Quality Compliance Lead: Inspections & Regulatory Readiness

Tolmar; Fort Collins (CO); On-site; USD 135,000 - 145,000; Full time

Benefits offered by this job

Bonus eligible

Job summary

Tolmar is seeking a Quality Compliance Manager to lead site compliance programs, audits, and regulatory readiness. The role requires directing quality systems, CAPA processes, and performance metrics across the site, ensuring alignment with U.S. and international standards.

The position oversees annual reviews, recalls, and regulatory notifications, collaborating with Regulatory Affairs, leadership, and external partners. A strong quality background and hands-on leadership are essential.

Qualifications

• Bachelor’s degree is required in science, engineering, life sciences, chemistry, or related field.
• Ten or more years of progressive QA, regulatory affairs, and/or compliance experience in a regulated environment.
• Experience interfacing with FDA and other regulatory agencies is required.

Responsibilities

• Lead inspections and audits, including FDA surveillance and pre-approval inspections, and coordinate readiness activities.
• Own the audit management process within the EQMS/inspection-management system and oversee budgets.
• Develop and manage risk-based internal and supplier audit programs with CAPA follow-up and governance reporting.
• Maintain records of audits and CAPAs and ensure timely closure of findings.
• Provide leadership for quality policy deployment, training, and continuous improvement initiatives.

Skills

Regulatory compliance

Audit management

Quality systems

Inspection readiness

Leadership

Education

Bachelor's degree in science, engineering, life sciences, chemistry, or related

Advanced degree preferred

Tools

EQMS

EDMS

Job description

Tolmar is seeking a Quality Compliance Manager to lead site compliance programs, audits, and regulatory readiness. The role requires directing quality systems, CAPA processes, and performance metrics across the site, ensuring alignment with U.S. and international standards.

The position oversees annual reviews, recalls, and regulatory notifications, collaborating with Regulatory Affairs, leadership, and external partners. A strong quality background and hands-on leadership are essential.