean Six Sigma expertise

Required Skills

Bachelor's degree in relevant Science or Engineering discipline; 15+ years of experience in managing Quality Assurance function; at minimum 7 years of people management experience; GMP; GMP operations; CAPA; Change Controls; qualification/validation of computerized systems; regulatory inspections; audit readiness; Deviations management; Quality Engineering; Cell Therapy Manufacturing; Biologics; Lean Six Sigma

Hard Skills

GMPQuality AssuranceCAPAChange ControlsQualification and validation of computerized systemsGMP documentationRegulatory inspections

Soft Skills

LeadershipCommunicationInterpersonal skillsCross-functional collaborationProblem solving

Certifications

Preferred

Lean Six Sigma

Industry & Role

Industry Healthcare & Medical

Job Function Lead QA Technical Operations for cell therapy manufacturing with GMP compliance and high-performing team leadership

Role Subtype QA Lead

Keywords for Your Resume

Bachelor's degree in relevant Science or Engineering discipline15+ years of experience in managing Quality Assurance function7 years of people management experienceGMPCAPAChange Controlsqualification/validation of computerized systemsGMP operationscell therapy manufacturingbiologicsregulatory inspectionsaudit readinessQuality SystemsDeviations managementLean Six Sigmavalidationquality assurancecell therapy

Deal Breakers

Lack of 15+ years QA experience, No GMP/CGMP expertise, No people management experience

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