The Associate Director will be responsible for leading the day-to-day Quality operations at the VCGT device manufacturing site. The role will also be a key contributor to the implementation and execution of VCGT quality systems including oversight of the Providence facility and equipment validation activities. The Associate Director will also be responsible for the implementation of policies, practices, procedures, standards, and systems necessary to ensure the compliance of site operations to global GMP regulations. The Associate Director is recognized for technical expertise both within and outside of the organization. The Associate 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 Associate Director reports to the Sr. Director of VCGT GMP Operational Quality.
- Lead Device Quality Assurance strategy and efforts including the design, development, review and approval of DHF records.
- 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
- Ensures quality staff performs and approves root cause analysis and product impact assessments for investigations resulting from deviations and OOS.
- Ensures quality staff assesses and approves change controls
- Ensure regulatory submissions align with filing strategy. Review and approve submission amendments.
- Ensures raw material risk assessments are performed per USP/ATMP guidance
- Coordinate Combination Device training
- Quality oversight of the environmental monitoring program for the Providence Site
- Quality oversight of Technical Transfers between site/site
- Be directly involved in and where appropriate, lead multiple process/product improvement projects which may include quality system process improvements, development of new methodologies and improving existing methodologies, data generation, report development and presentation
- Support audit readiness efforts
- Maintain a high level of expertise in current regulatory requirements and serve as a resource for compliance to these requirements
- Must be recognized as an expert in their area by all levels of the facility and be able to demonstrate leadership ability
- QA oversight of equipment/facility/utility validation and requalification program and validation master plan
- Provide Quality oversight of facility design, build and qualification
- Review protocols, data summaries, reports for validation and stability studies
- Perform risk assessments of new programs for entry into the GMP facility
- Monitor and interpret cGMP regulatory guidelines and trends in the breakthrough therapy regulatory space and incorporate into phase appropriate control strategies
- 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
- Bachelor's degree and 10 +years of relevant work experience in a scientific or allied health field (or equivalent degree) and 10+ years of relevant background in device or combination products
- Experience in providing quality oversight of facility design, build and qualification
- Demonstrated Quality leadership through a partnership approach with manufacturing to enable high quality and compliant product distribution to patients is required
- Demonstrated experience building and leading exceptional Quality Assurance, Quality Systems teams
- Expert knowledge of GMP, FDA and EMA regulatory requirements applicable to Device and/or Combination products
- Strong knowledge of current industry trends and has the ability to use the latest technologies
- Working knowledge of: Aseptic practices and clean room design/operations, auditing techniques.
- 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 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 device or combination products
- 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
Posting ID: 584153210Posted: 2021-02-21