Genentech · 1 week ago
QA Technical Operations Lead - Philadelphia
Philadelphia, PA
Full-time
Onsite
Mid, Senior Level
$115K/yr - $213K/yr
5+ years expGenentech is committed to advancing science and ensuring access to healthcare. The QA Technical Operations Lead plays a crucial role in providing Quality Assurance oversight for GMP manufacturing processes and lifecycle management, ensuring compliance with the Quality Management System and driving continuous process improvements.
BiotechnologyLife ScienceManufacturing
Responsibilities
Providing Quality Assurance oversight for the implementation and lifecycle management of GMP manufacturing processes, equipment, facilities, utilities and computerized systems
Supporting the QA oversight for qualification and startup activities for large capital projects
Ensuring compliance with the Quality Management System by representing QA in the facilitation and closure of Change Controls, Deviations, investigations, CAPAs and Risk Assessments
Reviewing and approving system lifecycle documentation for GMP equipment, facilities, utilities, and analytical instruments
Taking a lead role driving continuous process improvements and leading individual quality initiatives
Providing oversight and guidance to project-based Quality Assurance contractors
Qualification
Required
You hold a Bachelor's degree in Biology, Chemistry, Engineering or related life sciences and generally 5-12+ years of experience in the Pharmaceutical/Biotechnology industry
You have robust experience performing QA oversight in a GMP environment
You have advanced GMP process and equipment experience and knowledge of requirements related to biologic drug substance manufacturing
You have in-depth knowledge of global regulations including 21 CFR Part 11, 210 and 211, Eudralex Volume 4, Part IV, relevant USP and ICH guidelines and Data Integrity requirements
You are characterized by a high level of social competence, a competent independent decision maker and are able to accurately record and efficiently communicate in English
Preferred
You have experience in rAAV Gene Therapy manufacturing
You have performed in a QA role (or similar) during startup and qualification of a new GMP manufacturing facility
You are well known for your motivation as well as your independent, yet collaborative working style
Benefits
A discretionary annual bonus may be available based on individual and Company performance.
This position also qualifies for the benefits detailed at the link provided below.
Company
Genentech
Genentech is a biotechnology research company that specializes in genetic testing and personalized medicines.
10001+ employees
H1B Sponsorship
Genentech has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (167)
2024 (148)
2023 (150)
2022 (178)
2021 (121)
2020 (158)
Funding
Current Stage
Public CompanyTotal Funding
unknown2009-03-26Acquired
1999-07-20IPO
1976-01-01Series Unknown
Leadership Team
Ashley Magargee
Chief Executive Officer
Michael Laird
Vice President, Global MSAT Drug Substance Biologics Technology and Commercial Products Support
Recent News
Labiotech UG
2026-01-17
2026-01-16
Company data provided by crunchbase