Sr. Manager, Quality CSV

About Genetix Biotherapeutics

At Genetix Biotherapeutics every role has meaning, every team member is respected, and every day is a chance to make a difference. When you join Genetix, you're not just landing a new role, you become part of a company that's pursuing curative gene therapies to give patients and their families more days. We are doers, thinkers and collaborators who embrace and live by our values:

Our innovation is rooted in the diversity of our teams and results are achieved through cooperation and the integration of multiple viewpoints. This is personal and we approach every challenge with radical care.

SUMMARY

The Senior Manager, QA Computer System Validation (CSV) is responsible for QA oversight of the validation and compliance of GxP-regulated computerized systems ensuring they are implemented, maintained, and retired in accordance with global regulatory requirements, industry standards, and internal procedures. 

This is a full-time hybrid position (3 days a week) in our Somerville – Assembly Row, Massachusetts office.

RESPONSIBILITIES

• Collaborate with IT to ensure internal CSV processes and procedures are aligned to GAMP 5, 21 CFR Part 11, EU Annex 11, ICH Q9 (risk management), ICH Q10 (PQS), and FDA’s Computer Software Assurance (CSA) guidance.
• Provide QA oversight for new system implementations, upgrades, integrations, cloud/SaaS solutions, and decommissioning activities.
• Approve validation deliverables (validation/assurance planning, testing strategy, traceability, UAT, periodic review, and retirement/archival plan, risk assessments, protocols, reports).
• Ensure validated systems remain in a controlled state through change management, periodic review, deviation management, and CAPA.
• Drive the shift from documentation‑heavy CSV to risk‑focused CSA, maximizing testing on features that impact patient safety, product quality, and data integrity.
• Own the company’s Data Integrity program for computerized systems (e.g., ALCOA+, audit trails, access controls/segregation of duties, e‑signatures, backup/restore, business continuity/disaster recovery, data retention and archival).
• Serve as QA reviewer/approver of deviations, CAPAs, change controls and effectiveness checks.
• Support internal/external audits and inspections.

QUALIFICATIONS 

• Bachelors’ and/or master’s degree in computer systems, engineering or related field required.
• A minimum of 7 years of experience in the industry with 5 years of direct CSV experience in GxP environment.
• Thorough knowledge and experience with change control process.
• Prior involvement in regulatory inspections with strong inspection-readiness skills. 
• Strong analytical and critical thinking skills.
• Ability to work independently and handle multiple projects in a fast-paced environment.
• High attention to detail and commitment to data integrity.
• Collaboration and relationship-building across functional areas.
• Hands-on experience with Veeva Vaults preferred.

Genetix is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment.  All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status or any other applicable legally protected characteristics.