QA Manager, Commercial Production

Exact Sciences • Madison, WI

23d • $109,000 - $185,000

About The Position

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 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.

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 Haves

• 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.

Responsibilities

• 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.

Benefits

• paid time off (including days for vacation, holidays, volunteering, and personal time)
• paid leave for parents and caregivers
• a retirement savings plan
• wellness support
• health benefits including medical, prescription drug, dental, and vision coverage

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Number of Employees: 5,001-10,000 employees