Associate Director, GMP Operational Quality - Cell & Genetic Therapies

Vertex Inc.•Boston, MA

50d•$156,600 - $234,800•Hybrid

About The Position

The Associate Director, GMP Operational Quality is responsible for oversight of team activities, development of personnel, and ensuring the quality of deliverables within the department's purview. The incumbent possesses comprehensive knowledge of the principles and application of quality assurance and compliance. This role is responsible for developing group goals and projects, ensuring alignment with corporate goals and compliance with all regulatory requirements, and refining goals and projects as necessary. The incumbent not only coordinates group responsibilities to ensure timely delivery to support business needs but also mentors team members to foster individual development and provide efficient and valuable service to project teams. At Vertex, we embrace continuous learning and encourage employees to stay informed on advances in AI, technology, automation, and industry trends. We seek talent who bring an external perspective, demonstrate curiosity and sound judgment, and thoughtfully adopt new capabilities that improve decision-making, drive innovation, increase efficiency, and help deliver better outcomes for patients.

Requirements

In-depth and specialized knowledge of both the conceptual and practical application of cGMPs in a pharmaceutical setting; in-depth 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.
Strong 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 independently lead cross-functional teams and represent the interests, strategies and objectives of Quality unit.
Strong skills in mentoring staff and transferring technical knowledge to enable their capabilities and development.
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.
Demonstrated ability to evaluate complex quality matters and make decisions utilizing risk-based approach; identifies and leverages the appropriate expertise to implement solutions.
Substantial 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., QDocs, Trackwise, Veeva).
Bachelor's degree in a scientific or allied health field (or equivalent degree).
Typically requires 8+ years of work experience and 2 years of management experience, or the equivalent combination of education and experience.

Nice To Haves

External perspective
Curiosity
Sound judgment
Thoughtfully adopt new capabilities that improve decision-making, drive innovation, increase efficiency, and help deliver better outcomes for patients.

Responsibilities

Lead a Quality team: primarily responsible for providing quality oversight and support to business activities within purview at Vertex.
Collaborate with internal and external business partners to resolve complex quality issues to ensure compliant solutions.
Oversee CMO/Vendor performance, establishment of Quality Agreements and adherence of Quality Agreement terms.
Enable team to achieve team goals/objectives and enable their individual career development.
Develop and maintain compliant quality processes to support GMP activities.
Oversee the QA support of Change Controls, GMP investigations and associated CAPAs.
Track performance metrics and report to Sr Management; develops tactics to improve performance outcomes.
Participate in inspection readiness activities and lead Quality development discussions as necessary during regulatory site inspections.
Support review of regulatory submissions, as applicable.
Lead continuous improvements of department processes, realizing efficiency gains, and ensuring team continues to meet expanding business needs with lean resources.
Lead and follow up on any QLT action items assigned.
Identify and communicate risks and assist with risk mitigation plans as necessary.
Supports internal audit or external audit programs; assists in preparation of audit responses.
Provide comprehensive knowledge support for partner and regulatory agency audits.
Assist management team in budgeting and scheduling.
Responsible for talent acquisition/recruiting/interviewing/selection/onboarding.
Responsible for performance management (goals, monitoring, reviews).
Responsible for monitoring/supporting employee engagement and retention.
Responsible for succession planning.
Accomplish staff results by communicating job expectations, planning, coaching, training and developing personal growth opportunities through IDPs.
Provide oversight of day-to-day team operations.
Assist with workforce planning/resource modeling and to update through forecasting activities.