Director of QA Validation

The Director of QA Validation, reporting to head of QA Operation is responsible for the oversight, governance, and lifecycle management of validation activities across manufacturing and quality systems, ensuring compliance with regulatory requirements and alignment with biosimilar product standards.

Key Responsibilities

• Provide QA oversight and approval of validation activities, including process validation (PPQ), cleaning validation, analytical method validation, equipment qualification (IQ/OQ/PQ), and computerized system validation (CSV)

• Ensure validation programs comply with GxP, FDA, EMA, and ICH guidelines

• Review and approve validation protocols, reports, risk assessments, and deviation/CAPA records

• Ensure validation strategies are science- and risk-based, aligned with biosimilar products and process complexity

• Support technology transfer, scale-up, and lifecycle validation maintenance

• Lead and maintain the Validation Master Plan (VMP) and ensure inspection readiness

• Partner cross-functionally with R&D, Manufacturing, MSAT, QC, IT, and Engineering to ensure timely execution of validation deliverables

• Drive continuous improvement in validation practices and compliance robustness

Qualifications & Experience

• Bachelor’s or Master’s degree in Life Sciences, Engineering, or related field

• 8+ years of experience in GMP quality/validation, preferably in biologics/biosimilars

• Strong knowledge across process, method, equipment, and computerized system validation

• Experience supporting regulatory inspections and audits

• Demonstrated leadership, decision-making, and stakeholder management skills

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.