Job Purpose
As QA head of WuXi Vaccines Suzhou site shall be responsible to build, maintain and improve the QA team including QMS team, QA Operations team, Online & Release QA team, and Validation team activities. This position shall also be responsible for their performance, competency and capability. The Site QA head shall oversee all QA and QV activities. This position shall report to CQO of Wuxi Vaccines and dotted line report to site head of WuXi Vaccines Suzhou site. The direct reports of this position include all the team leaders of the QA team. The QA Head also shall interact with Head of Global Quality Department from WuXi Biologics to seek guidance and alignment of quality system and practices, and leverage the capability and capacity of the quality team of WuXi Biologics for audit, quality management processes, training.The QA Head shall lead QA and QV team to deliver quality activities and continuously develop new strategies to maximize performance and service levels. This position shall manage personnel, resource and maintain readiness for client’s project and regulatory inspection.
Key roles and responsibilities
Quality assurance management
· Build, maintain and improve the quality system of the Company to meet expectation of and ensure compliance with requirement of relevant regulatory authorities including NMPA, WHO, EMA, FDA and other countries/areas in the scope of the vaccine development and manufacture services provided by the Company
· Lead the activity to develop, monitor, improve and maintain procedures to ensure compliance with GMP (EU/FDA/WHO/NMPA and other appropriate standards) for the manufacture and testing of vaccines
· Manage and report internal
· Lead preparation and hosting of regulatory inspections and client audits
· Manage and report quality review meetings for the Company
· Lead the management and approval of all quality assurance agreements in relation to manufacturing, testing and stability programs
· Lead batch release duties in accordance with relevant procedures for GMP compliance and certification
· Lead the development, implementation and subsequent monitoring of continuous improvement activities
Qualification and validation management
· Guide the Head of QV in goal setting and budgeting, and conduct review of performance of QV team
· Define, execute and improve strategies of qualification and validation on risk and experience-based approach
· Ensure in time and compliant delivery for validation activities
· Lead the technical excellence, operation excellence and GMP compliance
· Lead the continuous GMP quality management level improvement and work
Project management and business development
· Work with Head of Manufacturing and other department heads to ensure safe and efficacious products produced and released
· Interact with external and internal customers and resolve quality issues in timely manner
· Build and train QA functional lead (FL) team to represent QA working with clients
· Work in synergy with other teams of the company to win vaccine CDMO projects for assigned site and other sites of the company
· Coordinate quality internal resource in synergy with other teams for due diligence, gap analysis, planning and execution of new facility project, and ensure timely GMP release of the whole facility
People and operation management
· Provide leadership for all aspects of quality and guidance/direction to subordinates
· Oversee the site quality daily operations
· Develop and build quality team including planning, hiring, coaching/mentoring, and training for staffs and team leaders. Maintain and grow the quality team, and be responsible for the performance, competency and capability of the quality team
· Understand company priorities and allocate internal resources to achieve consistent delivery and team success
· Prepare QA&QV budget and maintain QA&QV operating costs within the approved budget
Education & Work experience
· More than 10 years’ experience in a GMP manufacturing environment supporting or leading quality responsibilities for clinical and commercial vaccines products
· More than 5 years’ people management or project leading experience
· Experience in supporting or leading regulatory inspections
· Experience in assuming delegated role of senior quality management
Proven experience in creating and carrying out successful plans and processes to solve complex problems
Capabilities
Problem Solving and Innovation: The most important or major problem in work
- A variety of non-process problems needed to be analyzed and solved by experience
- Need to analyze to find problems and find solutions through evaluation and judgment
- Define problems through data analysis and understand process for decision-making
- Need thoroughly analysis to find problems, innovatively solve problems without precedent
- Highly complex problems and extensive analysis and modeling are needed for solution
- Challenged problems and the solutions have an impact on the company's strategy
Communication: The degree of cooperation with others and the complexity of communication
- Expound data or material in one's own language
- Need speech or defense analysis
- Need strong persuasiveness
- Strategic negotiation on behalf of the company
- Responsibilities span at least two countries (with complete organizational structure)
- Responsibilities span at least three regions with main countries
Impact: Scope and span of individual impact
- Work under direct guidance / close supervision
- Plan own work but limited to the realization of short-term goals
- Contribute to others' goals
- Develop implementation plans to achieve operational and strategic plans
- Transform strategic plans into operational plans
- Transform vision into strategic plan
- Establish vision and goals
- The results of the work have an immediate impact on the scope of the job
- The results of the work have an immediate impact on team
- The results of the work have an impact on department / sub department
- The results of the work have an impact on key department / company
- The results of the work have an impact on company / company group
Other Requirements:
- Knowledge of FDA, EU, WHO, NMPA and PIC/S GMP requirements
- Knowledge of FDA guidelines for industry and CFRs
- Knowledge of ICH guidelines
- Knowledge and hands on experience in WHO Prequalification at a senior or management level
- Demonstrated leadership role with quality function
- Effective communication and good interpersonal skills
- Flexible and adaptive team player
- Ability to perform multiple tasks effectively in a busy environment
- Ability to lead and support key activities and priorities within a cross-functional team
- Demonstrated skills for problem solving and investigation
- A self-starter, self-motivated, and highly flexible in this position
- Be organized and detailed-oriented