Senior Microbiology QC Manager - GMP Leader

Genezen; Lexington (MA); Sur place; USD 130 000 - 170 000; Plein temps

Avantages offerts par ce poste

Paid vacation days

401(k) plan

Healthcare plans

FSA/HSA

Life insurance

Disability insurance

Résumé du poste

Genezen is hiring a Manager/Senior Manager for Quality Control - Microbiology in Lexington, Massachusetts. You will lead the QC Microbiology lab, supervise staff, ensure GMP compliance, and drive continuous improvement across QC systems.

The role requires strong microbiology expertise, regulatory knowledge, and a track record of managing complex testing programs. The position involves coordinating testing, data integrity, investigations of deviations, and collaboration with cross-functional

Qualifications

• BS in Microbiology/ Biology or related scientific discipline.
• 8+ years GMP Quality Control experience with at least 4 years management experience.
• Advanced knowledge of global GMP guidelines (US/EU).

Responsabilités

• Oversee QC Microbiology operations and resource planning.
• Ensure data integrity and timely reporting of results.
• Lead deviations, CAPA investigations and change controls.
• Manage outsourced testing activities and cross-functional collaborations.
• Support internal/external inspections and audits.
• Provide QC data support to cross-functional teams (CMC, QA).

Connaissances

Leadership

Decision making

Change management

Communication

Problem solving

GMP knowledge

Formation

BS in Microbiology/ Biology

Description du poste

Genezen is hiring a Manager/Senior Manager for Quality Control - Microbiology in Lexington, Massachusetts. You will lead the QC Microbiology lab, supervise staff, ensure GMP compliance, and drive continuous improvement across QC systems.

The role requires strong microbiology expertise, regulatory knowledge, and a track record of managing complex testing programs. The position involves coordinating testing, data integrity, investigations of deviations, and collaboration with cross-functional