Quality Control Leader, GMP & Regulatory Excellence

American Society for Quality; Waukesha (WI); On-site; USD 110,000 - 140,000; Full time

Job summary

Werfen is seeking a Manager of Quality Control to lead the QC team within the Transplant Technology Center. You will report to the Sr. Director QA/RA and drive strategic direction, budget planning, and audit readiness.

This role requires hands-on leadership to align quality goals with product development and manufacturing. The position emphasizes collaboration with QA, Regulatory Affairs, R&D, and Operations to ensure compliance with FDA, ISO 13485, and MDSAP, while driving continuous

Qualifications

• Bachelor’s degree or related field required.
• Minimum 7 years of clinical laboratory experience with In-Vitro Diagnostics; HLA screening and Elisa products preferred.
• Minimum 5 years of people management experience; GMP environment preferred.
• Strong analytical, communication, and leadership skills.
• Management may substitute relevant work experience for a degree or adjust experience requirements.

Responsibilities

• Leads QC team with strategic direction and SMART goals.
• Partners cross-functionally with QA, Regulatory Affairs, R&D, Manufacturing, and Operations.
• Ensures QC adherence to SOPs and regulatory standards (FDA, ISO 13485, 21 CFR 820, MDSAP).
• Drives continuous process improvements and efficiency across QC operations.
• Manages department budget, equipment purchases, and system implementations.
• Sets and tracks department KPIs and presents at QRB and MRB.
• Leads investigation governance for OOS, CAPA, and NCR investigations.
• Authors/updates SOPs, FORs and TMPs.
• Represents QC in Validation Plans, Protocols and PDP projects.
• Oversees QC stability program planning and scheduling.

Skills

Effective communication

Strong leadership

Proactive problem-solving

Strategic thinking

Organizational skills

Time management

Coaching skills

Continous learning

Conflict resolution

Positive work environment

Education

Bachelor’s Degree in Medical Technology

Bachelor’s of Science Degree in a related field

Job description

Werfen is seeking a Manager of Quality Control to lead the QC team within the Transplant Technology Center. You will report to the Sr. Director QA/RA and drive strategic direction, budget planning, and audit readiness.

This role requires hands-on leadership to align quality goals with product development and manufacturing. The position emphasizes collaboration with QA, Regulatory Affairs, R&D, and Operations to ensure compliance with FDA, ISO 13485, and MDSAP, while driving continuous