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.