GxP IT Validation Lead
van den Boom & Associates · Full-time · Posted 2w ago
Our IT Services practice provides managed IT, cybersecurity, and regulated-industry compliance services to life sciences and biotech companies, from seed stage through public companies. We help clients implement technology, operate it reliably, and demonstrate that the controls supporting regulated work are effective.
The OpportunityWe are looking for an experienced, hands-on GxP IT validation professional who can lead validation engagements and help clients keep computerized systems in a validated, inspection-ready state.
You will personally scope, write, execute, and document risk-based validation work for SaaS and cloud applications, computerized systems, and supporting IT infrastructure. You will work closely with client Quality Assurance (QA), system owners, and our IT delivery team to establish intended use, assess risk, and produce clear, defensible validation records.
Client QA retains approval authority for validation deliverables and GxP change decisions. You lead execution, recommend the appropriate scope, and explain the technical rationale.
This role offers a path toward broader technical and practice leadership as the service grows. The initial priority is excellent validation delivery and ongoing GxP IT compliance. Prior experience building a consulting practice or managing a department is welcome but is not required.
Lead validation engagements
Define intended use, system boundaries, GxP impact, and risk-based validation scope with client QA and system owners.
Prepare and execute validation plans, requirements, risk assessments, test protocols, traceability records, and summary reports appropriate to each system and its intended use.
Apply risk-based CSV and applicable computer software assurance principles, using supplier documentation and testing where justified.
Assess SaaS and cloud systems used in regulated work, such as eQMS, eSignature, LIMS, eTMF, and document management platforms.
Assess Microsoft 365 or SharePoint configurations when clients intend to use them for GxP records or workflows.
Plan and document qualification of supporting IT infrastructure, including relevant server, network, cloud, backup, and disaster recovery capabilities, in collaboration with technical specialists.
Explain validation decisions and resolve review comments with client QA.
Maintain the validated state
Maintain system inventories, validation status records, and scheduled review activities for assigned clients.
Assess changes, vendor releases, and system updates for GxP impact and recommend proportionate testing and documentation.
Perform or coordinate periodic reviews, supplier assessments, and audit trail reviews within the agreed scope and client-approved procedures.
Assess electronic record and signature controls, access management, audit trails, retention, and data integrity against applicable requirements and intended use.
Identify gaps, document risks, and track agreed remediation actions with accountable owners.
Support audits and inspections
Prepare validation records and IT control evidence for client QA reviews, sponsor audits, supplier audits, and regulatory inspections.
Explain work you have performed and the rationale supporting validation scope and testing decisions.
Support responses to observations and follow remediation actions through closure.
Escalate compliance concerns, delivery constraints, and unresolved risks promptly.
Improve delivery
Maintain practical SOPs, templates, and validation methods that support consistent, risk-based delivery.
Estimate effort for validation engagements with practice leadership.
Coordinate assigned work with IT engineers, compliance staff, and specialist consultants.
Provide technical guidance and review work within your area of expertise.
Help train IT staff on the GxP procedures relevant to their assigned work.
Track delivery effort and identify opportunities to improve quality and efficiency.
Practice leadership retains responsibility for commercial pricing, sales commitments, staffing decisions, and overall service portfolio ownership. This role may support SOX ITGC or SOC 2 engagements within demonstrated competence, with specialist involvement coordinated by practice leadership. These areas are secondary to the role's GxP validation responsibilities.
QualificationsRequired
Substantial hands-on experience in GxP computerized system validation or IT quality within life sciences. Typically seven or more years of relevant experience, with demonstrated delivery capability carrying more weight than a specific tenure threshold.
Personal ownership of validation engagements, including authoring deliverables, executing or coordinating testing, resolving QA comments, and completing approved validation packages.
Practical knowledge of 21 CFR Part 11, EU Annex 11, GAMP 5, data integrity principles including ALCOA+, and risk-based validation and assurance methods.
Experience validating regulated SaaS, cloud-hosted applications, or other computerized systems, with an understanding of the supporting IT infrastructure and shared responsibilities.
Ability to distinguish GxP impact, intended use, and system risk, and translate those judgments into a justified validation approach.
Experience maintaining validated systems through change control, release assessments, or periodic reviews.
Experience supporting a QA review, sponsor audit, supplier audit, external audit, or regulatory inspection involving computerized systems or IT controls.
Strong technical writing, client communication, and organizational skills, with the ability to manage several concurrent assignments.
US work authorization and residence in the United States.
Preferred
Consulting or managed-services experience supporting multiple life sciences clients.
IT infrastructure qualification experience involving cloud platforms, servers, networks, or backup and recovery.
Experience with Microsoft 365, SharePoint, Azure, Veeva, MasterControl, or comparable regulated platforms.
Direct participation in an FDA or other health-authority inspection.
Familiarity with SOX IT general controls or SOC 2 readiness.
Experience estimating engagements, mentoring colleagues, or leading validation programs.
Relevant quality, validation, or IT audit credentials.
Assigned clients have a documented system inventory, clear validation status, and agreed priorities for any gaps.
Validation work is completed to an agreed scope and schedule, with clear documentation accepted through client QA review.
Periodic reviews, change assessments, and other assigned recurring activities are completed on schedule, with exceptions documented and escalated.
Audit and inspection requests receive timely, accurate evidence and clear explanations.
Identified risks and findings have accountable owners, agreed actions, and tracked follow-through.
Reusable templates and delivery methods improve consistency without adding unnecessary documentation.
Delivery effort is recorded accurately so leadership can plan capacity and price work appropriately.
Client QA approves validation deliverables and GxP change decisions. We execute and recommend.
Approval responsibilities are assigned to preserve appropriate independence. No one approves their own change.
Client information remains confidential and separate from other clients' records.
Work is assigned according to demonstrated competence, with specialist support and escalation when needed.
We favor clear, proportionate controls and defensible evidence that fit each client's regulated activities.
vdB&A is an equal opportunity employer. We welcome and consider qualified applicants regardless of race, religion, gender identity, sexual orientation, disability, or any other status protected by applicable law.
New Zealand