Exact Sciences logo
Exact Sciences

Exact Sciences is a publicly-traded molecular diagnostics firm focusing on early detection and prevention methods for some of the most life-threatening forms of

Principal Document Controller

Location

Wisconsin

Posted

4 days ago

Salary

$136K - $232K / year

Seniority

Senior

Bachelor Degree

Job Description

Principal Document Controller

Exact Sciences

Title: Principal Document Controller Location: Madison United States Job Description: 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 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. #LI-JS2 Salary Range: $136,000.00 - $232,000.00 The 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. Our success relies on the experiences and perspectives of a diverse team, and Exact Sciences fosters a culture where all employees can develop personally and professionally with a sense of respect and belonging. If you require an accommodation, please contact us here. Not ready to apply? Join our Talent Community to stay updated on the latest news and opportunities at Exact Sciences. We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to disability, protected veteran status, and any other status protected by applicable local, state, or federal law. To view the Right to Work, E-Verify Employer, and Pay Transparency notices and Federal, Federal Contractor, and State employment law posters, visit our compliance hub. The documents summarize important details of the law and provide key points that you have a right to know.

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