Associate Director, Document Management - Waltham - Ardelyx

    Ardelyx
    Ardelyx Waltham

    1 day ago

    Description

    Associate Director, Document Management

    Ardelyx is a commercial biopharmaceutical company that discovers, develops, and commercializes innovative medicines for unmet medical needs. We have two approved products in the US: IBSRELA (tenapanor) and XPHOZAH (tenapanor). We partner with other companies to develop tenapanor outside of the US.

    This role oversees document management and training systems, including reporting quality metrics and supporting internal audits and inspections. The Associate Director will improve GXP documents and training processes and lead organizational changes.

    • Oversight of GXP document management programs ensuring compliance with regulations,
    • Developing strategic plans for documentation and training,
    • Managing electronic learning systems, 
    • The ideal candidate has 8-10 years of experience in pharmaceutical quality systems, hands-on audit experience, excellent communication skills, and a proven track record leading cross-functional teams.

      Ardelyx offers competitive compensation packages based on industry data, a robust benefits package including employer-matched retirement plan,
      paid parental leave, equity incentives, health insurance,­ flexible time off.

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