Associate Director GxP CSV

Job Title: GxP Computer Systems Validation (CSV) (Associate Director)
Company: Biopharma
Location: Boston, MA

Brio Resource Group is a Life Sciences Executive Search Firm committed to providing rare talent on an exclusive search basis to the Biopharma, Pharma, Device, and CRO industries. We work on behalf of organizations that value true talent acquisition partners and specialize in supporting emerging Biopharma companies offering life-changing therapies. Our many years of experience, subject matter expertise, comprehensive search process, and genuine passion to deliver rare talent defines Brio.

Position Overview:
We’ve partnered with a growing biopharma company seeking an experienced GxP Computer Systems Validation (CSV) leader to join their team. This critical position will be responsible for overseeing the CSV program and working closely with GxP departments to ensure compliance with regulatory expectations and internal procedures.

Opportunity Highlights:

  • Own and manage the CSV program, including writing, reviewing, and approving deliverables such as Change Controls, Plans, Specifications, Traceability Matrices, Test Scripts, and Reports

  • Lead the creation and revision of CSV procedures, forms, and templates for continuous improvement

  • Manage CSV-related Deviations and CAPAs, and oversee remediation efforts related to CSV and Data Integrity

  • Work closely with IT and System/Process Owners to maintain GxP computerized systems in a validated state

  • Establish and oversee audit trail review requirements, back-up/restore, disaster recovery, and retention schedules

  • Provide training for the CSV program to new System/Process Owners

  • Serve as CSV SME during audits and inspections and generate metrics for the CSV program

  • Stay informed on FDA Computer Software Assurance (CSA) principles and upcoming regulations

Position Requirements:

  • 5+ years of CSV experience in a pharmaceutical/biotech/medical device environment

  • Extensive knowledge of GxP regulations, CSV/CSA principles, including 21 CFR Part 11, Annex 11, GAMP 5, and Data Integrity

  • Experience with Quality Risk Management per ICH Q9 and its application to CSV

  • 8-10+ years of experience in a Quality Assurance (QA) role, preferably in a biopharma or related field

  • Bachelor’s degree in Computer Science or related discipline preferred

  • Proficiency in Microsoft Office, including process mapping/project management tools such as Visio and Project

  • Veeva and ERP/Clinical Data Management systems experience (e.g., Oracle, SAP) a plus

  • Excellent verbal and written communication skills

  • Attention to detail, accountability, and a results-oriented mindset

  • Ability to manage multiple projects and effectively resolve issues in a fast-paced environment

We welcome the opportunity to provide a full job description upon resume review.