Position Details

Type Full-Time

Experience lead

Exp. Years 3 years

Education Doctorate, Master's, Bachelor's, Associate, or High School diploma with required experience

Category QA & Testing

About this role

Manager, Quality Assurance leads QA oversight of manufacturing packaging activities, ensuring cGMP/GDP compliance, and oversees quality systems including deviations, CAPA, change control, and validation. This role drives investigations, audits, and continuous improvement across assigned areas.

Key Responsibilities

Lead Quality staff across assigned areas and shifts
QA oversight of manufacturing packaging for cGMP/GDP compliance
Review, approve, and oversee Deviations, CAPA, Change Controls, Validation docs and batch records
Drive investigations and resolution of deviations
Represent QA during audits and regulatory inspections

Technical Overview

Focus on GMP/GDP regulated manufacturing environments with strong emphasis on deviations, CAPA, validation, document control, and regulatory inspections. Requires cross-functional collaboration with Manufacturing, QC, Engineering, and Supply Chain.

Ideal Candidate

The ideal candidate is a senior quality professional with 3+ years of quality leadership in a GMP-regulated setting, capable of driving Deviations, CAPA, Change Control, and Validation activities. They excel at cross-functional collaboration, regulatory audits, and building a culture of quality and compliance at scale.

Must-Have Skills

Doctorate degree OR Master's degree and 3 years of quality experience OR Bachelor's degree and 5 years of quality experience OR Associate's degree and 10 years of quality experience OR High school diploma / GED and 12 years of quality experienceExperience directly managing people and/or leadership experience

Nice-to-Have Skills

Bachelor's degree in Life SciencesEngineeringor related field3+ years of QA within a GMP-regulated environmentPrior leadership or people management experienceDeep knowledge of cGMPGDPand regulatory expectationsExperience with quality systems (deviationsCAPAchange controlvalidation)

Tools & Platforms

GMP systemsDocument Control SoftwareCAPA tracking systems

Required Skills

Doctorate degree OR Master's degree and 3 years quality experience OR Bachelor's degree and 5 years quality experience OR Associate degree and 10 years quality experience OR High school diploma / GED and 12 years quality experience; Deviations; CAPA; Change Controls; Validation; Batch Records; cGMP; GDP; GMP; Manufacturing Packaging; Audit readiness; Regulatory inspections; Document Control; Quality Systems; Risk Assessment

Hard Skills

cGMPGDPDeviationsCAPAChange ControlsValidationBatch RecordsAuditsRegulatory inspectionsDocument ControlQuality SystemsQuality AssuranceManufacturing PackagingRisk AssessmentGMP-Regulated EnvironmentQuality Oversight

Soft Skills

LeadershipCommunicationDecision-makingProblem-solvingCollaborationInfluence across functionsMentoringAttention to detail

Certifications

Preferred

SAFe Agile CertificationGxP related certifications (e.g.GMP/QA) if applicable

Industry & Role

Industry Biotech & Pharmaceuticals

Job Function Lead quality assurance and regulatory compliance for manufacturing operations at Amgen in Ohio.

Role Subtype QA Manager

Keywords for Your Resume

manager pqaquality assuranceqa managergmpcgmpgdpdeviationscapachange controlsvalidationbatch recordsaudit readinessregulatory inspectionsdocument controlquality systemsrisk assessmentmanufacturing packagingcross-functionalpharmabiotechbiopharmaceuticalleadershippeople managementchange control

Deal Breakers

Lack of GMP/regulatory experience, No leadership/people management experience, Inadequate QA systems experience (deviations, CAPA, change control, validation)

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Manager PQA

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