Head of MSAT Qualification & Validation

The Position

As a leader in the MSAT organization, you will be responsible for driving strategic initiatives, managing high-performing teams, and ensuring operational excellence in qualification and validation (Q&V) processes. You will play a critical role in the design, construction, and startup of new facilities, ensuring compliance with cGMP standards and fostering a culture of innovation and safety.

Responsibilities

• Lead and develop a high-performing Q&V team, fostering a culture of technical rigor, innovation, and cross-functional collaboration.
• Provide strategic leadership aligned with the VACC model, eliminating barriers and enabling team members to reach their peak potential.
• Oversee the design, construction, and qualification of new facilities, including IOPQ, APS, and process/cleaning validation.
• Serve as a technical Subject Matter Expert (SME) for qualification, validation, and manufacturing support.
• Ensure all Q&V activities comply with cGMP requirements, Roche standards, and global regulatory expectations (NMPA, FDA, EMA).
• Drive continuous improvement and operational excellence through lean leadership principles and data-driven innovation.
• Collaborate with global teams to integrate cutting-edge technologies and facilitate seamless technology transfers.
• Manage site SHE procedures and foster a proactive safety culture.
• Mentor and coach team members, building a strong talent pipeline and succession plans.

Requirements

• Bachelor’s degree or higher in Pharmaceutical or Biological sciences.
• Over 10 years of MSAT experience in the injection pharmaceutical industry, preferably in MNC Bio-pharma.
• At least 5 years of hands-on experience in Qualification and Validation.
• Minimum of 5 years of people management experience with a proven track record of team development.
• Extensive experience in strategic projects for Aseptic Filling facilities, including design, commissioning, and qualification.
• Strong expertise in new facility startup readiness and operational ramp-up.
• Deep knowledge of cGMP and biological industry regulations.
• Strategic thinking skills with proficiency in agile methodologies.
• Fluent communication skills in English.