Senior QC Manager, Biopharma Quality Control

Genezen; Indianapolis (IN); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Paid vacation

Sick time

401(k)

Health plans

Job summary

Genezen is seeking a Manager/Senior Manager of Quality Control to lead QC laboratory operations supporting viral vector programs. You will oversee investigations, data integrity, CAPAs, and regulatory readiness while partnering with QA, Manufacturing, and Regulatory Affairs to ensure product quality and timely release.

The role requires building a high-performance QC team, driving continuous improvement, and maintaining inspection readiness in a fast-growing biopharma environment in

Qualifications

• BS in Molecular Biology, Biochemistry, Chemistry or related field.
• MS in Molecular Biology, Biochemistry, Chemistry or related field (Desired).
• 5-8 years progressive QC experience; 3-5 years in leadership.

Responsibilities

• Lead day-to-day QC laboratory operations.
• Oversee investigations (OOS/OOT) and CAPA programs.
• Manage stability programs and data review.
• Ensure cGMP compliance and inspection readiness.

Skills

Leadership

Quality systems

cGMP knowledge

Regulatory compliance

Data integrity

Environmental monitoring

Laboratory operations

Root cause analysis

CAPA

LIMS familiarity

Education

BS in Molecular Biology, Biochemistry, Chemistry

MS in Molecular Biology, Biochemistry, Chemistry

Tools

LIMS

Laboratory automation

Job description

Genezen is seeking a Manager/Senior Manager of Quality Control to lead QC laboratory operations supporting viral vector programs. You will oversee investigations, data integrity, CAPAs, and regulatory readiness while partnering with QA, Manufacturing, and Regulatory Affairs to ensure product quality and timely release.

The role requires building a high-performance QC team, driving continuous improvement, and maintaining inspection readiness in a fast-growing biopharma environment in