Endpoint Clinical is hiring a
Senior Director Quality Management Systems and Technology

Summary

Join Endpoint as a Senior Director of Quality Management Systems and Technology to lead the company's global quality strategy for computer-based Systems and Technology platforms.

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

Responsibilities

• Collaborates with leaders and process owners from all departments to develop and refine the scope and content of the QMS related to computer-based Systems and Technology
• Collaborate with IT to develop an information security and IT risk management program to ensure the integrity, confidentiality, and availability of information
• Provides quality leadership and coordination between teams, and mentors team members to foster an engaged and collaborative approach to quality and compliance
• Defines the auditing and ongoing monitoring processes to ensure CSV, data handling and related practices for both product and study delivery meet the requirements of our QMS and appropriate regulatory expectations
• Participates in process improvement initiatives, ensuring implementation captures both endpoint strategic goals and meets regulatory requirements
• Contributes to the effective hiring, onboarding, training, and coordination of team members to complete or manage the Systems and Technology by providing feedback on the following aspects of the following activities
• Provide input on and participate in Internal, External, and Vendor audit activities to ensure audits are executed in a manner that meets customer/regulatory needs
• Participate in regulatory intelligence activities and ensure that company policies are established and continuously refined
• Provide input during contract review to ensure that applicable technology clauses are defined appropriately
• Act as a consultative partner with regard to product quality via Quality By Design or other process improvement tools
• Participate and provide input during issue management processes, ensuring that procedures are appropriately defined and executed
• Provide Subject Matter Expertise for the qualification of Product Development, Network Infrastructure, and Software tools
• Contributes to Management Reviews with feedback on products and processes with information that drives quality management decisions and refinement of the QMS
• Participates and/or leads efforts relating to Crisis management or breach management
• Provides consultation on Vendor management activities, as they would apply to regulatory requirements, endpoint systems and technology, or the QMS
• Manages identified compliance issues related to areas of responsibility in accordance with Endpoint Clinical processes and procedures, as needed

Benefits

Medical, Dental, Vision, Life, STD/LTD, 401(K), Paid time off (PTO) or Flexible time off (FTO), and Company bonus where applicable