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Sr. Medical Writer

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$145,000 - $170,000
Job Type
Direct Hire
May 02, 2016
Job ID
Job Summary

Head the Quality function at Akebia.  Responsible for the development, implementation, and administration of the Quality Management System (QMS) including activities, personnel, systems, procedures, and programs to provide assurance to management and stakeholders of the quality, reliability, and compliance of the organization and data outputs. Activities include management and oversight of product development, testing, stability, validation data, documentation, and records relating to the manufacturing, sampling, testing, analysis, and investigation of clinical and commercial drug materials manufactured by or for the company.  Reports to the Vice President of Regulatory Affairs.
Essential Functions and Duties
  • Manage the Quality Organization.
  • Develop, implement, and administer the Quality Management System (QA Manual and other Controlled Documents, including Standard Operating Procedures, Forms, Templates, Policies, etc.).
  • Develop, direct, and/or oversee QA activities and programs for internal and third party supplier operations that are subject to GXP regulations and guidelines; establish QA Agreements, as needed.
  • Provide QA oversight of drug substance and drug product contract manufacturers and contract test labs.  Perform audits. Responsible for disposition of clinical materials used in human clinical trials.
  • Provide expert technical analysis and evaluation of quality assurance issues affecting corporate projects, establish risk mitigation and best practice strategy for resolution.
  • Direct all Corrective Action/Preventative Action (CAPA) investigations, investigate suspicions of Fraud and or Misconduct, and Serious Breach Reporting where required.
  • Facilitate audit requests including due diligence visits.
  • Lead inspections by Regulatory Authorities.  Support preparation of clinical trial sites, contract manufacturers, and nonclinical testing laboratories for Pre Approval Inspections (PAI) by Regulatory Authorities.
  • Consult with and provide regulatory training (GCP, GLP, GMP) to company departments on a regular basis.
  • Participate on project teams and/or working groups, as required.
  • Develop, manage, and ensure effective implementation of corporate audit plan.
Skills and Experience
  • Bachelor’s degree in a scientific discipline such as chemistry, biology, microbiology or similar required.  Advanced or doctorate degree in a scientific discipline preferred.
  • Minimum of 3 years in Director of Quality Assurance or higher position within the pharmaceutical/biotech industries.
  • Minimum of 8 years of experience in a FDA-regulated pharmaceutical environment performing QA functions, with a minimum of 1-3 years in a supervisory QMS management capacity, in a GXP pharmaceutical environment. Comprehensive knowledge of quality principles and cGMP, GLP, and GCP regulations.
  • Experience leading Regulatory Authority Inspections required.
  • Strong interpersonal skills; the ability to interact effectively with all levels within the organization, third parties, and regulatory authorities.
  • Excellent project management and decision-making skills.
  • Experience in commercial drug product release and commercial launches preferred.