cGMP COMPLIANCE MANAGER

About the Client:

The client is a forward-thinking manufacturing company dedicated to making a positive impact on the world. Based in Hildale, Utah, they take pride in fostering a supportive, results-driven culture where every team member contributes to achieving shared goals. As an equal opportunity employer, the company values professionalism, integrity, and innovation in everything they do.

About the Role:

We are seeking a cGMP Compliance Manager to join our team in Hildale, UT. This full-time, in-person position is responsible for leading the cGMP Compliance Section, ensuring adherence to FDA, OSHA, and other regulatory standards. The successful candidate will manage a high-performing team, conduct internal audits, develop and maintain Standard Operating Procedures (SOPs), and drive process improvements to maintain premium quality standards.

Key Responsibilities:

• Supervise and lead the cGMP Compliance team, setting goals and monitoring performance.
• Delegate tasks effectively and provide clear instructions to team members.
• Develop, update, and enforce SOPs, quality standards, and safety protocols.
• Conduct internal audits and prepare detailed reports with recommendations.
• Support and oversee regulatory inspections, internal/external audits, NCR, and CAPA processes.
• Train staff in environmental and allergen testing, ensuring compliance with FDA standards.
• Analyze processes for inefficiencies and implement improvements using Lean, Six Sigma, or similar methods.
• Maintain documentation, trackers, and records to meet regulatory requirements.
• Foster a culture of accountability, safety, and operational excellence.
• Participate in hiring and onboarding of new team members.
• Schedule: MondayFriday, 8:00 a.m.5:00 p.m. (flexibility as needed)

Qualifications:

Required:

• High school diploma or GED.
• Minimum 1 year of experience in cGMP compliance in the pharmaceutical, biopharmaceutical, or medical device industry.
• Hands-on experience managing regulatory inspections, internal/external audits, NCR, and CAPA.
• Strong understanding of cGMP, allergen control, 21 CFR Part 111, OSHA, and FDA regulations.
• Knowledge of SOPs and Quality Management Systems (QMS).
• Excellent written and verbal communication skills.
• Strong analytical and problem-solving abilities.
• Ability to meet hygiene standards and not significantly allergic to soy, fruits, vegetables, fibers, or spices.
• Must not be color blind.

Preferred:

• 2+ years of experience in cGMP compliance within regulated manufacturing industries.
• Experience with Lean, Six Sigma, or other process improvement methodologies.
• Quality management and auditing experience.