Vertex Pharmaceuticals

Vertex Pharmaceuticals

Associate Director, Manufacturing Process and Technical Quality Assurance Cell and Genetic Therapies - VCGT

Boston, MA · Director

Sponsorship not specified$157k-$235kDetected 5 hours ago
Data AnalysisData VisualizationProduct ManagementSupply ChainRecruitingFDA RegulatoryCRISPRCommunicationProblem SolvingCritical ThinkingGxPRegulatory Affairs

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odds of building a lasting career here

59Sponsors, lottery-bound
Cap-exempt (no lottery)0
Sponsors this role82
Entry-level history0
PERM / green-card track0
Lottery odds (Level IV)94
Fits your clock70

Sponsors, but it's cap-subject — you still face the weighted lottery (~61% per draw at Level IV). Good if you win; have a cap-exempt backup on your list.

Lottery odds assume a STEM candidate.

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H-1B wage level

the lottery is wage-weighted — each level is one more entry

Level IV · 4×
Level I$72,2801 entry
Level II$94,7862 entries
Level III$117,2913 entries
Level IV$139,7974 entries

This range already reaches Level IV — the maximum four lottery entries.

DOL prevailing wage, 2026-27 wage year · Software Quality Assurance Analysts and Testers (15-1253) · Boston-Cambridge-Newton, MA-NH. Wage level is derived by USCIS from the offered wage, occupation and worksite; the occupation shown is inferred from the job title.

Employer immigration record

from this employer's Department of Labor filings

Green-card follow-through: 83%

Of 12 labor certifications old enough to have been used, 2 expired without the employer filing the next step. Median time from filing to decision: 515 days.100% of their filings were for a worker who already held the job.Only certifications past the 180-day window are counted — recent ones cannot have expired yet.

Files H-1B transfers

29 transfer filings in the last year, covering 29 workers. Median labor-condition decision: 7 days. An employer that already files transfers is one that can take over an existing H-1B.

Sourced from Department of Labor LCA, PERM and prevailing-wage disclosure data. Employer matching is by name, so figures may be split across an employer's legal entities. Absence of a filing means none appears in our copy of the data, not that none exists.

Community outcomes

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About the role

  • The Manufacturing Process & Technical Quality Associate Director provides end-to-end l quality oversight for cell and gene therapy programs across clinical development, commercialization, product launch, and post-approval lifecycle management.
  • Serve as the Quality representative on CMC Governance forums to ensure compliant lifecycle strategies, technical transfers, and manufacturing changes.
  • Provide Quality oversight and strategic partnership for internal manufacturing operations and external contract manufacturing organizations (CMOs) supporting product lifecycle activities.

Responsibilities

  • Lead QA review and approval of stage-gate deliverables, process development activities, technology transfers, process validations, and new product introductions across the product lifecycle.
  • Drive the development, implementation, and maintenance of quality and compliance frameworks, standards, and strategies to ensure products and processes remain aligned with evolving regulatory and industry CGT expectations.
  • Partner with Development, Technical Operations, Manufacturing, and Supply Chain functions to support continuous improvement initiatives throughout development to commercialization.
  • Lead and/or support quality review of complex investigations, deviations, change controls, risk assessments, and compliance issues impacting product quality or manufacturing processes.
  • Partner with cross-functional teams to identify product, process and quality and compliance risks, assess impact, and implement appropriate mitigation strategies.
  • Support development of Vertex quality systems and processes.
  • Identify, facilitate, and/or lead continuous improvement efforts
  • Support implementation of standardized quality practices, lifecycle management strategies, and continuous improvement initiatives across internal and external manufacturing networks.

Requirements

  • Ability to lead improvement projects. experience with Root Cause Analysis, data analytics, and other Operational Excellence experience.

Skills

  • In-depth global regulatory agency and technical knowledge and experience across GXP QA and QC activities in cell therapies
  • Experience with platforms such as MES, LIMS, eQMS, data visualization tools, and advanced analytics is preferred.
  • Critical Thinking and Problem Solving skills
  • Education and Experience:
  • Bachelor's degree in a scientific or allied health field (or equivalent degree)
  • Preferred additional Master's degree at Business /Scientific level
  • 8+ years of experience, or the equivalent combination of education and experience in a regulated pharmaceutical environment.

Compensation

  • $156,600 - $234,800
  • 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.

Benefits

  • Support preparation and review of process-related specifications, development reports, validation documentation, and regulatory submissions, including responses to Health Authority inquiries.
  • Support inspection readiness activities and participate in Health Authority inspections, regulatory interactions, information requests, and corrective action commitments.

Company info

  • work remotely up to two days per week; or select
  • work five days per week on-site with ad hoc flexibility.
  • 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
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This listing is sourced directly from Vertex Pharmaceuticals's careers page and normalized into a canonical job model.