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Associate Director, Global GxP Audit Lead-Quality

We're looking for a candidate to fill this position in an exciting company.

Ownership of the Internal, External, and Supplier GxP audit programs.
Management of all activities related to the successful operation of the GxP audit programs, including development, implementation and maintenance of Quality System procedures and documentation.
Lead or participate in audits of vendors to evaluate processes, systems and procedures for compliance to GxP requirements and Alexion Quality standards.
Define audit schedules, assign responsibilities to audit team members, and provides audit preparation materials, instructions and training as appropriate.
Assembles audit teams with appropriate skills and experience and ensures audits of internal departments and external vendors are performed according to approved audit schedule.
Coordinates completion of internal audits of Alexion to assess compliance to international GxP requirements and Alexion Quality standards. May conduct audits to assess inspection readiness of Alexion and vendors
Coordinates and reviews audits of Alexion GxP suppliers to assess compliance to international GxP requirements and Alexion Quality standards
Ensures timely issuance of audit reports and follow-up on responses and corrective actions. Tracks completion of activities from scheduling through to audit closure.

7-10 years' experience in Quality Assurance role, of which at least 4 years must be in an Audit or Compliance related role
Experience auditing in a regulated environment is essential
Demonstrable project management skills; experience working in cross-functional teams.
Strong Business Partner with a focus on collaboration and delivering results.
Thorough knowledge of international GxP regulations and standards; expert knowledge of GVP, government regulations and guidelines (EMA, FDA, PMDA) desirable
Travel approx. 30%.