Quality Assurance Team Lead - Pharma, cGMP & Compliance

Accelera; Waunakee (WI); On-site; USD 90,000 - 130,000; Full time

Job summary

Accelera in Wisconsin is seeking a Quality Assurance Team Lead to champion on-site quality initiatives and ensure production processes meet strict cGMP standards. You will drive continuous improvement and oversee the release of high-quality pharmaceutical products for global markets.

You will lead the QA team, manage batch records and CAPAs, and collaborate with cross-functional groups to maintain FDA/ICH-aligned quality systems. This role requires strong leadership and audit experience.

Qualifications

• Must hold an associate degree or higher in a relevant scientific field.
• Minimum 5 years in a regulated pharma/biopharma quality environment.
• Demonstrated proficiency in cGMP, batch record review and QA systems.
• Strong leadership and team coordination capabilities.

Responsibilities

• Lead and mentor the on-site QA team and manage daily workflows.
• Oversee inspection and release of materials and finished goods.
• Manage batch records, deviations, investigations, and CAPAs.
• Develop and maintain robust eQMS aligned with FDA/ICH standards.
• Collaborate across functions to document facility events and resolutions.
• Present quality metrics to leadership to drive improvements.
• Participate in internal and external audits and address findings.

Skills

cGMP knowledge

Batch record review

Quality management systems

Leadership

Regulatory audit participation

CAPA management

Education

Associate degree in a relevant field

Bachelor’s degree in a scientific field

Tools

MasterControl or similar eQMS

Job description

Accelera in Wisconsin is seeking a Quality Assurance Team Lead to champion on-site quality initiatives and ensure production processes meet strict cGMP standards. You will drive continuous improvement and oversee the release of high-quality pharmaceutical products for global markets.

You will lead the QA team, manage batch records and CAPAs, and collaborate with cross-functional groups to maintain FDA/ICH-aligned quality systems. This role requires strong leadership and audit experience.