The Senior Director/Director, Quality Assurance will manage the quality assurance department and systems to ensure compliance with Good Clinical Practices (GCP), Good Laboratory Practices (GLP), and current Good Manufacturing Practices (cGMP), oversee the GXP (GCP, GLP, and GMP) vendor qualification program and communicate compliance information to Senior Management.
• Review and ensure implementation of QA SOPs, to support the Preclinical Development, Clinical Development and Pharmaceutical Science GXP functions.
• Perform gap analysis of departmental SOPs for Research and Development departments that support their GXP activities and ensure QA review of all GXP SOPs.
• Oversee QA change control management system for Ardea's GXP activities.
• Ensure the review of vendor GMP documentation (master and executed batch records, CoAs, etc.) prior to drug release for human studies or commercial distribution.
• Oversee the QA team for internal GLP analytical chemistry and bio-analytical studies.
• Promote compliance with GCP, GLP and GMP requirements according to FDA and international regulations and guidelines.
• Ensure adequate support for vendor qualification program and assist QA staff with review and determining appropriate corrective actions.
• Oversee training programs for Ardea staff and contractors for GCP, GLP, and GMP compliance responsibilities and documentation.
• Guide Pharmaceutical Sciences department in the establishment of GMP systems, as needed to support business goals.
• Ensure adequate GMP documentation in house to support regulatory submissions.
• Develop Quality Agreements with GMP vendors for Phase 3 and commercial supply.
• Keep senior management informed of regulatory authority inspections at Ardea or contracted vendors and of potential or known compliance issues at Ardea or contracted vendors.
• Other duties as may be necessary.