PAREXEL International LLC Associate Director, Quality Assurance in United States
Associate Director, Quality Assurance
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Job IDR0000007208 Northeast - Remote - United States of America
When our values align, there's no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
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)
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
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.