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Senior Manager, Quality Assurance

Katalyst CRO

Role overview

Qualifications

  • Bachelor's degree in a scientific or technical discipline
  • 8+ years of pharmaceutical industry experience
  • Demonstrated QA oversight of transport validation and packaging process validation strongly preferred
  • Experience managing quality aspects of validation, packaging, and testing at CMOs

Responsibilities

  • Lead QA oversight of transport validation and primary/secondary packaging validation for drug product and finished packaged product at CMOs to support commercial readiness
  • Serve as QA representative on cross-functional teams, providing guidance on quality and compliance based on current global regulations and industry standards
  • Act as QA SME on deviations, CAPAs, change controls, and documentation revisions
  • Establish and report quality metrics, risks, and compliance challenges to senior management

Key facts

Hard skills

Other skills

  • Quality Assurance
  • Collaboration
  • Management
  • Time Management

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

Responsibilities:
  • Lead QA oversight of transport validation and primary/secondary packaging validation for drug product and finished packaged product at CMOs to support commercial readiness.
  • Serve as QA representative on cross-functional teams, providing guidance on quality and compliance based on current global regulations and industry standards.
  • Act as QA SME on deviations, CAPAs, change controls, and documentation revisions.
  • Review and approve CMO documentation, including specifications, master and executed batch records, label proofs, and validation documentation.
  • Establish and report quality metrics, risks, and compliance challenges to senior management.
  • Periodically review and revise GMP SOPs and procedures.
  • Support inspection readiness for commercial launch.

Qualifications:

  • Bachelor's degree in a scientific or technical discipline.
  • 8+ years of pharmaceutical industry experience.
  • Demonstrated QA oversight of transport validation and packaging process validation strongly preferred.
  • Experience managing quality aspects of validation, packaging, and testing at CMOs.
  • Experience with process validation (PPQ), commercial readiness, and domestic/ex-US inspection readiness.
  • Solid knowledge of US and global GMP regulations and industry practices.
  • Strong collaboration and management skills with the ability to handle multiple priorities on aggressive timelines.

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MR

Marcus Rivera

Chief Revenue Officer

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