Sr. IT Analyst, Cell and Gene Therapy Quality

Vertex Inc.•Boston, MA

21d•Hybrid

About The Position

At Vertex, quality is at the heart of everything we do, especially as we pioneer transformative advancements in Cell and Gene Therapy (CGT). The CGT Quality Lead is a critical member of our Data, Technology, and Engineering (DTE) team, ensuring that the Vertex Connects Portal for CGT systems and integrated applications meet the highest quality standards and regulatory compliance. This role is pivotal in safeguarding the integrity of our CGT applications by managing quality deviation life cycle processes, collaborating with Quality partners, and ensuring timely resolution of quality events. The CGT Quality Lead will play a key role in driving continuous improvement initiatives, leading investigations, and implementing corrective and preventive actions (CAPA) to uphold Vertex’s commitment to excellence. This position requires advanced judgment, the ability to synthesize complex information, and a proactive approach to problem-solving, making it essential to the success of our mission to deliver life-changing therapies to patients. This role has the potential to support broader technology initiatives expanding to different roles within DTE.

Requirements

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.

Nice To Haves

Veeva QMS experience
SNOW QRM experience
Cell and Gene Therapy experience
CGMP Quality exposure
Technical writing experience

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.