Quality Assurance Team Lead

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

As a Quality Assurance Team Lead, you will spearhead our on-site quality initiatives, ensuring that all production processes adhere to rigorous cGMP standards. You will play a pivotal role in maintaining compliance, driving continuous improvement, and overseeing the release of high-quality pharmaceutical products to the global market.

About the Role

As a Quality Assurance Team Lead, you will spearhead our on-site quality initiatives, ensuring that all production processes adhere to rigorous cGMP standards. You will play a pivotal role in maintaining compliance, driving continuous improvement, and overseeing the release of high-quality pharmaceutical products to the global market.

Responsibilities

• Lead and mentor the on-site QA team, managing daily workflows, training, and performance evaluations to ensure operational excellence.
• Oversee the inspection and release of raw materials, intermediate products, and finished goods based on established specifications.
• Manage the lifecycle of quality documentation, including batch record reviews, deviations, investigations, change controls, and CAPAs.
• Drive the development and maintenance of robust Quality Management Systems (eQMS) to ensure alignment with FDA, ICH, and industry regulatory requirements.
• Collaborate with cross-functional teams to identify facility events, ensuring accurate documentation and timely resolution.
• Compile and present key quality metrics to leadership to support data-driven decision-making and process improvements.
• Participate in internal and external audits, proactively addressing findings to uphold the highest standards of quality compliance.

Required Skills

• Associate degree in a relevant field.
• 5+ years of experience in a regulated pharmaceutical or biopharmaceutical quality environment.
• Demonstrated proficiency in cGMP, batch record review, and quality management systems.
• Strong leadership capabilities with experience in workload management and team coordination.

Preferred Skills

• Bachelor’s degree in a scientific or related discipline.
• 10+ years of progressive experience in quality assurance roles.
• Advanced knowledge of MasterControl or similar eQMS platforms.
• Proven track record in regulatory audit participation and CAPA management.