Job Description

General/Position Summary

The Director, CMC Inspection Management as part of the Vertex Quality Assurance Organization is responsible for the inspection management related to CMC activities of the internal manufacturing site for Cell & Gene. This role will be responsible for the development of an inspection program for site compliance and maturity, inspection preparation, consistent state of readiness and inspection management. The role is responsible for designing the program, identifying risks, driving mitigation of such risks and supporting cross-functional partners in ensuring execution.

Additional responsibilities include support for external site inspection readiness. 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 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 Inspection Lead with responsibility for the overall strategic direction, oversight, performance and effectiveness of the site inspection program.
• Responsible for identification of compliance gaps/risks, drives alignment on mitigation and assures action execution to closure.
• Develops and implements strategies for inspection readiness, including mock inspections, training, and site preparation visits.
• Partners with the site QA leadership and cross-functional leadership for coordination and alignment in ensuring overall execution, readiness and site maturity adequacy.
• 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, 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 inspection planning/coordination and management for 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.

#LI-onsite

Pay Range:

Disclosure Statement:

The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.

At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.

Flex Designation:

Flex Eligibility Status:

In this On-Site designated role, you will 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