Senior Specialist, Operational Area Quality Cell and Gene

4 weeks ago

Boston, Massachusetts, United States Vertex Pharmaceuticals Incorporated Full time

Job Description

General/Position Summary
The Quality Specialist is recognized as an expert internally in the principles and application of quality assurance and compliance. The Quality Specialist coordinates GMP activities in support of clinical and commercial Drug Product disposition. This position reports to Manager GMP Quality - Cell & GeneThe quality role will closely partner with operational stakeholders and participate in associated governance for the successful planning and execution of operational quality. The successful candidate will be a key member of the Vertex Cell & Genetic Therapy Quality Team and the Virtual Product Team.Key Duties & Responsibilities
  • As part of the GMP Operational Quality group primarily responsible with providing quality oversight and support to Vertex Cell and Gene Therapy operations in the following key areas/activities; support of manufacturing operations across all phases of development and commercial, support of analytical laboratory, materials management, and facility/engineering groups.
  • Responsible for batch disposition activities. Review batch data, including batch records, deviations, in-process data, EM data, QC release testing and other quality systems as applicable to determine acceptability of product disposition.
  • Responsible for approval of COAs and product labelling.
  • Provide production floor support and provide guidance for GMP product quality and compliance for product release, including resolution of product quality investigations and quality issues of a significant nature, and provides direction for product disposition decisions including shipment.
  • Review and approval of manufacturing documents.
  • Responsible for GMP release of incoming material and components.
  • Supports drafting and revising Quality Agreements between CMOs/Suppliers and Vertex, as needed.
  • Provide QA support of change controls, GMP investigations and CAPAs. OOS and OOT investigations and ensuring appropriate CAP actions are identified.
  • Participate in compliance walkthroughs and help drive the closure of any observations.
  • Responsible for identifying risks and communicating gaps for GMP process/systems.
  • Responsible for identifying risks and communicating any gaps for quality processes optimization for area/equipment release, material disposition, quality systems etc.
  • Participate in continuous improvements of department processes.
  • Participate in inspection readiness and support activities.
  • Participate in process improvement initiatives (as necessary).
  • Act as a trusted advisor to the site by providing compliance guidance through collaborative review and working with the business owners to gain a better understanding of their needs and facilitate resolution of quality issue in a timely manner.
Required Education Level
  • Bachelor's degree in a biotech/ Lifesciences field.
  • Preferred Master's degree or relevant comparable background.
Required ExperienceMaster's degree with 2-3 years of relevant work experience, or Bachelor's degree in a scientific or allied health field with minimum 3-5 years of relevant work experience, or relevant comparable background.Required Knowledge/Skills
  • In-depth global regulatory agency knowledge and experience across GXP life cycle in Cell & Gene therapy and/or Biologics.
  • Experience in product life cycle from discovery to commercials product development
  • Broad understanding of regulatory environment (US and EU cGMP regulations/guidance including quality systems, compliance, and strategy.
  • Broad technical knowledge in Cell technology, aseptic manufacturing technology, analytical assays, cell & genetic therapies/Biologics processing, fill/finish, and testing.
  • Ability to lead improvement projects - experience 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
  • Strong leadership and an innate ability to collaborate and build relationships.

On-Site Roles

On-Site designated role, you will work five days per week on-site with ad hoc flexibility.

#LI-Onsite #ND-2


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.

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

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 Human Resources at

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