Global Quality Lead - Pharma Development & Compliance

F. Hoffmann-La Roche AG

South San Francisco (CA)

On-site

USD 111,000 - 206,000

Full time

3 days ago

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Benefits offered by this job

Discretionary annual bonus

Benefits package

Job summary

Genentech, a Roche subsidiary in South San Francisco, seeks a Quality Lead for the Pharma Development Quality (PDQ) division to develop and deliver robust QA strategies, audits, and regulatory conclusions across molecules in development and post-approval products. You will lead audits, collaborate with international stakeholders, and support regulatory inspections using a CtQ framework.

The role requires BS in science/quality, strong GxP knowledge, data analytics skills, and excellent

Qualifications

Bachelor’s degree or equivalent in a scientific or quality-related field.
Experience in pharmaceutical, biotech, or medical device industries.
Strong global GxP knowledge across GCP, GVP, or IVD/MD frameworks.
Proficient analytical and data-driven decision making.
Excellent communication and stakeholder management skills.

Responsibilities

Develop and deliver robust QA strategies and conclusions across development and post-approval products.
Lead audits, identify trends, and provide regulatory-compliance data.
Collaborate with international stakeholders to support inspections.
Support regulatory authority inspections readiness and management.
Drive continuous improvement of PDQ processes and GxP frameworks.