Exact Sciences

Principal Document Controller

Exact Sciences$136K — $232K *
Pharmaceuticals & Biotech
11 - 15 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's degree in a scientific major, Library Science, Communications, Business Administration, or related field.
  • 12 years of experience in document control within a large or multi-site regulated environment.
  • 5 years developing and training document control and Quality Management System (QMS) programs.
  • 5+ years in a clinical laboratory or other regulated setting.
  • 4 years leading audit/inspection readiness and document control evidence packages.
  • Exceptional written and verbal communication skills with attention to detail.
  • Advanced proficiency in Microsoft Office, especially Excel and Visio.

Responsibilities

  • Lead multiple complex document control initiatives with minimal oversight.
  • Govern enterprise document control governance and resolve complex issues.
  • Define the strategy and roadmap for the Document Control program.
  • Establish global best practices to optimize document control processes.
  • Ensure governance and strong controls of the Document Control System.
  • Advance enterprise-wide alignment through cross-functional leadership.
  • Guide audit readiness and support inspection activities.

Benefits

  • Paid time off for vacation, holidays, volunteering, and personal time.
  • Paid leave for parents and caregivers.
  • Retirement savings plan.
  • Wellness support and health benefits, including medical and dental coverage.
Full Job Description

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 communication skills with excellent attention to detail and organizational skills; ability to translate complex requirements into practical, scalable guidance.
  • Advanced computer skills with proficiency in Microsoft Office (including advanced Excel functionality/macros), Visio, and Word.
  • Applicants must be currently authorized to work in country where work will be performed on a full or part-time basis. We are unable to sponsor or take over sponsorship of employment visas at this time.

Preferred Qualifications

  • Strong knowledge of advanced continuous improvement methodologies such as Lean Six Sigma.
  • Technical Writer certification and/or 5+ years of technical writing experience (including leading or mentoring technical writing standards, templates, and governance for controlled documents).
  • Advanced training or certification in Microsoft Office/Microsoft 365 (e.g., advanced Excel/automation, SharePoint/Teams content governance), with demonstrated ability to design scalable document workflows and reporting.
  • 5+ years of experience as a MediaLab administrator, including role/permission management, workflow optimization, and end-user training across multiple teams/sites.
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Salary Range:

$136,000.00 - $232,000.00The annual base salary shown is for this position located in US - WI - Madison on a full-time basis. In addition, this position is bonus eligible.

Exact Sciences is proud to offer an employee experience that includes paid time off (including days for vacation, holidays, volunteering, and personal time), paid leave for parents and caregivers, a retirement savings plan, wellness support, and health benefits including medical, prescription drug, dental, and vision coverage. Learn more about our benefits.

About Exact Sciences

Exact Sciences is a biotechnology company that develops and commercializes diagnostic tests for the early detection and prevention of cancer. The company's flagship product is Cologuard, a non-invasive stool-based DNA test for colorectal cancer screening. Exact Sciences was founded in 1995 and is headquartered in Madison, Wisconsin.
Learn more about Exact Sciences
Size
6,420 employees
Market Cap
$9.2 billion
Industry
Net Income
-$848.5 million
Founded
1995
5 Year Trend
+77.8%
Revenue
$1.4 billion
NASDAQ

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