Sr. IT Analyst, Cell and Gene Therapy Quality

Job Description

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.

Key Duties & 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 withpeers 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.

Required Education Level

• Bachelor's degree in Computer Science, software engineering or other related technology degree

Required Experience

• 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

Required Knowledge/Skills

• 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.

Other Requirements

• Nice to have: Veeva QMS experience
• Nice to have: SNOW QRM experience
• Nice to have: Cell and Gene Therapy experience
• Nice to have: CGMP Quality exposure
• Nice to have: Technical writing experience

Pay Range:

Disclosure Statement:

Flex Designation:

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.

#LI-Hybrid

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