Vertex Pharmaceuticals · 17 hours ago
Sr. IT Analyst, Cell and Gene Therapy Quality
Boston, MA
Full-time
Hybrid
Mid, Senior Level
$124K/yr - $186K/yr
5+ years expVertex Pharmaceuticals is a global biotechnology company that invests in scientific innovation, and they are seeking a Sr. IT Analyst for their Cell and Gene Therapy Quality team. This role is crucial for ensuring the quality and regulatory compliance of CGT systems, managing quality deviations, and driving continuous improvement initiatives.
BiotechnologyHealth CareMedicalPharmaceutical
Responsibilities
Own and manage quality deviations for CGT applications
Evaluate quality and compliance processes, leveraging quality management experience to make informed and complex decisions
Lead event investigations, Root Cause Analysis (RCA), and Corrective and Preventive Actions (CAPA) to address quality issues effectively
Manage the deviation lifecycle, including documentation activities, meeting coordination, facilitation, look-back analyses, risk assessments, and process improvements
Collaborate cross-functionally to triage quality events, gather required information from key stakeholders and perform required assessments on deviation
Communicate complex and time sensitive information to senior DTE stakeholders, enabling them to navigate and negotiate conversations with Quality leadership
Communicate with both internal and external stakeholders to gather quality event information and associated details needed for managing the quality event effectively
Influence business and quality stakeholders by aligning proposed actions on quality events
Utilize electronic document management systems (e.g., QDoccs, Trackwise, Veeva) to ensure accurate and timely documentation
Identify and address quality issues, gather relevant information, and align on CAPA strategies to enhance processes
Ensure adherence to Quality processes, SOPs and controls
Work in a fast-paced environment, meeting quality, accuracy, and timeliness objectives while fostering strong team collaboration
Build metrics and perform trend analysis on DTE quality events
Contribute to DTE change management based on the outcome of the quality events
Leverage strong communication and analytical skills, quality expertise to understand, document, assess, and drive corrective actions cross functionally
Achieve stakeholder satisfaction and engagement levels across various levels of stakeholders within the organization
Develop collaborative relationships with peers in IT, Quality, Vendor partners, and other teams to help manage quality events and change controls
Responsible for quality risk item management in the QRM portal
Coach and lead Vertex colleagues and manage service partners on the quality event contributions
Qualification
Required
Bachelor's degree in Computer Science, software engineering or other related technology degree
5+ years of relevant work experience
Knowledge in Quality Deviation Management and GxP compliance
Biotech or Pharmaceutical Industry Experience
Experience working with GxP IT systems, SaaS solutions and vendors
Experience with 21 CFR Part 11 CFR 21 regulations
Experience with stakeholder engagement, vendor management, and IT teams
Experience with Quality and Risk management portals
Software deviation and risk management expertise
Executive-level communication skills; ability to explain complex topics in a digestible way
Ability to drive continuous operational improvement
Proven ability to stay abreast of industry and regulatory trends
Exposure to GxP audits and inspections/FDA regulations
Exposure to GxP change management
Demonstrated ability to interpret system and quality requirements and assess quality events
Exceptional analytical and problem-solving skills with attention to detail
Flexibility to adapt to a continually changing and fast-paced business environment
Preferred
Veeva QMS experience
SNOW QRM experience
Cell and Gene Therapy experience
CGMP Quality exposure
Technical writing experience
Benefits
Medical, dental and vision benefits
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)
Company
Vertex Pharmaceuticals
Vertex Pharmaceuticals is focused on the discovery and development of small molecule drugs for the treatment of serious diseases.
5001-10000 employees
H1B Sponsorship
Vertex Pharmaceuticals has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (188)
2024 (150)
2023 (111)
2022 (164)
2021 (112)
2020 (80)
Funding
Current Stage
Public CompanyTotal Funding
$657.31MKey Investors
Janssen Belgium
2024-07-10Post Ipo Secondary· $1.11M
2022-05-17Post Ipo Equity· $50M
2009-12-03Post Ipo Equity· $443M
Leadership Team
Reshma Kewalramani
CEO and President
Nina Devlin
Senior Vice President, Chief Communications Officer
Recent News
2026-02-06
Pharma Letter
2026-02-04
Company data provided by crunchbase