Director – GMP Operational Quality

Director – GMP Operational Quality

Requirements

• Bachelor’s degree in a scientific or allied health field
• Master’s degree is preferred
• Typically requires 10 years plus of work experience and 3 years of management experience, or the equivalent combination of education and experience
• Expert knowledge of both the conceptual and practical application of cGMPs in a pharmaceutical setting
• Expert knowledge of global GMP requirements and managing quality in support GMP manufacturing
• Demonstrated success in building high-performing teams and skilled at managing team and individual development
• Highly effective management skills with the ability to lead and motivate a team in a fast-paced environment while maintaining a high degree of quality, accuracy and timeliness
• Substantial background in managing complex projects/teams within stated objectives and timelines and with a strong understanding of the underlying business drivers
• Skilled at applying project management processes / tools to lead meetings, assist with project planning, and facilitate attainment of project objectives
• Ability to communicate cross-functionally to a wide variety of audiences; exchanges complex concepts with the ability to influence leaders, customers, or vendors to adopt of a new point of view and/or to take action; negotiation skills may be required
• Demonstrated ability to evaluate unusually complex quality or multi-disciplinary matters and make decisions utilizing risk-based approach; identifies and leverages the appropriate expertise to implement solutions
• Extensive experience successfully leading event investigations, Root Cause Analysis (RCA), and CAPA
• Extensive exposure with multiple regulatory agencies across applicable GxPs during inspections
• Substantial experience with electronic document management systems (e.g., QDoccs, Trackwise, Veeva)

Responsibilities

• Directs multiple teams responsible for internal commercial operations in support of GMP manufacturing and testing activities, including disposition of intermediates, working cell banks and clinical and commercial drug product internally at Vertex manufacturing facilities
• Responsible for clinical and commercial batch release, for Us and ex US markets including liaising with QP certification and importation requirements where applicable
• Monitors operational activities and assesses for continuous improvement within the QA operations
• Proactively identify trends/gaps/risks and implement plan to mitigate such trends/gaps and risks
• Prepare metrics and participate in Business /Functional Review Meetings to ensure Quality issues are raised and addressed, as necessary
• Provide guidance and support to in-country Quality responsible person requests in relevant geographies
• Leads Material Review Board (MRB) discussions, as necessary
• Ensures quality staff assesses and approves change controls for commercial processes for assessment of lot disposition process
• Leads and manages highly complex projects/teams within corporate objectives and project timelines
• Participates in cross-functional projects in Quality Assurance operations role
• Provide support/lead or assist with preparing for and hosting partner audits and regulatory agency inspections
• Collaborates with in house Quality counterparts
• Responsible for team goal setting in best pursuit of corporate and department goals
• Mentors to staff on quality and technical related areas
• Responsible for team development

Preferred Qualifications

• Master’s degree is preferred