Operational Quality Director for Gene Cell Management
hace 3 semanas
The Associate Director, GMP Operational Quality Cell and Gene is responsible for the oversight of team activities, development of personnel, and ensuring quality of deliverables within the department's purview.
Key Responsibilities
• Collaborate with internal and external business partners to resolve complex quality issues and ensure compliant solutions.
• Enable team to achieve team goals and 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, and develop 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 the 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.
• Support internal audit or external audit programs, and assist in preparation of audit responses.
• Provide comprehensive knowledge support for partner and regulatory agency audits.
• Assist management team in budgeting and scheduling.
• Responsible for people management responsibilities, including talent acquisition, recruiting, interviewing, selection, onboarding, performance management, monitoring, supporting employee engagement and retention, succession planning, and accomplishing staff results.
Requirements
• In-depth and specialized knowledge of both the conceptual and practical application of cGMPs in a biotech setting.
• In-depth knowledge of global GMP requirements and managing quality in support of GMP manufacturing.
• Demonstrated success in building high-performing teams and skilled at managing team and individual development.
• Experience in Quality Control and Microbiology.
• 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 the 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, and exchange complex concepts with the ability to influence leaders, customers, or vendors to adopt a new point of view and/or to take action.
• Demonstrated ability to evaluate complex quality matters and make decisions utilizing a risk-based approach, and identify and leverage 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.
About Vertex
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 without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law.
Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
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