The Vertex Quality Assurance Organization is looking for a Director, QA Compliance - Manufacturing Operations - Cell Therapy to ensure the operational compliance of CMC activities at their internal manufacturing site for Cell & Gene. This role will be responsible for overseeing site compliance, identifying and mitigating risks, and ensuring the site is ready for regulatory inspections.
Requirements
- In-depth GxP experience with current knowledge of industry trends, HA regulations & expectations, and best practices
- Extensive knowledge of commercial readiness, with CMC inspection operational readiness, leading regulatory authority inspections at a manufacturing site
- Broad knowledge of Cell & Gene therapy and/or Biologics, aseptic manufacturing processing.
- Ability to lead improvement projects - experience with Root Cause Analysis, data analytics, and other Operational Excellence experience, such as LEAN, DMAIC, Six Sigma
- Ability to apply risk management principles to decision making and operational priorities.
Responsibilities
- Serves as manufacturing site CMC Compliance Lead with responsibility for the overall strategic direction, oversight, performance and effectiveness of the site compliance as well as operational inspection readiness program. This includes site self assessments, gamba walks and overall continuous compliance improvements.
- Responsible for identification of compliance gaps/risks, drives alignment on mitigation and assures action execution to closure.
- Develops and implements strategies for operational readiness, including mock inspections, and site preparation.
- Partners with the QA Operations and cross-functional leadership in ensuring overall operational execution, readiness and site maturity program.
- Collaborating with cross-functional teams to develop and implement effective corrective and preventive actions (CAPAs) in response to audit and inspection findings.
- Collaborates with the Global Quality Audit and Inspection Management to enable execution and maturity of site for pre-approval inspection and other inspection readiness.
- Monitoring and analyzing key performance indicators (KPIs) related to internal audits, inspections and compliance, external intelligence for CGT regulatory inspections, and identifying areas for improvement.
Other
- Typically requires 12+ years of relevant industry experience in a commercial manufacturing site in biotechnology/regulated pharmaceutical environment.
- Strong leadership skills with the ability to organize and execute tasks effectively.
- Excellent communication skills and a proven track record Influencing/building/promoting a culture of Quality and Excellence.
- Ability to manage multiple projects, work in a dynamic environment and communicate effectively with senior leaders.
- 5% travel may be required.
