Senior Specialist, Quality Document Management & Training

Join Foresight Diagnostics as a Senior Specialist, Quality Document Management & Training

Are you passionate about ensuring quality and regulatory compliance in a fast-growing molecular diagnostics company? Foresight Diagnostics, a venture-backed leader in non-invasive cancer detection technologies, is seeking a highly motivated and detail-oriented Senior Specialist, Quality Document Management & Training to join our team. This pivotal role offers the flexibility of a remote, hybrid, or onsite work arrangement at our headquarters in Boulder, CO.

About Foresight Diagnostics

At Foresight Diagnostics, we are committed to improving patient lives through earlier and more accurate cancer detection. Our innovative cell-free DNA based liquid biopsy tests, developed from groundbreaking research at Stanford University, are revolutionizing personalized cancer treatment. We offer a dynamic and collaborative work environment where you can make a significant impact and accelerate your professional growth. We’re seeking a talented and passionate individual to help us scale our Quality Management System.

The Opportunity: Become Our Document Control Expert

As the Senior Specialist, Quality Document Management & Training, you will be responsible for supporting and managing all aspects of document control and the quality training program. Reporting to the Senior Director, Clinical Quality, you will serve as the subject matter expert for document management and quality training. You will play a vital role in ensuring our compliance with regulatory requirements (FDA, ISO, CAP/CLIA) and driving continuous improvement across our Quality Assurance department.

What You’ll Do

• Document Management: Oversee the entire document lifecycle, from creation and review to approval, distribution, and archival, ensuring compliance with GxP regulations and internal policies.
• eQMS Administration: Serve as the administrator for our Electronic Quality Management System (eQMS), managing user access, privileges, and system workflows, and contribute to system optimization.
• Training Coordination: Manage training assignments, develop training plans in collaboration with department leaders, design and maintain training requirements and curriculums, and generate compliance reports.
• Continuous Improvement: Identify and implement improvements to document management processes and training programs to enhance efficiency and scalability.
• Change Management: Support change management activities as needed, ensuring documentation accurately reflects changes and is properly communicated.

What You’ll Bring

• Bachelor’s degree in a Life Sciences discipline or equivalent experience.
• 3+ years of experience in document control or quality systems, preferably in a regulated industry (medical device, IVD, Pharma, or CAP/CLIA clinical diagnostic lab).
• Experience with MasterControl eQMS platform is highly preferred.
• Strong understanding of GxP regulations, including FDA, ISO, CAP/CLIA.
• Excellent organizational skills, attention to detail, and ability to manage multiple priorities in a fast-paced environment.
• Proficiency with Microsoft Office Suite and similar tools.
• Excellent communication and collaboration skills, with the ability to work independently and as part of a team.

Physical and Mental Requirements

This position requires the ability to learn new tasks, maintain focus, and complete tasks independently within a fast-paced workflow. Occasional travel to Boulder, CO, or other sites may be required. The role primarily involves sedentary work in an office environment.

Compensation & Benefits

The salary range for this role is $105,000 – $120,000 annually, plus bonus and equity opportunities. Foresight Diagnostics offers a comprehensive benefits package including paid time off, parental leave, medical, dental, vision, life, disability coverage, flexible spending accounts, and a 401k with company match. We are committed to fostering the professional development of our employees and offer opportunities for upward mobility.

Join Our Mission!

If you are a highly motivated and experienced quality professional seeking a challenging and rewarding opportunity, we encourage you to apply! Foresight Diagnostics is an equal opportunity employer.