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.