Inspection-Ready Quality Compliance Manager

Tolmar-7; Fort Collins (CO); On-site; USD 120,000 - 180,000; Full time

Job summary

Tolmar-7 is seeking a Quality Compliance Manager to provide leadership for all site compliance programs and ensure products meet quality requirements. The role covers inspections, audits, QMR/QRB programs, and regulatory notifications, with emphasis on data integrity and recall readiness.

The ideal candidate will guide quality policies, coach the team, and collaborate with cross-functional partners to maintain a robust Quality Management System aligned with U.S. and global regulations.

Qualifications

• Extensive knowledge of U.S. and international regulatory requirements and standards (cGMP, GDP, GLP)
• Ability to communicate with regulatory agencies, clients, auditors, and senior leadership
• Experience coordinating cross-functional inspection-preparation projects and compliance-improvement initiatives

Responsibilities

• Lead site compliance programs and audits.
• Manage inspection readiness and regulatory inspections (FDA, etc).
• Ensure quality systems meet cGMP and GDP requirements.
• Oversee APQR/PQR processes and quality metrics.

Skills

Quality compliance

Regulatory affairs

Audit management

Leadership

Job description

Tolmar-7 is seeking a Quality Compliance Manager to provide leadership for all site compliance programs and ensure products meet quality requirements. The role covers inspections, audits, QMR/QRB programs, and regulatory notifications, with emphasis on data integrity and recall readiness.

The ideal candidate will guide quality policies, coach the team, and collaborate with cross-functional partners to maintain a robust Quality Management System aligned with U.S. and global regulations.