Supervisor Quality Compliance

Supervisor Quality Compliance

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Supervisor Quality Compliance based in the United States.

This is a leadership opportunity overseeing Quality Compliance activities within a regulated pharmaceutical environment. The role is responsible for strengthening inspection readiness, audit management, and the effectiveness of quality systems. You will guide a high-performing team while partnering closely with cross-functional stakeholders and regulatory authorities. Your work will directly support GMP compliance, product quality, patient safety, and continuous operational improvement. The position combines strategic oversight with hands-on involvement in audits, inspections, quality reviews, risk assessments, and CAPA activities.

You will also use quality metrics and trend analysis to identify risks, inform senior leadership, and drive better business decisions. The role is primarily based in Fort Collins, Colorado, with some travel required for inspections, audits, and team collaboration.

• Lead and oversee the Quality Compliance team, managing daily activities, priorities, performance, development, and accountability.
• Build and maintain a strong culture of quality, compliance, candid communication, continuous improvement, and inspection readiness.
• Manage regulatory, internal, third-party, and customer audits and inspections, including preparation, execution, observations, responses, and follow-up activities.
• Own and maintain the inspection readiness program, including training, readiness assessments, facility walkthroughs, steering committee activities, budgets, and audit management systems.
• Serve as a key representative during regulatory inspections, including front-room and back-room coordination, document production, and communication with inspectors and authorities.
• Lead internal audit planning and execution using risk- and budget-based approaches, ensuring findings are appropriately documented and addressed.
• Oversee CAPA activities, root-cause investigations, risk assessments, audit responses, and remediation strategies to prevent recurrence of compliance issues.
• Manage Quality Management Review and Quality Review Board programs, ensuring governance processes, meeting requirements, metrics, and documentation remain compliant and effective.
• Oversee Field Alert and regulatory notification processes, ensuring submissions are accurate and completed within required timelines.
• Manage the product recall system, including mock recalls and coordination with internal stakeholders, affiliates, distributors, and regulatory agencies.
• Lead the Annual Product Quality Review process from scheduling through completion, reviewing product quality metrics, identifying trends, and ensuring appropriate corrective actions.
• Develop and maintain quality KPIs, analyze trends, and prepare management reporting and presentations for senior leadership.
• Develop, implement, review, and approve Quality Compliance policies, procedures, SOPs, and related documentation.
• Provide regulatory interpretation and guidance regarding changing FDA, international, GMP, GDP, GLP, ISO, and industry requirements.
• Collaborate with local, global, and cross-functional teams to standardize processes and implement quality improvements.
• Coach, mentor, train, and develop Quality Compliance employees, including participation in hiring, onboarding, performance evaluations, and professional development.
• Support GMP, GDP, and quality systems training and contribute to cross-functional initiatives as a Quality Compliance subject matter expert.

• Bachelor's degree in a scientific, engineering, or technical discipline.
• At least 8 years of experience in Quality and/or Compliance within the pharmaceutical industry.
• At least 5 years of experience managing inspections and audits, including regulatory and/or internal audits; relevant certifications may be considered in lieu of some experience.
• At least 3 years of experience leading or managing quality system elements, such as deviations/nonconformances, internal audits, training,…