ABOUT THE ROLE
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 OPPORTUNITY
- We 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.
KEY RESPONSIBILITIES
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…