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Associate Director, Research QA

Company: Akebia Therapeutics, Inc.
Location: Cambridge
Posted on: April 5, 2021

Job Description:

Akebia is seeking an Associate Director Research--QA. This role is suited to candidates who possess strong leadership skills and strategic thinking. Utilizing expert Good Clinical and Good Laboratory Practices this role will be a trusted business partner effectively communicating and collaborating with senior stakeholders and leadership teams across the global organization. You will be a part of an expert team supporting global clinical development and post-marketing programs including a special emphasis on pediatric trials. Required Skills

  • Manage the Akebia clinical and nonclinical audit and compliance programs, including internal process and external vendor audits
  • Manage and/or lead diverse & specialized types of audits or projects involving multiple sites, commercial products and/or therapeutic areas.
  • Liaises with key clinical and nonclinical management and other internal stakeholders to execute compliance activities on multiple programs
  • Represent RQA on teams and related Working Groups and quality governance forums as appropriate
  • Investigate and facilitate reporting of critical compliance issues
  • Support CAPA development and perform effectiveness checks of CAPAs as required
  • Deliver end-to-end regulatory inspection strategy and management, which includes facilitation of regulatory agency inspections and partner audits
  • Support regulatory agency inspections as needed
  • Fosters a commitment to quality in individuals and a culture of quality within the organization.
  • Provides expert, timely and risk-based guidance in line with regulations & business needs
  • Qualify, and establish agreements with contract auditors
  • Direct contract auditors and others who oversee activities performed by contract auditors.
  • Evaluate departmental and business area SOPs for fitness for purpose and for compliance with regulatory requirements
  • Provide Quality & Compliance input on new and often complex processes requiring an understanding of complicated cross-functional relationships.
  • Ensure adherence to departmental SOPs
  • Lead intra or interdepartmental teams of an operational nature such as preparing the Company for minor changes in regulations, continuous improvement initiatives etc.
  • Provide leadership, direction, and mentorship to direct reports. Required Experience Basic Qualifications:
    • BA or BS
    • 8+ years of experience in the pharmaceutical industry
    • GCP and GLP audit and compliance experience Preferred Qualifications:
      • MS Preferred
      • GVP audit and compliance experience
      • Recognized as an expert resource on a range of clinical compliance topics.
      • Strong verbal and written communication skills and interpersonal skills.
      • Proficient in Microsoft Office suite. Experience with audit management/CAPA management programs strongly preferred.
      • Excellent organization skills and project management.
      • Able to work equally well as part of a team or independently
      • Ability to travel approximately 25% required. Akebia Therapeutics, Inc. is a fully integrated biopharmaceutical company focused on the development and commercialization of therapeutics for people living with kidney disease. The Company was founded in 2007 and is headquartered in Cambridge, Massachusetts. For more information, please visit our website at--www.akebia.com . Akebia is an equal opportunity employer and welcomes all job applicants. All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.

Keywords: Akebia Therapeutics, Inc., Cambridge , Associate Director, Research QA, Executive , Cambridge, Massachusetts

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