About us:

endpoint is at the forefront of the evolving e-clinical technology industry with more than 20 years of experience designing, enhancing and deploying robust, configurable IRT solutions.

At our core is a commitment to the continuous evolution and enhancement of IRT to improve your trial management. Our unique, single-focus approach makes endpoint the only company with the knowledge and experience needed to drive IRT and e-clinical integration paradigm shifts in the industry.

Position Overview:

The Systems Engineer - QTC is primarily responsible for managing and supporting assigned QTC activities, including coordinating client and regulatory inspection preparation and support activities, preparing training materials for internal personnel, and performing regulatory intelligence activities. They will also be responsible for designing, evaluating and implementing updates to the endpoint Quality Management System (QMS) to ensure compliance as set forth by regulatory agencies.

*This position must be based in Wakefield, MA or San Francisco, CA.

Responsibilities:

• Perform development and revision of Controlled documents such as Standard Operating Procedures, Policies, Templates and Work Instructions, including ensuring that procedures meet minimum regulatory, privacy and security requirements.
• Perform Quality Management System documentation, Quality Control reviews, and provides feedback to key stakeholders as needed.
• Administer all aspects of Internal Audits including preparation, execution of the audit plan and create Internal Audit reports upon assignment
• Lead and host client external audits, report observations and other potential concerns to the auditees/process owners/subject matter experts and
• Manage projects, as identified, in client requests for information and questionnaire activities.
• Plan and conduct audits of critical service providers and vendors by verifying that the vendor meets minimum regulatory, privacy and security requirements.
• Participate in and/or Lead the Governance and Audit Team’s review of new or updated regulatory, privacy and/or security requirements to identify gaps in endpoint procedures
• Work closely with internal departments, including Operations, R&D, and Information Technology to assure compliance with internal quality systems and regulations issued by the Food and Drug Administration (FDA) and other applicable regulatory bodies and with applicable privacy and security requirements.
  • Work closely with internal departments to evaluate and identify significant organizational risks, evaluate internal controls to determine effectiveness and efficiency and verify that procedures are implemented according to approved processes
• Participate in internal investigations by working closely with internal departments and providing feedback from a regulatory perspective
• Lead the design and evaluation of training materials for different regulations and quality systems and deliver training to endpoint personnel, including the training and qualification of internal auditors
• Participate in conducting periodic Product Quality and Management Review, including tracking, trending all KPIs (QTC metrics) and design action plans to address trends, including assessing compliance risk, data governance issues, process efficiency, and adherence to policies and procedures.
• Identify, analyze and communicate QTC strategies, KPI metrics, gaps and compliance risks to senior management on a periodic basis.
• Design and implement Process Improvement projects.
• Represent QTC on multi-disciplinary project teams as required

Qualifications:

Education:

• M.S. degree and minimum 2 years of related experience OR BS/BA degree and minimum 7 years of related experience
• Certification in Quality Assurance or Regulatory Affairs preferred (ISO 13485, ISO 127001, ASQ-CBA or ASQ-CQA)
• Relevant experience preferably in the clinical trial industry, IRT experience is highly desired.
• Familiarity with the appropriate regulations, including 21 CFR Part 11, Good Clinical Practices (GCPs), Annex 11, applicable ICH guidelines (ICH E6 R2)
• Experience in developing SOPs for quality assurance and compliance.

Experience:

• Strong communication (written and verbal), organizational, and interpersonal skills.
• Demonstrated ability to work in a fast-paced, cross-functional team environment.
• Highly diplomatic and tactful individual with exceptional critical reasoning skills who is detail oriented.
• Strong collaboration and development skills.
• Proactive team player enthusiastic with high work ethics.
• Experience with Microsoft Office applications (Outlook, Word, Excel, Visio, Microsoft Project, Power Point).

Project management skills and high level of attention to detail.

endpoint 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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