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Exact Sciences Logo Exact Sciences · Quality Control

QA Manager, Commercial Production

United States, Madison 109000.00 - 185000.00 USD / Year · Job Posted February 18, 2026
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Job Description

The Manager, Quality will lead the Quality team in providing guidance and direct leadership to Exact Sciences for a variety of functions, including manufacturing, validation activities to support production, supplier programs, internal and external audit programs, establishment and maintenance of technical processes, procedures and work instruction, and administration in the implementation and maintenance of documentation processes and risk management. The position will also provide direct support to Operations support for day-to-day activities such as investigation support and material release.

Job Responsibility

  • Collaborate directly with operations and validation management in project management and status updates for ongoing activities
  • Provide support to Operations personnel in the completion of validation efforts for process, test method, and facility qualification/validation
  • Lead processes relating to supplier activities and audit programs
  • Provide Operations support for investigations and material release
  • Participate in FMEA process risk assessments
  • Key contributor for developing consistent strategies for Quality System requirements and improvements, and quality record workflow optimization
  • Implement, conduct and report on process quality programs using statistical data analysis
  • Participate as a Quality representative on design transfer and process improvement projects
  • Provide timely and transparent communication to project teams and upper management, including establishment of effective metrics for Management Review
  • Generate, prepare, and issue data for assigned quality reports
  • Perform other related duties as assigned by management

Requirements

  • Bachelor’s degree in an engineering or science field with focus on Biology and/or Chemistry, or related field with the equivalent combination of education and experience
  • 5+ years’ experience in a biotech manufacturing environment, preferably in a GMP and/or ISO13485 environment
  • 2+ years’ experience in a supervisory position in an Operations and/or Quality role
  • 3+ years’ experience in Process Validation principles and practice
  • Proven ability to lead and work effectively with and through multi-functional teams to achieve results
  • Knowledge and experience working within a CFR 820, ISO 13485, ISO 9001 and/or cGMP structured environment
  • Authorization to work in the United States without sponsorship
  • Demonstrated ability to perform the Essential Duties of the position with or without accommodation

Nice to have

  • Experience with Project Management principles and practice
  • Demonstrated experience in Validation Projects in a GMP environment
  • Demonstrated experience in support of Facility expansion and qualification

What we offer

  • Paid time off (including days for vacation, holidays, volunteering, and personal time)
  • Paid leave for parents and caregivers
  • Retirement savings plan
  • Wellness support
  • Health benefits including medical, prescription drug, dental, and vision coverage
  • Bonus eligibility
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