To provide strategic and technical leadership for Zhejiang site in all Quality System related matters and to ensure that all aspects of the operational business comply with cGMP and regulatory requirements and the applicable AH Quality Manual requirements.
Ensure alignment of owned quality systems with the intent of the AH Quality Manual, and where required, develop and document rationale for differences between local requirement and Quality Manual core requirement.
Ensure that Quality Systems and Standard Operating Procedures are in place and that compliance with cGMP’s is maintained through training and auditing.
Ensure that change control requests are processed, reviewed and approved in a timely manner. Ensure that the documentation of the change records are complete and closed within the time limits established by the V&D Global Quality Organization
Ensure that deviation, CAPA and complaint are processed, reviewed and approved in a timely manner. Ensure that the documentation of the deviation and CAPA are complete and closed within the time limits.
Ensure that Data integrity project is processed and complete within the time limits established.
Responsible for the change control review board meetings and for ensuring the change control coordinator may effectively fulfil the duties of that function
Ensure the Training program is maintained, an annual training plan is developed and approved before the end of January, and is executed as defined
Ensure training records are generated and maintained in compliance with applicable regulations.
Ensure documentation related to GMP operations is managed and archived per AH Quality Manual requirements
Ensure management of suppliers and GMP service providers comply with cGMP and AH Quality Manual requirements.
Manage external audits, self-inspections, and health authority inspections.
Provide leadership, direction, and support to the people within the QS department and ensure that they are qualified, achieve a high level of competence, are motivated, and carry out their duties in a safe manner.
Acquire and maintain knowledge of current local and international regulatory and legislative requirements and trends to ensure that expert advice and appropriate technical support on all quality systems related matters is provided to the whole site.
Together with the Head of Quality for the manufacturing site, provide direction and assist with formulating strategies and making decisions that ensure the efficient operation of the business as a whole.
Ensure that any product quality / supply issues are communicated timely to management as required and are remediated appropriately
Lead, promote, integrate and monitor the implementation and maintenance of Safety, Health and Environmental (EHS) management.
Actively develop talent within the organization through mentoring and development programs
Direct Leadership of Quality Assurance Department with its relevant responsibilities e.g.
Bachelor degree in Chemistry, Pharmacy, Biology, Chemical Engineering or related science discipline.
Advanced degree desirable.
Minimum 8 years’ experience in the Pharmaceutical Industry with a Quality Assurance Role.
Possess demonstrated interpersonal skills, including leadership, coaching and development, performance management, motivation, communications and negotiations.
Experience in site based manufacturing or quality operations in managerial roles.
Strong knowledge and understanding of cGMP regulations, guidelines and expectations and their application in daily operations.
Strong analytical and problem solving skills,
Ability to make decisions in a constantly changing environment.
Chinese Language skills, verbally and in writing
Professional English Language skills verbally and in writing
Proficient in technical writing and current computer usage