Director, Manufacturing Operations Compliance, Cell Therapy Quality

Job Description

General/Position Summary

The Director, Manufacturing Operations Compliance, Cell Therapy Quality as part of the Vertex Quality Assurance Organization is responsible for the operational compliance of CMC activities of the internal manufacturing site for Cell & Gene. This role will be responsible for the oversight of operational site compliance and maturity including site compliance activities, and operational compliance readiness. The role is responsible for the compliance oversight, identifying gaps and risks, driving mitigation of such risks and supporting cross-functional partners in ensuring execution.

Vertex is an exciting, fast paced dynamic environment with a strong company culture focused on patients with unmet medical needs. The ideal candidate is someone with significant experience in establishing manufacturing site compliance oversight, operational inspection programs from development to commercial and successfully executing to maintain a constant inspection readiness site.

This is a Cell & Gene manufacturing site based role located in the Boston Seaport.

Key Duties & Responsibilities

• Serves as manufacturing site CMC Compliance Lead with responsibility for the overall strategic direction, oversight, performance and effectiveness of the site compliance as well as operational inspection readiness program. This includes site self assessments, gamba walks and overall continuous compliance improvements.
• Responsible for identification of compliance gaps/risks, drives alignment on mitigation and assures action execution to closure.
• Develops and implements strategies for operational readiness, including mock inspections, and site preparation.
• Partners with the QA Operations and cross-functional leadershipin ensuring overall operational execution, readiness and site maturity program.
• Collaborating with cross-functional teams to develop and implement effective corrective and preventive actions (CAPAs) in response to audit and inspection findings.
• Collaborates with the Global Quality Audit and Inspection Management to enable execution and maturity of site for pre-approval inspection and other inspection readiness.
• Monitoring and analyzing key performance indicators (KPIs) related to internal audits, inspections and compliance, external intelligence for CGT regulatory inspections, and identifying areas for improvement.
• Communicates status, risks, and escalations with management through governance forums and ongoing report outs.
• Leads/Engages/Support in Quality projects ensure successful planning, execution and on-time delivery.
• Ensure activities and deliverables are in compliance with Global HA regulations, Vertex SOPs and industry best practices.
• Provides functional area leadership and management through the execution of Goals, Employee learning and development, and budget forecasting.

Required Education Level

Bachelor's degree in a Scientific/Engineering/Lifesciences field.

Required Experience

Typically requires 12+ years of relevant industry experience in a commercial manufacturing site in biotechnology/regulated pharmaceutical environment.

Required Knowledge/Skills

• In-depth GxP experience with current knowledge of industry trends, HA regulations & expectations, and best practices
• Extensive knowledge of commercial readiness, with CMC inspection operational readiness, leading regulatory authority inspections at a manufacturing site
• Broad knowledge of Cell & Gene therapy and/or Biologics, aseptic manufacturing processing.
• Ability to lead improvement projects - experience with Root Cause Analysis, data analytics, and other Operational Excellence experience, such as LEAN, DMAIC, Six Sigma
• Strong leadership skills with the ability to organize and execute tasks effectively.
• 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.
• Ability to manage multiple projects, work in a dynamic environment and communicate effectively with senior leaders.

Other Requirements

5% travel may be required.

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Pay Range:

Disclosure Statement:

Flex Designation:

Flex Eligibility Status:

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