WuXi AppTec

  • Director of Manufacturing Compliance at Wuxi Manufacturing Site

    Job Locations CN-Shanghai
    Job ID
    2018-4260
  • Overview

    • Take part in the establishing of the Manufacturing Compliance team and daily operation of the team as site team leader and assistant to the Head of Manufacturing Compliance
    • Support Biomanufacturing operations at Wuxi Manufacturing Site with a focus on GMP compliance in every aspects of manufacturing operations for existing and new facilities/sites
    • Ensure the development and operations of manufacturing facilities at Wuxi Manufacturing Site comply with cGMP requirements
    • Ensures Site Management is well informed on state of GMP compliance of all GMP manufacturing facilities, existing and in development
    • Support global expansion of Biomanufacturing network and the growth of Manufacturing Compliance core team and matrix at other site

    Responsibilities

    ESSENTIAL DUTIES AND Responsibilities

    • Support manufacturing operations at Wuxi site with a focus on GMP compliance in every aspects of manufacturing operations for existing and new facilities/sites
      • Advise manufacturing senior management regarding GMP appropriateness of management decisions to be made or made
      • Evaluate key decisions made or to be made by each teams within manufacturing to ensure appropriateness in GMP compliance. Alert / escalate to senior management to take corrective action to avoid risks in future regulatory decision/inspection
      • Monitor and support the whole life cycle of new facility development, with a focus on GMP compliance, including change control, SIA, Engineering Run readiness, GMP run readiness in terms of facility, equipment, documents, training and qualification, and regulatory/client QA/QP GMP inspection/audits
      • Monitor and report the GMP compliance performance of each team within manufacturing organization. Alert and advise management and team leaders if there is adverse trend or serious issue in status of GMP compliance.
      • Represent manufacturing to work with QA, client and regulatory agencies for GMP compliance, audit, inspection and communications
      • Work with Supply Chain Management, WuXi Biologics Operations, Finance, Government Affairs, CEO office, and HR to ensure smooth and GMP compliant manufacturing operations
    • Ensures Management is well informed on state of GMP compliance of all GMP manufacturing facilities, including but not limited to trending of deviations, competency of each team/facility in complying with cGMP and bench marking with industry best practice, rating of appropriateness of change control for new facility/renovation/assess management/supply chain management, appropriateness of CAPA, acceptance rate of regulatory/audit response.
    • Support the expansion global expansion of Biomanufacturing network, with a focus on GMP compliance, competency and appropriateness of facility development in complying with regulatory expectation/trends and industry trends.
    • Host visitors/inspection from various government agencies and clients on behalf of manufacturing

    OTHER DUTIES AND responsibilities

    • Lead GMP related tasks assigned by supervisor.

    Qualifications

    KNOWLEDGE SKILLS AND Abilities

    • Bachelor and above degree in pharmaceutics, biology, engineering, business administration
    • More than 10-15 years of GMP related experiences and/or management in pharmaceutical and biopharmaceutical industry
    • Good knowledge and experience in GMP environment and working within Quality System
    • Good communications skill
    • Fluent in written and verbal English and Chinese

    WORKING CONDITIONS

    Location: Wuxi, CN then Worcester, MA

    Need to travel to facilities of the Biomanufacturing organization

    Direct reports: team members of the core teams of Manufacturing Compliance at Wuxi site

    Dotted line reports: team leaders of the matrix teams of Manufacturing Compliance, for example, the team leader of GMP compliance of a certain DS manufacturing facility at Wuxi site

     

    Equal Opportunity Employer Minorities/Women/Veterans/Disabled

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