The Director, Product Quality for the Biologics and Device Quality organization is accountable for end-to-end quality oversight of Biologics and Combination Device program(s) throughout clinical development, commercialization, filing, approval, launch, and post approval lifecycle management activities for Vertex
Requirements
- Expertise in Biologics and Combination Device global cGMP compliance, FDA guidelines, and international guidelines dealing with pharmaceutical manufacturing and Quality Assurance
- Demonstrated application of the principles of cGMP and Quality Assurance
- Experience in the practicalities of implementing 21st century cGMP guidelines, ICH Q8/9/10/11, PAT/ASTM guidance, etc
- In-depth understanding of quality processes/systems (e.g., change control, event handling, CAPA), risk management and manufacturing control strategies
- Direct experience with regulators (e.g., NDA, BLA, MAA submissions and/or inspections)
- Experience in technology transfer, process development and/or process validation
- Knowledge of Biologics DS/DP manufacturing, process validation, specification setting, control strategy setting, regulatory submission authoring
Responsibilities
- Provide clearly defined Quality expectations, Quality strategy, and Quality deliverables for the assigned program(s) within the Vertex product portfolio
- Develop, approve, and maintain critical Quality standards and control requirements for products and processes
- Critically evaluate new products and processes with respect to Quality and compliance requirements
- Proactively identify Quality risks and improvement opportunities for the assigned program(s) across all stages of manufacturing
- Ensure significant Quality risks are escalated per the company procedure and properly mitigated in a timely manner
- Champion a consistent approach to Quality and compliance standards as they relate to product
- Act as a project manager within Quality for the assigned project, ensuring and facilitating effective multi-directional communication between the Quality groups and cross-functional teams
Other
- Bachelor’s or Master's degree in a Scientific/Technical/Business discipline
- Minimum of 10 years of deep and broad experience in a technical, quality, and/or regulatory role within the pharmaceutical/biopharmaceutical industry
- Minimum of 5 years of leadership experience in directly managing staff and/or leading cross-functional teams, projects, programs, or directing allocation of resources
- Proven leadership ability to carry out difficult decisions in a logical, rational manner, and demonstrated ability to work as a senior management team member
- Demonstrated influential leadership experienced in operating in a matrix organization
