Director, GMP Operational Quality (On-site)

Director, GMP Operational Quality (On-site)

Job Description

General Position Summary: The GMP Quality Operations Director serves as a Quality leader in the areas of process validation and equipment validation in oral solid dosage form. The Director is responsible for managing multiple department activities with a high degree of independence while providing oversight of the development, implementation, and maintenance of relevant quality initiatives in support of their function. The leader is adept at troubleshooting problems and shall develop strategies for coordinating and executing activities on multiple complex projects and ensuring alignment with corporate goals and compliance with all regulatory requirements. In addition, the leader will oversee QC data review and product disposition. This is a full-time on-site role.

Key Responsibilities:

• Led the Quality Operations group primarily responsible for providing quality oversight and support to the Vertex Manufacturing Center (VMC) Facility operation.
• Provides strategic leadership to achieve corporate and strategic goals to support clinical and commercial manufacturing.
• Enables strategic enhancements in alignment with the Senior Quality Leadership Team.
• Provides operational strategies to address compliance gaps or determine enhancements to cross-functional quality systems.
• Directs teams responsible for internal quality commercial and development operations in support of GMP manufacturing and testing activities.
• Requires in-depth knowledge of Phase-appropriate GMPs.
• Expert in process validation, equipment validation, Quality by Design concept, and implementation.
• Participates in cross-functional projects in a Quality expert role.
• May assist with commercial and clinical batch disposition activities.
• Provide QA support for development and commercial change controls, GMP investigations, associated CAPAs, and Effectiveness Checks.
• Responsible for monitoring and tracking key metrics and trends; proposing solutions as needed.
• Lead/assist compliance walkthroughs of the site and help drive the closure of any observations.
• In-depth knowledge of Quality Risk Management (QRM) principles and applications.
• Act as a trusted advisor to the site by providing compliance guidance.
• Review and approval of new product risk assessment and related supporting documents.
• Responsible for providing QA oversight of internal process and cleaning validation activities.
• Participate in inspection readiness activities and provide support during regulatory site inspections.
• Responsible for workforce planning/resource modeling and updating through forecasting activities.
• Strong leadership skills with the ability to thrive in a high throughput environment.

Minimum Qualifications:

• Master’s degree in a relevant field and 5 – 8 years of relevant work experience, or Bachelor's degree in a scientific or allied health field (or equivalent degree) with 10+ years of experience.
• Experience with drug product (oral solid dosage forms preferred) development and manufacturing.
• Experience with equipment, facilities, and utility system qualifications activities in a CGMP setting.
• Experience leading event investigations, Root Cause Analysis (RCA), CAPA, QbD, QRM.
• Strong communication skills, tact, and diplomacy.

On-Site Roles

In this On-Site designated role, you will work five days per week on-site with ad hoc flexibility.

Company Information

Vertex is a global biotechnology company that invests in scientific innovation. Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants.