Sr. Manager, Quality CSV

Genetix Biotherapeutics•Somerville, MA

4d•$170,000 - $180,000•Hybrid

About The Position

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.

Requirements

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.

Nice To Haves

Hands-on experience with Veeva Vaults preferred.

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.