WuXi AppTec Quality Assurance Audit Lead in Philadelphia, Pennsylvania

The primary Audit Lead’s function is to manage and participate in all facets of audits and inspections – client, regulatory, internal, external and vendor/supplier. The position also provides support for the PHL QA and corporate QA operations and management to implement regulatory strategies and ensure regulatory compliance.

  • Manage and conduct site client audits as directed by QA Management, to present overall quality systems and procedures, and handle audit responses in a satisfactory and timely manner.

  • Drive closure of CAPA resulting from audits.

  • Communicate with clients on compliance issues and corrective action surrounding PHL audits.

  • Participate in regulatory and accreditation audits and inspections as directed by QA Management.

  • Manage and conduct internal, external and vendor/supplier audits as directed by QA Management.

  • Participate in the development of site and corporate compliance policies, procedures and documents.

  • Assume a contributing role in compliance projects and participate in corporate and site strategic meetings.

  • Maintain knowledge of WuXi policies, procedures and directives as well as US and international regulations and guidelines associated with PHL services.

  • Performs other duties as required.

  • Participate in cross-site projects.

  • Provides back-up for the QA department in selected areas as needed.

  • Travels as required by the company

  • Thorough working knowledge of Regulatory Compliance, Quality System Management and Quality Assurance principles and practices.

  • Knowledge of FDA GLP/ cGMP requirements, FDA PTC guidelines required.

  • Knowledge of EU cGMPs highly desirable.

  • Ability to write and revise documents. Ability to use judgment in situations for which there are no precedents.

  • Experience in GLP and GMP.

  • Bachelors Degree or equivalent.

We are an Equal Opportunity Employer. Minorities/Women/Veterans/Disabled.

Job ID: 2017-3012

External Company Name: WuXi AppTec Inc

External Company URL: http://wuxiapptec.com