The Director of GMP Operational Quality is the Small Molecule Manufacturing Site Quality head. The Director role provides strategic leadership working closely with Site Head to achieve the corporate and strategic goals to support clinical and commercial manufacturing, continuous improvements and maintain inspection readiness state of the facility. This role will maximize value, impact and delivery in assuring compliance, excellence in quality and readiness for future needs.
The Director of GMP Operational Quality will work closely with business stakeholders from Pharmaceutical Sciences and Commercial Manufacturing and Supply Chain as well as Internal Quality functions to deliver quality outcomes and operational excellence. This Director will be part of the Quality Leadership Team and will participate in management review.
This individual will report to the head of GMP Operational Quality and will work closely with other CMC LT members Supporting product development and commercialization. This individual will demonstrate Vertex Core Values, as well as model leadership phenotype instilling a culture of quality, engagement, development, and transparency.
The Director will be responsible for setting goals, budget setting and monitoring and people development to establish strong team.
Key Duties and Responsibilities:
Directs teams responsible for internal quality commercial and development operations in support of GMP manufacturing and testing activities, including disposition responsibilities of material produced internally at the Vertex Manufacturing Center (VMC)
Drives compliance initiatives and continuous improvements in collaboration with the VMC Site Management Team
Enables strategic enhancements in alignment with the Senior Quality Leadership Team
Ensures Quality team performs and approves root cause analysis and product impact assessments for investigations resulting from deviations and OOS
Ensures escalation of significant events and leads Material Review Board discussions, as necessary
Ensures Quality team assesses and approves change controls for processes, equipment and facilities
Assists with Change Control governance through leading site CCRB with integration into Commercial Advisory Board
Liaises with Inspection Management and Inspection Readiness to ensure successful preparation and execution of regulatory inspections
Provide support or assist with hosting or inspection support for partner and regulatory agency audits
Negotiates, monitors and maintains Quality Agreements with Contract Labs, Vendors, and Service Suppliers, where applicable
Supports development of Quality Metrics to drive process improvement activities
Leads and manages highly complex projects/teams within corporate objectives and project timelines
Participates in cross-functional projects in Quality expert role
Provides operational strategies to address compliance gaps or determines enhancements to cross-functional quality systems
Responsible for team goal setting in best pursuit of corporate, department and site goals
Mentors staff on quality and technical related areas
Responsible for team development
Assist Senior Leaders in Department budgeting and scheduling
Ensures spend remains within approved budgets
Key Leadership Skills:
Learn, Teach, Develop
Lead by example
Foster exceptional collaboration
Drive breakthrough results
Promote enterprise thinking
Key Technical Knowledge, Skills and Competencies
Broad and deep global health regulatory agency knowledge and experience across multiple GMP with current knowledge of industry trends and best practices for efficiency, compliance and effectiveness
Broad and deep operational and project management knowledge and experience
Demonstrated strategic planning and execution skills required
Proven ability to design/evolve and /or implement processes and KPIs that are fit-for-purpose manner enabling effectiveness and assessment of the health of the local QMS
Current knowledge of industry trends and best practices- for progressive quality management in a regulated environment
Developing individuals and teams; proven leadership capabilities within multi-level organization
Creative, innovative leadership experience complemented with strong change management experience, adaptability, resourcefulness
Excellent communication skills and a proven track record Influencing/building/promoting a culture of Quality and Excellence
Extensive exposure with multiple regulatory agencies across applicable GxPs during inspections
Operational Excellence experience with proven ability to lead improvement projects-Experience with Root Cause Analysis and other Operational Excellence experience, such as LEAN, DMAIC, Six Sigma
Strong problem solving and critical thinking skills, accompanied by Analytical thinking/Data Analysis skills required to make sound decisions
Education and Experience:
M.S. (or equivalent degree) and 5 +years of relevant work experience, or B.S. in a scientific or allied health field (or equivalent degree) and 10+ years of relevant work experience, or relevant comparable background
Professional association membership and participation preferred, not required (for example: RAPS; Lean Six Sigma training/certification; SQA; ASQ; DIA)
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. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at (see application details).