Job SummaryThe Director, Software Validation, is responsible for establishing, maintaining, and continuously improving the company's 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 FDA Draft Guidance on Computer Software Assurance (CSA).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.
Key Duties & Responsibilities- Strategic Leadership 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.
- Operational Management 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.
- Compliance & Audit Readiness 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.
- Cross-Functional Collaboration Partner with Quality, R&D, and Clinical Operations in execution of CSV activities.
- Provide CSV training and mentoring to internal teams.
- Team Development Build, develop, and lead a high-performing validation team.
- Ensure adequate resourcing for current and future validation projects.
Education & Experience Requirements- Bachelor's or Master's 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.
Competencies & Skills- 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.
Work Environment & Travel- Primarily remote with periodic on-site presence as required in Hampton, NJ.
- Occasional domestic/international travel for audits, vendor assessments, or project support.
Hourly RateThis job description may not be inclusive of all assigned duties, responsibilities, or aspects of the job described, and may be amended at any time at the sole discretion of the Employer.
