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cGMP COMPLIANCE MANAGER
cGMP COMPLIANCE MANAGERFrontall USA • Hildale, Utah, United States
cGMP COMPLIANCE MANAGER

cGMP COMPLIANCE MANAGER

Frontall USA • Hildale, Utah, United States
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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.
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    Compliance Manager • Hildale, Utah, United States

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