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 also 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 also oversee QC data review and product disposition. This is a full-time on-site role.

Key Duties and Responsibilities:

The responsibilities of this position may include, but are not limited to, the following:

• Led the Quality Operations group primarily responsible for providing quality oversight and support to the Vertex Manufacturing Center (VMC) Facility operation in the following key areas/activities; support of manufacturing operations across all phases of development and commercial, support of analytical laboratory operations, and material management including engineering, validation/qualification, and facilities/utilities. Ensure the development and growth of the group to support Vertex, Quality, and VMC's vision.
• Provides strategic leadership, to achieve the corporate and strategic goals to support clinical and commercial manufacturing, continuous improvements, and maintain the inspection readiness state of the facility.
• Enables strategic enhancements in alignment with the Senior Quality Leadership Team.
• Provide 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, including disposition responsibilities of material produced internally at Vertex.
• 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.
• Provides operational strategies to address compliance gaps.
• May be required to assist with commercial and clinical batch disposition activities. Review batch data, including batch records, deviations, QC release testing, and other quality systems as applicable to determine the acceptability of product disposition.
• 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; and 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 through collaborative review and working with the business owners to gain a better understanding of their needs and facilitate resolution of quality issues on time.
• Review and approval of new product risk assessment, equipment cleaning verification/method qualification documents, and related supporting documents.
• Responsible for providing QA oversight of internal process and cleaning validation activities and evaluation of process being in a state of control.
• Responsible for review/approval of validation protocols and reports.
• Participate in inspection readiness activities and provide support during regulatory site inspections. Provide post-inspection support to address any regulatory observations.
• Responsible for workforce planning/resource modeling and updating through forecasting activities.

Knowledge and Skills:

• Strong leadership skills with the ability to thrive in a high throughput environment.
• Project Management / Continuous Improvement.
• Ability to lead and manage projects/teams within corporate objectives and project timelines.
• Proficient in utilizing project management processes/tools to lead meetings, assist with project planning, and facilitate completion of tasks.
• Demonstrated ability to work independently to provide QA support for large, multifaceted projects.
• Collaboration / Teamwork / Conflict Management.
• Ability to independently lead cross-functional teams and represent the Quality unit.
• Ability to understand and translate business needs.
• Recognized as a mentor with a strong ability to transfer technical knowledge and teach skills to junior staff.
• Represents Vertex Commercial Quality Assurance on cross-functional working teams and is recognized for strong communication and influencing skills.
• Critical Thinking / Problem Solving.
• Ability to evaluate quality matters and make decisions utilizing a risk-based approach.
• Flexibility/Adaptability.
• Attention to detail.
• Knowledge in the following areas:
  • Expert knowledge of global GMP requirements governing oral drug products and knowledge of oral drug product manufacturing practices.
  • GMP/GDP regulations and application to Manufacturing and Testing risk management principles.
  • Root Cause Analysis tools/methodology.
  • Audit process.
• Broad GxP Knowledge and understanding across the lifecycle of the product.
• Sense of urgency and priority- the ability to act quickly/escalation process/transparency.

Education and Experience:

• 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).
• 10+ years of experience, or the equivalent combination of education and experience.
• Experience with drug product (oral solid dosage forms preferred) development and manufacturing with proficient knowledge of the following in a pharmaceutical setting:
  • CGMP's and associated CMC regulatory considerations.
  • Experience with continuous manufacturing a plus.
• Experience with equipment, facilities, and utility system qualifications activities in a CGMP setting.
• Experience successfully leading event investigations, Root Cause Analysis (RCA), CAPA, QbD, QRM.
• Strong communication skills, tact, and diplomacy.