QA Investigations Manager

The QA Investigations Manager, reporting to product quality and quality events manager, leads the investigation function within Product Quality and Quality Events, overseeing a team of lead investigators responsible for managing deviations, product quality complaints (PQC), and OOS investigations to ensure timely, compliant, and high-quality outcomes. 

Key Responsibilities

• Lead and develop a team of investigators handling deviations, PQCs, and OOS events 

• Ensure investigations are thorough, timely, and compliant with GxP and regulatory expectations 

• Drive robust root cause analysis and ensure effective, science- and risk-based CAPAs 

• Oversee intake, triage, prioritization, and escalation of quality events 

• Ensure consistency and quality across investigations, including narrative clarity and technical rigor 

• Monitor KPIs (cycle time, recurrence, effectiveness) and drive continuous improvement 

• Collaborate cross-functionally with QC, Manufacturing, MSAT, and Regulatory 

• Support inspections and audits, acting as process SME for investigations and complaints 

• Maintain procedures and ensure alignment with global regulatory expectations 

Qualifications & Experience

• Degree in Life Sciences or related field 

• 5+ years in GMP quality, with significant experience in investigations and root cause analysis 

• Strong leadership and people management experience 

• Deep understanding of deviations, PQC, and OOS processes in biologics/biosimilars 

What we offer:

• An inspiring challenge to work with great co-workers on ambitious projects that change people's lives.

• The chance to be a part of a global and fast-growing company.

• An international work culture that encourages diversity, collaboration, and inclusion.

• Positive, flexible, and innovative work environment.

• Support for personal growth and internal career development.

• Company social events and milestone celebrations.

• Excellent in-house canteen and coffee house.

• Exercise and well-being support for full-time employees.

• On-site shower facility.

• Transportation grant towards eco-friendly modes of travel for full-time employees.

• Internet at home for full-time employees.