Senior Director - Quality Management Systems and Technology

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Endpoint Clinical

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Interactive Response Technology (IRT) systems and solutions provider supporting the life sciences industry.

IVR/IWR for clinical trials • IRT • Randomization • Clinical Supply Chain Management • ePRO

501 - 1000

💰 $1.7M Debt Financing on 2010-03

Description

• About Us: • Endpoint is an interactive response technology (IRT®) systems and solutions provider supporting the life sciences industry. • Since 2009, we help sponsors and pharmaceutical companies achieve clinical trial success. • Our solutions, realized through the proprietary PULSE® platform, maximize the supply chain, minimize operational costs, and ensure timely and accurate patient dosing. • The Senior Director leads Endpoint’s global quality strategy for computer-based Systems and Technology platforms. • This position ensures Computer System Validation (CSV), data handling, and practices meet Quality Management System (QMS) expectations. • The role promotes quality improvement by championing a company culture of quality. • This position reports to the VP, Quality.

Requirements

• Bachelor's degree preferred. • Master's degree in Clinical Science, Computer Science, or Engineering is a plus. • Certification in Quality Assurance (e.g. CQE or CSQE), Computer Systems, or Regulatory Affairs is preferred. • Experience within a regulated environment demonstrating leadership progression. • Experience working or managing in GXP environment with software or electronic systems (21 CFR Part 11, EU Annex 11). • Strong working knowledge of quality management system tools and software (e.g. DMS, LMS, eQMS). • Knowledge of U.S. and international regulatory standards and guidelines for management systems (e.g. ISO 9001, 13485, 27001) a plus. • Knowledge of cQMS is highly preferred. • Relevant experience in the clinical trial industry, IRT, or CRO experience is highly desired. • Proven successful supervisory experience, including managing managers, is necessary.

Benefits

• All job offers will be based on a candidate’s location, skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data. • Regular, full-time or part-time employees working 30 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(K), Paid time off (PTO) or Flexible time off (FTO), and Company bonus where applicable.