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. #J-18808-Ljbffr