Associate Director, Quality Assurance

Home Based, US

The Associate Director, Quality Assurance (QA) is accountable for the formulation and execution of a viable, results-oriented strategy for assigned area related to hosting and support Sponsor Audits and Regulatory Inspections. Responsible for assessing and verifying compliance with GxP standards, consistent with applicable laws, regulations, Parexel policies and procedures, client contracts and procedures, and other standards as may be applicable to particular, situations. Provide leadership and direction to team, possessing vision, technical competence, outstanding communication skills, pragmatism, a bias for action and cooperative approach to problem solving with internal and external clients. Communicate compliance issues to management.

Knowledge and Experience:

• 10 - 12 years’ experience in clinical research and/or experience in ICH -GxP principles
• Demonstrated experience in Quality or Risk Management activities.
• Expertise in root cause methodologies (e.g. 5-whys, fishbone diagram, etc.) and CAPA development
• Expertise in Clinical Trial Risk Management
• Expertise with ICH-GxP principles and clinical trial or non-clinical trial regulations as applicable
• English proficiency (written and oral)

Education:

• Bachelor’s Degree or other relevant experience required. Life-science or other health-related discipline preferred
• Master’s Degree in a science, technology or industry-related discipline preferred