GMP Auditor – Medical Devices (Ex-FDA Preferred)
Location: United States (Onsite Audit – San Diego, California)
Engagement Type: Full-Time / Contract Assignment
Duration: Approximately 30 Hours
Planned Timeline: Early March 2026
Compensation: Competitive Rate + Travel & Expenses
Job Requisition ID: JR 9033
About ProPharma
ProPharma is a global life sciences consulting leader with over 20 years of experience supporting pharmaceutical, biotechnology, and medical device companies. Through its integrated advise–build–operate model, ProPharma delivers regulatory, quality, clinical, pharmacovigilance, medical information, and R&D technology solutions across the entire product lifecycle.
Our teams partner with clients worldwide to strengthen compliance, accelerate development, and ensure successful regulatory outcomes for complex and high-impact programs.
Position Overview
ProPharma is seeking an experienced GMP Auditor – Medical Devices, preferably with prior FDA regulatory experience, to conduct a comprehensive onsite GMP audit at a medical device manufacturing facility in San Diego, CA.
This role will focus on evaluating Quality Management Systems (QMS), manufacturing operations, and regulatory compliance against FDA 21 CFR, EU GMP, and ICH standards. The auditor will also deliver an instructor-led training and interactive workshop as part of the engagement.
Key Responsibilities
GMP Audit Execution
Conduct a comprehensive onsite GMP audit of medical device operations.
Review and assess SOPs and Quality Management System (QMS) documentation.
Evaluate compliance of production and quality systems with:
FDA 21 CFR 210/211
EU GMP requirements
ICH Q7 (as applicable)
Quality Systems Assessment
Assess core QMS elements, including:
Facilities and equipment systems
Materials management systems
Laboratory controls
Packaging and labeling systems
Vendor qualification, contracts, and supplier relationships
Product and manufacturing documentation
Perform site layout evaluation and on-site facility walkthroughs.
Review records, reports, and data integrity controls.
Regulatory & Personnel Engagement
Conduct interviews with key operational and quality personnel.
Evaluate management responsibilities and quality oversight.
Identify compliance gaps, risks, and improvement opportunities aligned with regulatory expectations.
Training & Knowledge Transfer
Prepare and deliver an 8-hour instructor-led GMP training and interactive workshop.
Customize training content to reflect audit findings, regulatory requirements, and best practices.
Required Qualifications
Education
Bachelor’s degree or higher in Life Sciences, Engineering, Pharmacy, or a related discipline.
Experience
Minimum 10–15 years of GMP auditing or regulatory compliance experience within the medical device, pharmaceutical, or regulated life sciences industry.
Former FDA experience strongly preferred, including roles such as FDA Investigator, Compliance Officer, or Regulatory Reviewer.
Extensive hands-on experience conducting GMP audits and inspections.
Strong working knowledge of FDA 21 CFR 210/211, EU GMP, and ICH guidelines.
Proven experience auditing QMS, manufacturing systems, and vendor controls.
Prior experience delivering GMP training or regulatory workshops is highly desirable.
Key Skills & Competencies
Expert understanding of global GMP and regulatory inspection standards.
Strong audit planning, execution, and reporting capabilities.
Excellent communication and stakeholder engagement skills.
Ability to identify regulatory risks and propose practical remediation strategies.
High attention to detail with strong documentation and analytical skills.
Professional judgment and independence in regulated environments.
Diversity & Equal Opportunity
ProPharma is committed to fostering a diverse, inclusive, and equitable workplace. We welcome applications from qualified professionals of all backgrounds and ensure equal opportunity in all employment practices.
Application Process
All applications are personally reviewed by ProPharma’s recruitment team. Candidates will receive direct feedback on the outcome of their application.
Important Notice: ProPharma Group does not accept unsolicited resumes from recruitment agencies or third parties.
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