Director, Analytical Sciences & Technology – QC Excellence

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

Benefits offered by this job

Relocation assistance

Discretionary annual bonus (based on/;

Job summary

Genentech is launching a greenfield drug product manufacturing site in Holly Springs, NC, seeking an experienced leader for Analytical Sciences and Technology to build an effective QC organization for CVRM products.

You will establish QC methods, drive KPI-focused performance, manage QMS records, and collaborate with global partners to ensure regulatory compliance and continuous improvement throughout the lifecycle of the facility.

Qualifications

• Minimum of 8 years of experience in pharmaceutical/biopharmaceutical manufacturing, including at least 3 years in QC operations at a finished drug product site.
• Extensive knowledge of analytical methods, laboratory instrumentation, and method validation/transfer.
• Strong understanding of cGMP, ICH guidelines, and global regulatory requirements (FDA, EMA).

Responsibilities

• Establish QC methods to support facility start-up, qualifications, and ongoing QC operations.
• Own QMS records, investigations, deviations, CAPAs, and change controls.
• Present QC topics during regulatory inspections and maintain audit readiness.
• Lead and develop a high-performing QC team and align with the global QC network.

Skills

Quality leadership

Regulatory knowledge

Project management

Communication

Analytical methods

cGMP knowledge

QC operations

Deviation investigations

Team coaching

Education

B.S./M.S. in science

Tools

Analytical instrumentation

LIMS/Instrumentation

Job description

Genentech is launching a greenfield drug product manufacturing site in Holly Springs, NC, seeking an experienced leader for Analytical Sciences and Technology to build an effective QC organization for CVRM products.

You will establish QC methods, drive KPI-focused performance, manage QMS records, and collaborate with global partners to ensure regulatory compliance and continuous improvement throughout the lifecycle of the facility.