General position summary:
The Director is responsible for oversight of the Quality department supporting product development and analytical activities, technical development of personnel and ensuring quality of deliverables within their purview. The Director is recognized for technical expertise both within and outside of the organization. The Director is responsible for development and maintenance of relationships with CMO Quality organizations. The Director is also responsible for assisting with the strategic alignment of group or team goals with projects and activities and refining those projects and/or activities proactively.
The Director reports to the Sr. Director of GMP Operational Quality.
- Lead the Quality team with primary responsible with providing quality oversight and support to all product development programs at Vertex; support of external manufacturing at CMOs across all phases of development for starting material, drug substance, drug product intermediates, and drug product.
- Responsible clinical batch disposition. Ensure review of batch data, including batch records, deviations, and other quality systems as applicable to determine acceptability of product disposition
- Lead the Quailty team supporting Analytical activities including method qualification/validation, method transfer, establishing specifications and justification for specifications and stability protocols (clinical and commercial), data and reports. Also including laboratory release testing review.
- Negotiate, monitor and maintain Quality Agreements with CMOs and Contract labs, where applicable.
- Ensure CMO oversight is performed and performance is monitored for continuous improvement.
- Participate in Joint Development Committee meetings to ensure Quality issues are raised and addressed, as necessary
- Ensures quality staff performs and approves root cause analysis and product impact assessments for investigations resulting from deviations and OOS. Leads Material Review Board discussions, as necessary.
- Ensures quality staff assesses and approves change controls
- Ensure regulatory submissions align with filing strategy. Review and approve submission amendments.
- Develop Quality Metrics to support system and process improvement activities
- Leads and manages complex projects/teams within corporate objectives and project timelines
- Participates in cross-functional projects in Quality expert and leader role
- Provides strategies to address compliance gaps or determines enhancements to cross-functional quality systems
- Fosters the demonstration of the Vertex Phenotype and Core Values in others
- Provide Subject Matter Expert support or assist with hosting or inspection support for partner and regulatory agency audits
- Responsible for goal setting in best pursuit of corporate and department goals for self and staff
- Mentors to staff on quality and technical related areas
- Responsible for providing information to forecast budget and headcount needs. Responsible to ensuring spend remains within approved budgets.
- Master’s degree and 15 +years of relevant work experience, or Bachelor’s degree in a scientific or allied health field (or equivalent degree) and 20+ years of relevant work experience, or relevant comparable background
- Broad knowledge of GMPs including global expectations
- Strong leadership skills with the ability to thrive in a high throughput environment
- Ability to lead and manage projects/teams within corporate objectives and project timelines
- Successful in building/leading high efficiency teams
- Sucessful in mentoring people managers
- Project Management / Continuous Improvement
- Proficient in utilizing project management processes / tools to lead meetings, assist with project planning, and facilitate completion of tasks
Collaboration / Teamwork / Conflict Management
- Ability to understand and translate business needs
- Strong communication and influencing skills
Critical Thinking / Problem Solving
- Ability to evaluate quality matters and make decisions utilizing risk based approach
Knowledge in the following areas:
- Expert knowledge of global GMP requirements governing drug products (for various product types oral, sterile, gene editing, etc)
- Root Cause Analysis tools/methodology
- Sense of urgency- ability to act quickly/escalation process/transparency
- Ability to: drive results on time every time, maintain composure under pressure, take ownership and accountability for shared information
- Knowledge of applications, such as: OPM (Oracle), QDoCCs,Trackwise/Veeva, MS Office