Senior Director, Quality Management Systems and Technology

About Us:

Endpoint is an interactive response technology (IRT®) systems and solutions provider that supports the life sciences industry. Since 2009, we have been working with a single vision in mind, to help sponsors and pharmaceutical companies achieve clinical trial success. Our solutions, realized through the proprietary PULSE® platform, have proven to maximize the supply chain, minimize operational costs, and ensure timely and accurate patient dosing. Endpoint is headquartered in Wakefield, Massachusetts with offices across the United States, Europe, and Asia.

Position Overview:

The Senior Director, Quality Management Systems and Technology leads Endpoint’s global quality strategy for computer-based Systems and Technology platforms. This position ensures that Computer System Validation (CSV), data handling, and related practices for both product and study delivery meet the requirements of our Quality Management System (QMS) and appropriate regulatory expectations. The role promotes quality improvement by championing a company culture of quality.

This position reports to the VP, Quality.

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.
• Provides guidance on applicable regulations and standards, as well as suitable interpretations for the organization’s goals.
• 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.
• Key stakeholder, contributor, and subject matter expert in Systems and Technology QMS procedures, ensuring consistent implementation across departments. Provides QTC review and approval of procedures, templates, and deviations related to areas of responsibility.
• Hosts or participates in department leadership meetings and/or workshops on over-arching department needs.
• Manages identified compliance issues related to areas of responsibility in accordance with Endpoint Clinical processes and procedures, as needed.
• Contributes to other tasks, as deemed necessary, to accommodate changes in the scope of the QMS or organization.

Education:

• 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:

• 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. 

Skills:

• Strong communication (written and verbal), organizational, and interpersonal skills.
• Strong decision-making skills.
• Project management skills and a high level of attention to detail.
• A demonstrated ability to work in a fast-paced, cross-functional team environment.
• The position requires a highly diplomatic and tactful individual with exceptional critical reasoning skills. 
• Experience in developing SOPs for quality assurance and compliance.
• Strong collaboration and development skills.
• Proactive team player enthusiastic with high work ethics. 
• Proficient in Microsoft Office applications (Outlook, Word, Excel, Visio, Microsoft Project, Power Point) and Adobe Acrobat Professional.

Endpoint Clinical does not accept unsolicited resumes from search firms or any other third parties. Any unsolicited resume sent to Endpoint Clinical will be considered Endpoint Clinical property, and Endpoint Clinical will not pay a fee should it hire the subject of any unsolicited resume.

Endpoint Clinical is an equal opportunities employer AA/M/F/Veteran/Disability.

Pursuant to the San Francisco Fair Chance Ordinance, we will consider for employment, qualified applicants with arrest and conviction records.

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