QA Technical Operations Lead - Philadelphia

Genentech • Philadelphia, PA

17h

About The Position

A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That’s what makes us Roche. The QA Technical Operations Lead - Philadelphia, is part of the Pharma Technical Cell & Gene Therapy division which drives and realizes cell and gene therapies by translating scientific progress into life-changing experiences for patients. This role is part of a dynamic team that plays a vital part in this mission. The Opportunity: As an integral part of the QA Technical Operations team your main focus will be providing Quality Assurance oversight for the implementation and lifecycle management of GMP manufacturing processes, equipment, facilities, utilities and computerized systems. 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 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.

Requirements

• 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.

Nice To Haves

• 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.

Responsibilities

• providing Quality Assurance oversight for the implementation and lifecycle management of GMP manufacturing processes, equipment, facilities, utilities and computerized systems
• support the QA oversight for qualification and startup activities for large capital projects
• ensure compliance with the Quality Management System by representing QA in the facilitation and closure of Change Controls, Deviations, investigations, CAPAs and Risk Assessments
• review and approve system lifecycle documentation for GMP equipment, facilities, utilities, and analytical instruments
• take a lead role driving continuous process improvements and lead individual quality initiatives
• provide oversight and guidance to project-based Quality Assurance contractors

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees