Principal Document Controller

Help us change lives

At Exact Sciences, we're helping change how the world prevents, detects and guides treatment for cancer. We give patients and clinicians the clarity needed to make confident decisions when they matter most. Join our team to find a purpose-driven career, an inclusive culture, and robust benefits to support your life while you're working to help others.

Position Overview

The Principal Document Controller provides enterprise leadership for the Document Control program, driving complex, high-impact initiatives that support organizational objectives and regulatory compliance. This role serves as the strategic and technical subject matter expert for document control governance, systems, and processes, defining the long-term program vision and delivering scalable, integrated solutions. Through cross-functional alignment, the role establishes global best practices that optimize the document lifecycle, improve user experience, reduce risk, and ensure audit readiness.

Location:

1 Exact Lane, Madison, WI

Work Arrangement:
This is a hybrid role, working on-site 4 days/week and ability to be remote 1 day/week.

Relocation:
Relocation benefits are available and will be discussed in an interview.

Essential Duties

Include, but are not limited to, the following:

* Independently lead multiple complex, enterprise-impacting initiatives, setting priorities, managing tradeoffs and adjusting scope to deliver outcomes aligned with organizational goals and regulatory requirements, with minimal oversight.

* Own enterprise governance of the Document Control program and system ecosystem, serving as a technical SME to resolve complex issues and drive cross-functional execution through influence and aligned accountability.

* Define and evolve Document Control program strategy and vendor roadmap, translating long-term vision into scalable system capabilities, integrations, and solutions that support business growth and evolving compliance needs.

* Establish enterprise standards and drive global optimization of document control processes and systems, establishing global best practices that enable document sharing, reuse, and standardization while improving user experience, reducing rework, and strengthening compliance and reducing risk.

* Own governance and performance of the Document Control System, ensuring disciplined lifecycle execution, strong controls, and consistent enterprise adoption of current procedures.

* Influence enterprise-wide alignment across functions, advancing integrated solutions and harmonized governance models through cross-functional leadership and stakeholder engagement.

* Serve as an enterprise subject matter expert, guiding audit readiness and supporting program related inspection activities, and driving effective remediation through influence across teams.

* Demonstrate excellent attention to detail and strong verbal, written, and organizational skills; produce clear, accurate, and audit-ready documentation.

* Interface and work effectively in a highly professional manner with all levels of the organization, including laboratory leadership, vendors, auditors/regulators, and customers as applicable.

* Work effectively in a team environment and adapt to changing workload and circumstances; respond quickly to new information and shifting priorities.

* Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork.

* Support and comply with the company's QMS policies and procedures.

* Maintain regular and reliable attendance.

* Ability to lift up to 40 pounds for approximately 25% of a typical working day.

* Ability to work on a mobile device, tablet, or in front of a computer screen and/or perform typing for approximately 90% of a typical working day.

* Travel between Exact Sciences locations as needed.

* Travel up to 5% of working time, which may include overnight or weekend travel.

Minimum Qualifications

* Bachelor's degree in a scientific major, Library Science, Communications, Business Administration, or related field.

* 12 years of experience working with document control in a large and/or multi-site, regulated environment, including direct experience administering electronic document management systems.

* 5 years of experience developing, governing, administering, and training document control and Quality Management System (QMS) programs, including driving enterprise standardization and best practices.

* 5+ years of experience in a clinical laboratory setting or other highly regulated environment.

* 4 years of experience supporting and leading audit/inspection readiness and responses (internal and external), including direct interaction with regulatory or accreditation bodies (e.g., CAP, NYSDOH, FDA) and ownership of document control evidence packages.

* Demonstrated ability to collaborate across functions and influence senior stakeholders, communicating recommendations proactively and professionally to drive alignment and decision-making.

* Exceptional written and verbal…