Manager, Validation - Manufacturing Sciences

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Position Overview

The Manager, Validation will provide strategic direction and oversight of the validation program across multiple Exact Sciences' locations. This position will work cross-functionally to oversee the development, planning, execution, and maintenance of validation activities. The validation program includes commissioning, qualification, validation and revalidation projects for facility, equipment, test methods, computer systems, cleaning, sterilization, and medical device/drug product manufacturing processes according to Exact Sciences' Quality Management system, current Good Manufacturing Practices (cGMP), and ISO requirements.

Essential Duties

Include, but are not limited to, the following:

• Oversee the validation program and ensure compliance with the company's Quality Management System policies and procedures, current Good Manufacturing Practices (cGMP), ISO requirements, and ICH guidelines.
• Maintain the qualified state of validated systems (e.g. Equipment, Facility, Computerized Systems, Processes, Cleaning, Test Methods, etc.) through validation impact assessments using the change control process.
• Coordinate cross-functional teams to identify validation requirements and ensure timely completion of validation activities
• Lead validation design strategy and investigations for validation deviations / non-conformances.
• Review quality documentation including but not limited to Validation Plans, Validation Protocols, Validation Summary Reports, manufacturing Work Instructions, Failure Modes and Effects Analysis (FMEA) risk assessments, and method development reports.
• Serve as a project team member to provide validation guidance to streamline commissioning and/or development activities.
• Lead and facilitate continuous improvement or efficiency initiatives within cross functional teams to improve cost of goods sold, drive reliability in process, and deliver quality.
• Drive clear communication and expectations regarding project and Validation deliverables to all levels of the organization.
• Lead and support scale-up and capacity expansions efforts to drive productivity and meet company initiatives.
• Collaborate with senior leadership in Operations on new product introduction projects and transfers partnering with Research and Development or external vendors in developing, transferring, scaling, and validating manufacturing processes.
• Effectively manage, support, and guide your team, including, but not limited to, delegating tasks and responsibilities, assessing employee performance and providing helpful feedback and training opportunities.
• Consistent demonstration of exceptional leadership qualities, including, but not limited to the ability to attract and retain the best team, foster a culture of high performance, lead with integrity, humility, accountability, and courage, and set a clear vision to energize teams towards the future.
• Ability to effectively work on many complex and varied projects at one time, with frequent changing priorities.
• 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.
• Maintain regular and reliable attendance.
• Ability to act with an inclusion mindset and model these behaviors for the organization.

Minimum Qualifications

• Bachelor's Degree in Life Sciences, Engineering, or a related field.
• 10+ years of experience working in a manufacturing environment.
• 5+ years of experience in biotech of pharmaceutical manufacturing, within FDA regulated and ISO13485 environments.
• 3+ years of experience leading a diverse team in a manufacturing environment.
• Strong documentation, attention-to-detail and procedure writing skills suitable for a cGMP environment.
• Strong analytical, problem-solving skills and negotiating skills. Ability to make decisions with limited information and operate with autonomy.
• Proficient in Microsoft Office programs, such as: Word, Excel, PowerPoint, Outlook, OneNote)
• Demonstrated ability to perform the essential duties of the position with or without accommodation.
• Authorization to work in the United States without sponsorship.

Preferred Qualifications

• Basic knowledge of molecular biology and PCR.
• Proficient with SAP.

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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