Director, Software Validation - Remote, US
About The Position
At Slipstream IT we work to streamline IT Support and provide managed solutions with a strategic consulting and global leadership management approach. Our solutions are designed exclusively for emerging pharma and biotech organizations. Slipstreams industry-leading solutions free clients from the demands of internal IT and allow them to rapidly advance their mission. Led by a leadership team that has been together for over 10 years, you will join a proven team, culture, and strategy to drive innovation within the IT outsourcing industry while developing your skillset with the opportunities for internal growth. Job Summary The Director, Software Validation, is responsible for establishing, maintaining, and continuously improving the companys Computer System Validation (CSV) program in alignment with applicable regulatory requirements, corporate quality policies, and industry best practices. This includes oversight of validation activities for all GxP-related computerized systems used in manufacturing, laboratory, clinical, and quality operations. Regulatory & Standards Scope This position ensures compliance with: GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems. 21 CFR Part 11: Electronic Records; Electronic Signatures. EudraLex Volume 4 Annex 11: Computerized Systems. FDA Guidance on Data Integrity and Compliance With CGMP. FDA Draft Guidance on Computer Software Assurance (CSA). Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), and Good Laboratory Practice (GLP). ICH E6 (R2) Good Clinical Practice Guideline.
Requirements
- Bachelors or Masters in Computer Science, Engineering, or Life Sciences.
- Minimum 10 years of progressive CSV experience in a GxP-regulated environment.
- Demonstrated expertise with GAMP 5, 21 CFR Part 11, Annex 11, FDA Data Integrity guidance, and CSA.
- Strong working knowledge of GMP, GCP, GLP, and ICH E6.
- Experience managing cross-functional global validation programs.
- Deep understanding of software development lifecycles and validation approaches.
- Exceptional leadership and team-building skills.
- Strong analytical, problem-solving, and decision-making abilities.
- Excellent written, verbal, and presentation skills.
- Ability to thrive in a fast-paced, regulated environment.
Responsibilities
- Develop and implement a global CSV and CSA strategy.
- Ensure alignment of CSV activities with company and regulatory requirements.
- Lead organizational readiness for evolving regulatory expectations.
- Create validation deliverables including plans, risk assessments, protocols, and reports.
- Ensure robust change control, periodic review, and system decommissioning processes.
- Promote adoption of risk-based validation methodologies.
- Serve as primary SME for CSV and data integrity during audits and inspections.
- Lead remediation of any validation-related findings.
- Maintain documentation and metrics to demonstrate compliance.
- Partner with Quality, R&D, and Clinical Operations in execution of CSV activities.
- Provide CSV training and mentoring to internal teams.
- Build, develop, and lead a high-performing validation team.
- Ensure adequate resourcing for current and future validation projects.
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What This Job Offers
Job Type
Full-time
Career Level
Director
