Director, GMP Quality

Job Description

General Summary:

The Director, GMP Operational Quality is responsible for oversight of Development Quality team activities, technical development of personnel and ensuring the quality of deliverables within role's purview. The Director is responsible for development and maintenance of relationships with internal business partners, CMO Quality organizations and Qualified Persons. The Director is recognized for technical expertise and assists with the strategic alignment of group and department goals with projects and activities, refining and adapting as necessary through proactive monitoring/measurement.

Key Duties and Responsibilities:

o 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, drug product and finished goods.

o 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

o Oversees execution of program risk and stage review activities

o Negotiate, monitor and maintain Quality Agreements with Partners, CMOs, Contract labs, Vendors, where applicable

o Monitors CMO oversight activities and assesses for continuous improvement.

o Participate in Joint Development Committee to ensure Quality issues are raised and addressed, as necessary

o Ensures quality staff performs and approves root cause analysis and product impact assessments for investigations resulting from deviations and OOS

o Leads Escalation Action Committee and Material Review Board discussions, as necessary

o Ensures quality staff assesses and approves change controls for commercial processes

o Ensure regulatory submissions align with filing strategy; review and approve submissions amendments

o Support development and maintenance of Quality Metrics to support process improvement activities

o Leads and manages highly complex projects/teams within corporate objectives and project timelines

o Participates in cross-functional projects in Quality expert role

o Provides operational strategies to address compliance gaps or determines enhancements to cross-functional quality systems

o Provide support or assist with hosting or inspection support for partner and regulatory agency audits

o Collaborates with in house Quality counterparts, business partners, and with CMOs and Qualified Persons

o Responsible for team goal setting in best pursuit of corporate and department goals

o Mentors to staff on quality and technical related areas

o Fosters the demonstration of the Vertex Leadership Behaviors and Core Values in others

o Assist management team in budgeting and scheduling

o Ensures spend remains within approved budgets

o Responsible for individual and team development

Knowledge and Skills:

o Expert knowledge of both the conceptual and practical application of cGMPs in support of development of products to commercialization

o Demonstrated success in building high-performing teams and skilled at managing team and individual development

o Highly effective management skills with the ability to lead and motivate a team in a fast-paced environment while maintaining a high degree of quality, accuracy and timeliness

o Substantial background in managing complex projects/teams within stated objectives and timelines and with a strong understanding of the underlying business drivers; skilled at applying project management processes / tools to lead meetings, assist with project planning, and facilitate attainment of project objectives

o Expertly lead cross-functional teams and represent the interests, strategies and objectives of Quality unit

o Substantial skills in mentoring staff and transferring technical knowledge to enable their capabilities and development

o Ability to communicate cross-functionally to a wide variety of audiences; exchanges complex concepts with the ability to influence leaders, customers, or vendors to adopt of a new point of view and/or to take action; negotiation skills may be required

o Demonstrated ability to evaluate unusually complex quality or multi-disciplinary matters and make decisions utilizing risk-based approach; identifies and leverages the appropriate expertise to implement solutions

o Extensive experience successfully leading event investigations, Root Cause Analysis (RCA), and CAPA

o Extensive exposure with multiple regulatory agencies across applicable GxPs during inspections

o Knowledge of applications, such as: Oracle, QDoCCs, Veeva, MS Office, Airtable

Education and Experience:

o Bachelor's degree in a scientific or allied health field (or equivalent degree)

o Typically requires 10 years of work experience and 3 years of management experience, or the equivalent combination of education and experience

Company Information

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.

Please note that Vertex requires COVID-19 vaccination for all employees working in the U.S. as a condition of employment at Vertex, subject to medical, religious or other accommodations or exemptions required by law. We believe this requirement is vital to keeping everyone at Vertex and in our communities safe. This requirement applies to both existing and new employees who may at any time work on-site at a Vertex facility or visit another location on behalf of Vertex (e.g., conferences, customer visits, etc.), including all remote employees. 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).