Director, Quality Assurance : Suzhou Biosafety Testing
Responsible for establishing and managing a Quality Assurance Unit for a new Biosafety Laboratory to be built in Suzhou, China. The Testing labs will focus on testing and release assays for cell lines and products, as well as specialized testing programs like viral clearance for a variety of biopharmaceuticals. Position will first be responsible for transferring the processes utilized at the Philadelphia site in the QA department to be utilized in Suzhou. Position will be responsible for the administration, reporting, process creation, and optimization of all Quality processes, while ensuring accordance with current regulations in China as well as meeting US, EMA, and other international regulations, as needed for the company’s clients.
The individual will be responsible for guiding and ensuring adherence to the following quality processes: Deviation / Nonconformance, CAPA, Change Control, Customer Audits, Training, Quality Agreements, Recalls and Compliance reviews. Duties include effectively interacting with Testing, Manufacturing (at Wuxi City site for Biologics), Project Management and Quality Assurance (QA) personnel in order to deliver superior customer service; as well as also interacting with the other WuXi AppTec services in China and the US. Prepares and develops changes in procedures to keep QA current with regard to the practice of all appropriate cGMP, GLP, International Conference on Harmonisation (ICH) regulations, and when appropriate the US Code of Federal Regulations (CFR), Points to Consider (PTC) and other relevant foreign regulatory guidelines for biopharmaceuticals.
- As QA Director, leads the department in development, implementation, and execution of the Quality Assurance program. This program consists of establishing / maintaining policies, guidance, standards, and processes assuring the collection and distribution of applicable quality metric data for the Suzhou site.
- The individual will be responsible for ensuring adherence to Good Manufacturing Practices (cGMP and Good Laboratory Practices (GLP) and other as necessary for Laboratory Studies.
- Establishes and routinely re-evaluates site’s Quality processes to assure compliance with standards set forth in WuXi AppTec’s policy and guidance documents.
- Hires, supervises, plans and reviews operations for Quality Assurance staff, including responsibility for training, managing and evaluating as well as coordinating, scheduling and assigning work and maintaining standards.
- Make decisions on hiring / transferring / promoting / discharging and salary changes and acts on employee problems.
- Conducts employee performance appraisals in a timely and objective manner.
- Provides overall expertise in the field of Quality Systems within a regulated environment.
- Develops and maintains Quality organization budget and capital investment program.
- Participates in client audits as a company spokesperson and presents overall Quality Systems and policies.
- Responds to audit findings in a timely manner.
- Participates in audits by regulatory authorities (e.g. SFDA, FDA, EPA, etc.).
- Works, as part of a team, to exhibit effective interpersonal skills in working with colleagues throughout the company to encourage cooperation, train and implement Quality Systems.
- Interfaces with company’s internal departments, clients, SFDA and other appropriate regulatory officials on QA / regulatory matters.
- Works with Supervisor and Management Team to design company’s Quality Systems.
- Leads and participates in Quality Systems reporting forums assessing compliance with cGMP and other applicable regulations.
- Familiar and comfortable with both English and Chinese languages
- BA/BS (or a more advanced degree) in a Science related major with 12 or more years related experience – which must include at least 7 to 10 years quality assurance ( GXP experience and 10 or more years’ managing personnel - or equivalent training/ experience.
- Knowledge of Chinese, EU, United States and international regulations for biologics.
- Knowledge of cGMP requirements and PTC guidelines is required.
- Ability to use judgment in situations for which there are no precedents.
- Ability to write and revise documents and to evaluate technical data.
- Ability to accomplish the described duties through the use of appropriate computer equipment and software (especially Microsoft Word, Excel, and Outlook).
- Must be proficient in multitasking and time management.
- Ability to work effectively as part of a team and to exhibit effective interpersonal skills.
- Ability to receive and comprehend and to effectively communicate detailed information through verbal and written communication.
- Ability to accurately and reproducibly perform basic arithmetic calculations and statistics.
- Ability to use judgment as dictated by complexity of situation.