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Senior GMP Quality Manager

Katalyst CRO

Role overview

Qualifications

  • Bachelor's degree in a scientific or technical discipline
  • 8+ years GMP Quality experience in pharma, including late-stage drug product development and validation
  • Sponsor-side CMO oversight experience — clinical-stage across DS/DP/FP, or commercial-stage specifically on drug substance
  • Experience with process validation (PPQ) and late-stage/commercial regulatory submissions

Responsibilities

  • Lead sponsor-side QA oversight of CMOs across pre-clinical, clinical, and commercial manufacturing — drug substance, drug product, and final product
  • Own quality oversight for commercial-stage drug substance activities, including process validation (PPQ) and disposition
  • Serve as QA SME on deviations, CAPAs, change controls, and documentation revisions
  • Review and approve CMO documentation, batch records, and test data; perform product dispositions

Key facts

Hard skills

Other skills

  • Quality Assurance
  • Leadership
  • Problem Solving

About the company

Katalyst CRO logo

Katalyst CRO

Contract Research Organizations (CRO)

Katalyst CRO | Advancing Healthcare & Life Sciences with Expert Research & Regulatory Solutions Katalyst Healthcare & Life Sciences (Katalyst CRO) is a Global Contract Research and Knowledge Process Outsourcing Organization (CRO) dedicated to driving innovation in research, regulatory compliance, and quality excellence for pharmaceutical, biotechnology, and medical device companies worldwide. With a strong foundation in cGxP & ICH-GCP-compliant clinical research, we offer fully customizable, end-to-end solutions, covering everything from pre-clinical studies to Phase I–IV clinical trials, regulatory affairs, and validation services—ensuring seamless drug and device development. Our Expertise Across the Product Lifecycle: 🔹 Pre-Clinical Research & Development – In-Vitro (Lab-Based) & In-Vivo (Animal) Studies 🔹 Clinical Research & Development – Trial Management, Data Management, Biostatistics, Medical Writing, Pharmacovigilance 🔹 Regulatory & Quality Compliance – cGxP (GMP, GLP, GCP) Validations, Regulatory Affairs, Process & System Validations 🔹 Strategic Human Resourcing – Connecting top-tier talent to life sciences and healthcare organizations With deep industry expertise and a flexible, client-centric approach, Katalyst CRO leverages an advise-build-operate model to de-risk and accelerate research programs. We help organizations achieve regulatory success, optimize quality systems, and bring life-changing therapies to market faster—ultimately improving global patient health and safety. 💡 Partner with Katalyst CRO to bring breakthrough therapies to market with confidence. 📩 Let’s connect and shape the future of healthcare together!

Company details

IndustryContract Research Organizations (CRO)
Company size51 - 200

Links

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Job description

Key Responsibilities
  • Lead sponsor-side QA oversight of CMOs across pre-clinical, clinical, and commercial manufacturing — drug substance, drug product, and final product
  • Own quality oversight for commercial-stage drug substance activities, including process validation (PPQ) and disposition
  • Serve as QA SME on deviations, CAPAs, change controls, and documentation revisions
  • Review and approve CMO documentation, batch records, and test data; perform product dispositions
  • Support quality review of regulatory submissions (IND/IMPD, NDA) and participate in inspection readiness
  • Represent QA cross-functionally with CMC, Supply Chain, and Analytical Development
  • Maintain quality metrics and periodically revise GMP SOPs
Qualifications
  • Bachelor's degree in a scientific or technical discipline
  • 8+ years GMP Quality experience in pharma, including late-stage drug product development and validation
  • Sponsor-side CMO oversight experience — clinical-stage across DS/DP/FP, or commercial-stage specifically on drug substance
  • Experience with process validation (PPQ) and late-stage/commercial regulatory submissions
  • Inspection readiness experience (domestic and/or ex-US) preferred

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Marcus Rivera

Chief Revenue Officer

m.rivera@company.com
linkedin.com/in/marcusrivera
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