Compliance Manager - GMP
About The Position
The Compliance Manager is responsible for leading and supporting quality and compliance activities for GMP laboratories, with a primary focus on achieving and sustaining ISO/IEC 17025 and ISO 13485 certifications. This role provides oversight of quality system development, inspection readiness, and certification audit management to ensure alignment with GMP and applicable regulatory and accreditation requirements. The ideal candidate will serve as a key quality partner to laboratory operations and cross-functional teams, driving quality system maturity, risk mitigation, and sustained compliance in a regulated laboratory environment.
Requirements
- Bachelor’s degree in life sciences, chemistry, engineering, or a related scientific discipline.
- 8+ years of experience in a GMP-regulated laboratory or quality environment.
- Hands-on experience supporting ISO/IEC 17025 and/or ISO 13485 certification efforts.
- Strong working knowledge of GMP regulations and laboratory quality systems.
- Proven experience in deviation management, root cause analysis, and CAPA.
- Demonstrated ability to work cross-functionally and influence stakeholders in a matrixed organization.
- Experience supporting audits and inspections in a regulated laboratory environment.
Nice To Haves
- Experience with electronic quality management systems (eQMS) such as Veeva Vault, TrackWise, or equivalent is a plus.
- In some cases, an equivalency consisting of a combination of appropriate education, training, and/or directly related experience may be considered.
- Thorough knowledge of GMP regulations and ISO laboratory standards.
- Strong understanding of laboratory operations, quality systems, and inspection readiness.
- Excellent written and verbal communication skills.
- Strong leadership, organizational, and problem-solving abilities.
- Ability to assess risk, prioritize activities, and manage multiple initiatives simultaneously.
- High attention to detail and a continuous improvement mindset.
- Strong digital literacy and ability to learn and leverage quality systems and tools.
- Ability to work independently and collaboratively in a fast-paced environment.
- Flexibility and adaptability in a changing regulatory landscape.
- Ability to qualify for and maintain a corporate credit card for business travel.
Responsibilities
- Lead and coordinate GMP laboratory readiness activities to support ISO/IEC 17025 and ISO 13485 certification and ongoing compliance.
- Drive the development, implementation, and maintenance of quality system documentation, including SOPs, policies, quality manuals, and training materials.
- Serve as the primary point of contact for certification audits, surveillance audits, and inspection readiness activities.
- Partner with laboratory operations, quality, and regulatory stakeholders to plan and execute certification and recertification activities.
- Lead and support deviation management, root cause analysis, and CAPA development to ensure effective and sustainable remediation.
- Maintain compliance documentation, metrics, and audit records in alignment with GMP and ISO requirements.
- Support internal audits, external audits, and regulatory inspections as a subject matter expert (SME) for GMP laboratory compliance.
- Deliver training and guidance to laboratory and support teams on GMP and ISO requirements and quality system expectations.
- Analyze compliance and audit trends to identify risks, drive continuous improvement, and support strategic quality initiatives.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
