Associate Director, GMP Quality CGT Personalized Medicine

Job Description

Position Summary

The Associate Director,  GMP Quality, CGT Personalized Medicine supports strategic design of and ensures tactical execution of quality systems, risk management, and quality culture across the Vertex Cell and Gene Therapy (VCGT) organization. The role is responsible for partnering with cross-functional technical development and commercial teams to align and facilitate harmonization of strategy, procedures and processes related to the CGT specific processes within the global Quality Management System and to drive Quality improvements. 

This position reports directly to the Director of Quality, CGT. 

Key Duties & Responsibilities

The responsibilities of this position may include, but are not limited to, the following:

Quality Systems for Personalized Medicine

• Partner with business and Quality system owners and digital stakeholders to provide and ensure Quality personalized medicine /advanced therapies CGT user requirements are embedded in lifecycle management projects from design through implementation and sustainment.

• Establish compliance governance routines to proactively monitor compliance trends, operational performance, operational readiness, and emerging risks that may impact product quality, patient safety, supply continuity, or program execution

• Collaborate with internal and external business partners to resolve complex quality issues to ensure compliant solutions 

• Lead the monitoring, interpretation, and communication of QMS processes and metrics requirements including remediation plans

Process Lead for VCGT Change Management operations for Life Cycle Management 

• Drive the VCGT process execution and problem-solving exercises with cross-functional stakeholders to address process constraints and challenges. 

• Partner with Life Cycle Management QA and cross-functional stakeholder, Manufacturing Science and Technology, Disease Area Lead to enable delivery of strategic change plans by leveraging quality expertise, system knowledge and effective communication.

• Execute end-to-end process improvement across clinical, launch, and commercial lifecycle stages in support of personalized medicine/advanced CGT programs, enhancing decision making practices, operational tools, governance and escalation

• Provide feedback and support to Quality System Owner to identify and implement enhancements to support the VCGT process and overall where applicable system improvements.

Process Lead for VCGT Data Integrity (DI) program 

• Collaborate with Global Process Owner and Operational Stakeholders to define and deploy DI compliance operational strategy at the local site level, including participating in the applicable governance, risk mitigation and reporting outcomes to Senior Leadership.

• Apply expertise of Standards and Guidances to assess and guide day-to-day operations with the management of data and investigations into causes of Data Integrity failures. 

Compliance & Continuous Improvement

• Oversee CGT Quality Systems responsibilities to improve compliance visibility, efficiency, data integrity, process robustness, maturity, and scalability across quality events, change management, risk management, CAPA, and management review.

• Work to enhance Quality Culture across VCGT organization and lead continuous quality improvement initiatives and process enhancements to improve performance, compliance, reduce recurring issues, and strengthen proactive quality management.

• Partner with Global Quality and cross-functional stakeholders to support development and deployment of advanced digital reporting solutions and use of artificial intelligence in CGT and enable transparent governance, decision-making, and escalation of quality and operational risks.

Required Education Level

• Bachelor's degree in a scientific discipline, operations research, operations management, business administration or a related field

Required Experience

• Requires 8+ years of experience or the equivalent combination of education and experience 

• Experience in product life cycle from discovery to commercial product development 

Required Knowledge/Skills

• Broad and deep expertise in global GMP regulations, guidances, and Quality Management as well as a strong understanding of industry standards and best practices across the GxP lifecycle 

• Strong leadership skills with ability to be agile and effectively collaborate in a dynamic, cross-functional matrix environment 

• Ability to lead and manage complex projects/teams within corporate objectives and project timelines 

• Proficiency utilizing project management processes / tools to lead meetings, assist with project planning and facilitate completion of tasks 

• Excellent technical writing, presentation and communication skills 

• Ability to effectively influence others within technical area of expertise 

• Outstanding facilitation, communication, and coaching/influencing skills 

• Ability to navigate through ambiguity and rapid growth and adapt to change 

Other Requirements

Up to 5% travel

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. 

#LI-Hybrid
 

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