Sr Director, R&D Quality

* Bachelor’s degree with 12+ years;
Master’s degree with 10+ years; or PhD with 8+ years of R&D quality assurance compliance experience
* Clinical Quality Assurance/Compliance experience in a Bio-pharma sponsor organization required.
* Proven experience in managing compliance programs required.
* Experience in implementing principles for Quality Risk Management (ICH Q9, ICH E6 R3) required
* Familiarity with GVP and 21 CFR Part 11 electronic systems and compliance activities is preferred.
* Experience leading business process improvement projects required.
* Proven effective verbal, written, interpersonal skills to include delivering presentations to executives.
* Recognized as an expert resource on a range of compliance topics.
* Management of junior and senior staff.
* Proficient in Microsoft Office suite.
* Experience with Inspection and Audit management/CAPA management programs strongly preferred.
* Excellent organizational and project management skills.
* Able to lead and mentor effective cross functional teams.
* Ability to travel is approximately 20% required.
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