Senior Director, Operational Quality - Cell & Gene Therapy (Onsite)

Job Description

The Senior Director of Quality Operations/ Site Quality Head CMC CGT provides strategic and operational leadership for all quality-related activities at the Cell & Genetics manufacturing site.The role is responsible for the build out of a phase appropriate quality roadmap from clinical through commercialization of the CGT product to meet business, regulatory and operational requirements. Responsibilities include effective leading of the quality operation team across multiple shifts to maintain oversight of product quality, improve GMP processes and assure compliant manufacturing operations .

Key Duties and Responsibilities:

• Establishment of quality oversight for internal quality operations, from research to commercial stage including manufacturing and distribution of product globally.

• Represent Quality in Cell & Genetic Programs and serve as a trusted advisor and partner to establish the CMC quality strategy and roadmap for innovative therapeutic programs.

• Establish and lead GxP Cell & Gene Therapy Management Reviews to gain insights regarding efficiency and operational performance across the GXP operations, including identification of opportunities for improvement and associated actions.

• Support/lead risk management activities, including mitigation plans and associated execution.

• Provides quality leadership and management for the oversight of compliant and effective production controls, including but not limited to the quality oversight of internal manufacturing operations, aseptic processing, materials management and quality control.

• Establish and maintain robust quality systems, including SOPs(Standard Operating Procedures), policies, and procedures for site internal quality operations.

• Effectively maintains quality oversight of production controls to assure compliant practices, identifies opportunities for improvement and drives effective resolution and mitigation with business partners.

• Monitors regulatory and external intelligence for best practices, emerging trends and projection of future capabilities requirements to support Cell & Genetic Therapies quality operations and programs. .

• Quality oversight of site operational readiness for regulatory inspections, internal audits and commercial operations. Works closely with the cross- functional partners to prepare for and support Health Authority inspections, and ensures appropriate corrective and preventative actions are implemented.

• Represent C&G Quality to lead/participate in complex projects and partner with key stakeholders for alignment in strategic and operational planning and delivery of business & financial priorities and goals.

• Create and foster a culture of collaboration, development, and engagement for advancing quality outcomes and operational excellence.

• Lead and mentor team members, support development of organizational capabilities and talent building.

Knowledge and Skills:

Education and Experience:

• Bachelor's degree in an engineering/Lifesciences field.

• Master's degree or relevant comparable background.

• Typically requires 15+ years of onsite relevant industry experience in quality assurance operations

• A minimum of 10 years leadership experience leading teams or directing allocation of resources is preferred. Previous experience on a Site Leadership Team is strongly preferred

#LI-AR #LI-Onsite

Pay Range:

Disclosure Statement:

Flex Designation:

Flex Eligibility Status:

In this Hybrid-Eligible role, you can choose to be designated as:
1. Hybrid: work remotely up to two days per week; or select
2. On-Site: work five days per week on-site with ad hoc flexibility.

Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time.

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.

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 ApplicationAssistance@vrtx.com