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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