Hybrid Quality Compliance Supervisor

Tolmar-7; Fort Collins (CO); Hybrid; USD 100,000 - 115,000; Full time

Job summary

Tolmar is seeking a Supervisor Quality Compliance to lead the Quality Compliance team within the Quality Assurance Unit. You will oversee audits, inspections, CAPA activities, and field alerts with a focus on GxP compliance, ISO requirements, and regulatory reporting.

The role requires extensive experience in quality systems, audits, and managing cross-functional teams, with responsibility for ensuring inspection readiness and effective regulatory interactions.

Qualifications

• Bachelor’s degree in a scientific, engineering or technical discipline is required.
• Eight or more years of experience in Quality and/or Compliance in pharma.
• Experience with inspection management and audits preferred.

Responsibilities

• Lead and oversee Quality Compliance activities including audits, inspections, CAPA and regulatory reporting.
• Develop and manage Audit/Inspection Training for SMEs and participants.
• Ensure inspection readiness and manage the Inspection Readiness program and budget.
• Interface with regulatory agencies and partners to address deficiencies and prepare responses.
• Maintain SOPs, QA metrics and QMS documentation; drive continuous improvement.
• Coordinate with affiliates and distributors to ensure regulatory inspections are managed properly.

Skills

Regulatory knowledge

Auditing

Quality systems

CAPA management

Documentation management

Risk assessment

Cross-functional collaboration

Education

Bachelor’s Degree in scientific, engineering or technical discipline

Tools

EQMS

EDMS

Job description

Tolmar is seeking a Supervisor Quality Compliance to lead the Quality Compliance team within the Quality Assurance Unit. You will oversee audits, inspections, CAPA activities, and field alerts with a focus on GxP compliance, ISO requirements, and regulatory reporting.

The role requires extensive experience in quality systems, audits, and managing cross-functional teams, with responsibility for ensuring inspection readiness and effective regulatory interactions.