Director of Quality Operations
4 weeks ago
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.
- 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.
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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