Head of Q&V and Digitalization Quality

• Oversee and guide the technical strategy and direction of validation activities for PT Shanghai in the preparation and execution of validation protocols, including facility, utilities, equipment, cleaning, and computer system validation.
• Review and approve site Validation Master Plan (VMP)/project plans and ensure the strategy meets business and regulatory requirements. As needed, review/approve validation protocols, engineering change orders, Standard Operation Procedures (SOP), engineering commissioning and turnover packages.
• Provide input and review for site-specific and corporate validation procedures and shared practices as applicable and in accordance with the requirements set forth in the governing quality standards in partnership with Global Quality.
• Oversee and guide execution of the validation of tech transfer oversight, new facility expansions and construction projects.
• Review and approve all relevant Quality Validation and other Site documentation and ensure documentation supports a compliant state.
• Provide expert interpretation and application of regulatory guidelines to ensure operations, facilities and documentation meet Roche standards and regulatory requirements.
• ensuring that the department ensures quality oversight of the qualification and validation processes. This applies across the entire lifecycle of the processes and equipment. This includes:
• Plant qualification of production equipment and the entire infrastructure (pharmaceutical water, HVAC, process gases).
• Validation of production, cleaning and transport processes
• Validation of computer systems and software (CSV), including ensuring current data integrity requirements.
• Oversight of product and process transfers from or to other locations and partners
• Other activities assigned.

• Establish and lead a competitive team to ensure the delivery and good performance through strong team work and shared responsibilities
• Create an environment of strong team spirit, timely and effective communications, sense of urgency, high motivation and inspire teams to achieve goals in the immediate and longer term. Be an active and visible change agent, promoting flexible and open mindsets to new opportunities.
• As a leader within the Quality Leadership team, drive network activities and alignment, cross-functional planning, and decision making.

• Bachelor Degree or above (Pharmacy, Pharmaceutical, bioengineering, Chemistry or other relevant discipline is preferred).

• Leads by example
• Strong leadership, teamwork and management skills
• Ability to effectively communicate and influence across all levels of the organization
• Good accountability of problem solving
• Empower and trust people to make decisions
• Discover and develop the potential in people

• 10 or more years' work experience in the pharmaceutical or related industry
• 3 or more years' people management experience
• 5 or more years' experience in a commercially licensed GMP facility

• Expert knowledge of Quality System, Quality Validation and QA principles, practices and standards for the pharmaceutical industry.
• Strong knowledge of pharmaceutical, biotechnology or medical device related product operations including local and international quality regulations.

• Able to think strategically and translate strategies into actionable plans.

• Takes responsibility, drives results, and achieves expected outcomes.

• Possesses strong verbal and written communication skills in both English and Chinese, and the ability to influence at all levels.

• Build trustful and effective collaboration relationships.

Roche