Quality Compliance Lead (Hybrid/Remote)

Tolmar Inc.; Fort Collins (CO); Hybrid; USD 120,000 - 180,000; Full time

Job summary

Tolmar Inc. in Fort Collins seeks a Quality Compliance Manager to lead site compliance programs, audits, and quality systems alignment with FDA and global requirements. You will oversee inspection readiness, regulatory notifications, and CAPA, while guiding data integrity efforts across operations.

You will mentor the Quality Systems & Compliance team, collaborate with cross-functional partners, and ensure cGMP/GDP adherence, incident investigations, and continuous improvement initiatives.

Qualifications

• Extensive knowledge of US and international regulatory requirements.
• Experience leading site-wide quality programs and audits.
• Strong ability to coach and develop quality teams.

Responsibilities

• Provide site-level compliance leadership and deploy quality programs.
• Lead inspection readiness and audit management for regulatory bodies and customers.
• Maintain and improve QMS, data integrity, and CAPA processes.
• Oversee APQR, PQR, and recall readiness activities.
• Collaborate with Regulatory, Manufacturing, and QA functions to ensure compliance.

Skills

Quality systems

Audits

Regulatory compliance

Leadership

Data integrity

GxP/regulatory knowledge

Tools

EQMS

CAPA tracking

Job description

Tolmar Inc. in Fort Collins seeks a Quality Compliance Manager to lead site compliance programs, audits, and quality systems alignment with FDA and global requirements. You will oversee inspection readiness, regulatory notifications, and CAPA, while guiding data integrity efforts across operations.

You will mentor the Quality Systems & Compliance team, collaborate with cross-functional partners, and ensure cGMP/GDP adherence, incident investigations, and continuous improvement initiatives.