QC Chemistry & Device Testing Leader — Greenfield Lab Startup

Genentech; Holly Springs (NC); On-site; USD 120,000 - 223,000; Full time

Benefits offered by this job

Relocation assistance

Job summary

Genentech's Holly Springs site seeks an experienced leader to head QC Chemistry and Device Testing, establishing a start-up laboratory and delivering compliant, efficient testing for CVRM products. You will build a proactive quality culture, implement QMS processes, and partner across global QC networks to ensure regulatory readiness.

You will set KPIs, author methods and protocols, manage budgets, and drive Lean Leadership in a fast-paced, greenfield environment launching in the near term.

Qualifications

• Proven leadership in QC or manufacturing leadership within pharma/biopharma.
• Strong knowledge of analytical methods, method validation, and transfer.
• Experience with cGMP, ICH guidelines, and regulatory inspections.

Responsibilities

• Establish QC Chemistry and Device Testing start-up capabilities and to support qualification.
• Define KPIs (Compliance, RFT) and drive continuous improvement.
• Author/review technical and compliance documents (test methods, SOPs, validation protocols).
• Own QMS records including investigations, deviations, CAPAs, and changes.

Skills

QC Leadership

Regulatory inspections

Budget management

Cross-functional collaboration

Education

B.S./M.S. in science

Tools

Analytical instruments

Job description

Genentech's Holly Springs site seeks an experienced leader to head QC Chemistry and Device Testing, establishing a start-up laboratory and delivering compliant, efficient testing for CVRM products. You will build a proactive quality culture, implement QMS processes, and partner across global QC networks to ensure regulatory readiness.

You will set KPIs, author methods and protocols, manage budgets, and drive Lean Leadership in a fast-paced, greenfield environment launching in the near term.