QA Manager, Commercial Production

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Position Overview

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.

Essential Duties

include but are not limited to the following:

• 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.

• Excellent interpersonal skills with the ability to collaborate closely with Operations staff at varying levels to drive compliance and operational excellence.

• Excellent oral and written communication skills.

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

• Support and comply with the company's Quality Management System policies and procedures.

• Regular and reliable attendance.

• Ability to use computers daily in an interactive manner for extended periods of time.

• Ability to sit for an extended period of time.

• Ability to frequently and accurately communicate with employees in person, via the telephone or by email.

• Ability to travel (by land and air), both domestically and internationally.

Minimum Qualifications

• 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.

Preferred Qualifications

• 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.

Salary Range:

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.

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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.

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