Director of Quality Operations

4 weeks ago


Étreux, Hauts-de-France, United States Vertex Pharmaceuticals Full time
Job Summary

The Director of Quality Operations will serve as a key leader in the areas of process validation, equipment validation, and quality initiatives in support of Vertex Manufacturing Center (VMC) Facility operations.

Key Responsibilities
  • Lead the Quality Operations group in providing quality oversight and support to manufacturing operations, analytical laboratory operations, and material management.
  • Develop and grow the group to support Vertex, Quality, and VMC's vision.
  • Provide strategic leadership to achieve corporate and strategic goals, including inspection readiness and compliance with regulatory requirements.
  • Direct teams responsible for internal quality commercial and development operations, including disposition responsibilities of material produced internally at Vertex.
  • Ensure the development and implementation of quality initiatives, including process validation, equipment validation, and Quality by Design concept.
  • Participate in cross-functional projects and provide operational strategies to address compliance gaps.
  • Review batch data, including batch records, deviations, QC release testing, and other quality systems to determine the acceptability of product disposition.
  • Provide QA support for development and commercial change controls, GMP investigations, associated CAPAs, and Effectiveness Checks.
  • Monitor and track key metrics and trends, and propose solutions as needed.
Requirements
  • Master's degree in a relevant field and 8 years of relevant work experience, or Bachelor's degree in a scientific or allied health field (or equivalent degree) and 10+ years of experience.
  • Experience with drug product development and manufacturing, including CGMP's and associated CMC regulatory considerations.
  • Experience with continuous manufacturing, equipment, facilities, and utility system qualifications activities in a CGMP setting.
  • Strong leadership skills, project management, and continuous improvement experience.
  • Ability to lead and manage projects/teams within corporate objectives and project timelines.
  • Collaboration, teamwork, conflict management, and communication skills.
  • Flexibility, adaptability, attention to detail, and ability to work independently.
Flex Designation

This role is Hybrid-Eligible, allowing you to choose to work remotely up to two days per week or select On-Site, working five days per week on-site with ad hoc flexibility.

Vertex is an E-Verify Employer in the United States and is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law.



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