Exact Sciences Corporation

Senior Manager, Process Validation

Job Locations US-AZ-Phoenix
Req No.
2022-12152
Category
Clinical Operations
Type
Regular Full-Time

Summary of Major Responsibilities

The Senior Manager, Process Validation, will provide leadership and expertise in validation, configuration management, and partner with various groups for process improvement and system development for the Next Generation Sequencing clinical laboratories in Phoenix.

 

In this leadership role, you will foster close relationships with our engineering team, service team, clinical operations, and quality assurance to identify and validate new and innovative solutions to allow a more end to end solution for our NGS services. The ideal candidate will bring a core knowledge of NGS validation and the clinical laboratory testing environments.  This self-motivated, well organized, Senior Manager will apply best practices in validation and configuration management, train appropriate team members, and identify opportunities for continuous improvement.

Essential Duties and Responsibilities

  • Lead diverse technical teams for equipment and process validations in NGS clinical laboratories at Phoenix.
  • Collaborate cross-functionally to facilitate the effective transfer of methods and processes to the CLIA laboratories.
  • Partner with leadership, functional and program managers to identify appropriate scope of testing, verification and validation required for a project, and managing the overall testing activities.
  • Prepare, maintain, and review documentation on validation and compliance; including validation plans, risk assessments, specifications, protocols, reports, trace matrices, and change controls to ensure compliance with applicable business and regulatory requirements.
  • Work with other departments on deviations; including out of tolerance conditions and equipment issues observed during validation through failure analysis, determining the root cause, and taking corrective action.
  • Ensure team is on track and that project meets requirements, monitor progress and results, make recommendations for changes or improvements.
  • Promote agile development best practices and test-driven development culture.
  • Maintain effective communication with the engineering, quality, operations, and leadership on product risks, quality status, and progress.
  • Develop and maintain validation program with a risk-based testing approach.
  • Participate as the validation subject matter expert (SME) during internal and external audits/inspections.
  • Enforce Good Documentation Practices (GDP) and Data Integrity.
  • Contribute to cross-functional efforts that ensure compliance with the International Organization for Standardization (ISO); including ISO 13485, ISO 15189, ISO 62304, and other domestic and international regulations and standards.
  • Excellent interpersonal, written, and verbal 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.
  • Maintain regular and reliable attendance.
  • Ability to act with an inclusion mindset and model these behaviors for the organization.
  • Ability to work on a mobile device, tablet, or in front of a computer screen and/or perform typing for approximately 50% of a typical working day.
  • Ability to work seated for approximately 50% of a typical working day. Ability to work standing for approximately 50% of a typical working day.
  • Ability to lift up to 25 pounds for approximately 5% of a typical working day.
  • Ability to comply with any applicable personal protective equipment requirements.
  • May be exposed to hazardous materials, tissue specimens, and instruments with moving parts, lasers, heating and freezing elements, and high-speed centrifugation.
  • Ability to travel 15% of working time away from work location, may include overnight/weekend travel.

Qualifications

Minimum Qualifications

  • Bachelor’s Degree in Engineering, Science, or related field.
  • 10+ years of experience in equipment and process validation in the IVD regulated or clinical laboratory environment.
  • 2+ years of experience with validation project management and leading validation program.
  • 2+ years direct laboratory experience with NGS instrumentation and validation.
  • 2+ years in supervisory role.
  • Working knowledge of automated instruments integrated with Information Management Systems (IMS).
  • Demonstrated ability to enforce GDP and Data Integrity.
  • Demonstrated ability to work with cross-functional teams through the design, testing, and implementation of automation workflows.
  • Demonstrated ability to partner with multiple teams to build compliant workflows, processes, and procedures.
  • 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

  • Bioinformatics background a plus.
  • Experience with a variety of different NGS methods and different analytes.
  • Experience in programming automated laboratory instruments and/or systems; including liquid handling robotics.
  • Knowledge of The College of American Pathologists (CAP) and/or Clinical Laboratory Improvement Amendments (CLIA) law and regulations.

We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state, or federal law. Applicable portions of the Company’s affirmative action program are available to any applicant or employee for inspection upon request.

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