Imp qa manager

Overview

IMPACT Quality Operations Switzerland is responsible for delivering Investigational Medicinal Products (IMPs) in compliance with cGMP guidelines to patients. As a quality partner for all production units and clinical packaging in pharmaceutical development in Switzerland, the role oversees quality and compliance monitoring of all processes and supports production teams to foster an innovative quality culture.

Responsibilities

• Act as primary QA presence on the shop floor, conduct regular inspections of GMP facilities and laboratories, and ensure inspection readiness and real‑time compliance.
• Provide immediate QA support and solution‑oriented advice to manufacturing teams when issues or deviations arise.
• Serve as delegated representative of the Swiss Responsible Person (RP) for IMPs.
• Oversee GMP compliance for manufacturing and analysis of parenteral IMP batches.
• Review and approve GMP procedures, protocols, reports, including SOPs, master batch records, deviation and change control reports, and validation reports.
• Approve project plans and reports related to process design.
• Lead and conduct self‑inspections in GMP operations and laboratories.

Qualifications

• Minimum Bachelor's or Master's degree in Life Sciences or equivalent, with at least 10years of relevant pharmaceutical industry experience focused on cleanroom concepts, aseptic processes, and/or parenteral drug manufacturing.
• Demonstrated experience in shop‑floor quality assurance or a strong background in production/operations with a passion for being present on the production floor.
• Comprehensive knowledge of pharmaceutical technical development and FDA, EMA, ICH regulations and cGMP requirements for clinical development of biotechnological and/or parenteral IMPs, including EU Annex1.
• Strong problem‑solving and decision‑making skills with the ability to make risk‑based QA decisions on site.
• Excellent communication and interpersonal skills to coach and collaborate with production teams; ability to communicate professionally in German and English (written and spoken).

Equal Opportunity Statement

Roche is an Equal Opportunity Employer.