General/Position Summary
The Director, Quality Assurance GMP Operations is responsible for the applicable Cell & Gene CDMO and is responsible for the end to end quality oversight of all product and activities at the CDMO. Responsibilities include day-to day operational quality oversight including assuring progression of batch record operations, resolution and on time disposition of product, quality continuous improvements, changes associated with the process and associated implementation, trends, and overall quality performance of the CDMOs.

The role will closely partner with operational stakeholders to lead/support the development and execution of quality & technical risk mitigation, execution of operational activities and participation in governance committees. A key expectation is the ability to closely collaborate and build relationships with internal and external stakeholders to drive compliance and continuous improvement activities. The role may also be required to support on site manufacturing activities at the CDMO.

Key Duties & Responsibilities

• Establishment of quality oversight for external CTO/CDMO operations including assurance of on time of batch disposition process, across development, launch and commercial manufacturing globally.
• Lead, Develop, and implement continuous quality improvements to advance quality outcomes and operational excellence in processes.
• Proactively develop Compliance metrics as key indicators and takes action to mitigate.
• Maintain full oversight of CDMO QMS including driving deviation reduction and assuring timely resolution of CAPAs.
• Act as the SME for the CDMO, understanding scope of all changes, driving applicable global change control implementation with the external manufacturing partner to meet global product goals.
• Represent Quality and serve as a trusted partner for the disposition activities of drug product.
• Build strategic relationships and foster a culture of collaboration with internal and external partners – CDMOs and CTOs within the Quality organization to ensure Quality issues are raised and addressed, as necessary.
• Lead/support the development of quality & technical risk mitigation through identification and mitigation compliance gaps.
• Lead and mentor other team members, support development of organizational capabilities and talent building.
• Act as the batch disposition subject matter expert (SME) in support of regulatory inspections and audits.
• Establish/participate 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.
• Work closely with the cross- functional partners to prepare for and support Health Authority inspections, respond to information requests, adjudicate compliance discussions, and negotiate any required corrective actions.
• 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.
• May be required to support manufacturing on site activities.

Required Education Level

• Batchelor's degree or relevant comparable background.
• Masters preferred.

Required Experience
10+ years of experience and 5+ years in a management/supervisory role, or the equivalent combination of education and experience in a regulated pharmaceutical environment

Required Knowledge/Skills

• In-depth global health regulatory agency knowledge and experience across GXP life cycle in Cell & Gene therapy and/or Biologics (EU GMPs, FDA 21CFR Part 1271, GxPs).
• Broad and current knowledge of batch disposition industry trends and best practices in Cell/Gene therapies.
• Preferred QA Operational experience for Autologous Cell Therapy Operations.
• Broad technical knowledge in Cell technology, aseptic manufacturing technology, analytical assays, cell & genetic therapies/Biologics processing, fill/finish and testing.
• Demonstrated strategic planning and execution skills required for operational effectiveness and compliance. Proven ability with Root Cause Analysis, data analytics, and other Operational Excellence experience, such as LEAN, DMAIC, Six Sigma.
• Excellent communication skills and a proven track record Influencing/building/promoting a culture of Quality and Excellence.
• Ability to apply risk management principles to decision making and operational priorities.
• Critical Thinking and Problem Solving skills
• Ability to closely collaborate and build relationships with internal and external stakeholders.

Other Requirements
Up to 25% Travel may be required

Flex Designation:
Hybrid-Eligible Or On-Site Eligible

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.

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.