Director, Quality Operations, Commercial Manufacturing – Cell & Gene Therapy

Role Summary

Director, GMP Operational Quality (Compliance) responsible for oversight of Commercial and/or Development Quality team activities, technical development of personnel, and ensuring the quality of deliverables and oversight of QMS system records (deviations, CAPA, and change controls) supporting cell and gene therapy programs. The Director is an advanced technical resource in the principles and application of quality assurance and compliance, has experience in participating in cross-functional teams working with deviations, root cause analysis, and CAPAs, as well as developing and communicating department QMS metrics and leading internal Tier meetings such as investigation and change control review boards. The incumbent is a key Quality and Compliance technical expert and assists with the strategic alignment of group and department goals, compliance and continuous improvement projects and activities, and refining and adapting processes and procedures as necessary through proactive monitoring/measurement.

Responsibilities

• Collaborate with internal and external business partners to resolve complex quality issues to ensure compliant solutions for development and commercial cell and gene products.
• Participates in and drives improvements for Quality Leadership Team (QLT) and Quality Management Review (QMR) as applicable, including providing metrics and KPIs and leading CAPA and/or mitigations when metrics do not meet targets.
• Acts as Quality Owner for major/critical deviations, including review and approval of associated CAPA, and coordinates with Manufacturing Technical Ops (MTO) to ensure assignment within QA team for minor quality events. Serves as Quality Lead for CAPA and Event Review (CERC) and Change Control (CC) committees.
• Participates in cross-functional teams as an experienced Quality technical resource.
• Assists Change Control owners with ensuring compliance to change procedure requirements, assesses and approves change controls as Quality.
• Be the Quality triage and impact assessor of investigations/deviations, reviews corrective action plans for adequacy and compliance. This includes root cause analysis and product impact assessments for investigations.
• Ensures appropriate CAPA actions are identified and addressed.
• Maintains Quality Metrics to support process improvement activities
• Proactively identify, assess and mitigate risks and gaps to cross-functional quality systems and technical quality processes.
• Responsible for coordinating, facilitating and follow up on any Quality leadership team (QLT) action items assigned.
• Supports audit programs and inspection readiness including assisting in preparation of audit responses for Cell & Gene Audits.
• Act as a trusted advisor by providing compliance guidance through collaborative review and partnering with business stakeholders and contract manufacturers.
• Execute improvements to QA operations processes.
• Participate/ lead Cell & Genetic Program and Quality projects, including key member of Process Owner Network (PON), and drive continuous improvement activities.

Qualifications

• 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
• Expertly lead cross-functional teams and represent the interests, strategies and objectives of Quality unit
• Substantial 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; negotiation skills may 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)

Education

• Bachelor's degree in a scientific or allied health field (or equivalent degree).
• Typically requires 10+ years of work experience and 3 years of management experience, or the equivalent combination of education and experience.
• Experience in Biologics and/or Cell and Gene commercial manufacturing quality.