Roche · 1 day ago
QA Technical Operations Lead - Philadelphia
Philadelphia
Full-time
Onsite
Mid, Senior Level
$115K/yr - $213K/yr
5+ years expRoche is a leading company focused on advancing science and healthcare. The QA Technical Operations Lead will provide Quality Assurance oversight for GMP manufacturing processes and ensure compliance with the Quality Management System while driving continuous process improvements.
BiotechnologyHealth CareHealth DiagnosticsOncologyPharmaceuticalPrecision Medicine
Responsibilities
You will support the QA oversight for qualification and startup activities for large capital projects
You will ensure compliance with the Quality Management System by representing QA in the facilitation and closure of Change Controls, Deviations, investigations, CAPAs and Risk Assessments
You will review and approve system lifecycle documentation for GMP equipment, facilities, utilities, and analytical instruments
You will take a lead role driving continuous process improvements and lead individual quality initiatives
You will provide 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
Roche
Roche is a pharmaceutical and diagnostics company that offers medicines and diagnostic tests for various medical conditions and diseases.
10001+ employees
H1B Sponsorship
Roche 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 (12)
2024 (9)
2023 (6)
2022 (2)
2021 (2)
Funding
Current Stage
Public CompanyTotal Funding
$7.79BKey Investors
SoftBankSCALE AINovartis
2021-08-04Post Ipo Equity· $5B
2020-12-07IPO
2020-05-06Post Ipo Equity· $0.5M
Leadership Team
Alan Hippe
Member of the Executive Board - Group CFO
Christine Bakan
Global Head and VP of Software and Bioinformatics, Next Generation Sequencing
Recent News
2026-01-09
2026-01-07
Company data provided by crunchbase