Slipstream IT · 1 day ago
Director, Software Validation - Hampton, NJ
Hampton, NJ
Contract
Hybrid
Director/Executive
$90/hr - $100/hr
10+ years expSlipstream IT is a company that streamlines IT Support and provides managed solutions for emerging pharma and biotech organizations. The Director, Software Validation, is responsible for establishing and improving the company’s Computer System Validation program, ensuring compliance with regulatory requirements and overseeing validation activities for GxP-related computerized systems.
ConsultingInformation ServicesInformation Technology
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
Qualification
Required
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
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
Company
Slipstream IT
Slipstream IT provides IT outsourcing, managed services, and consulting services for emerging biotech and pharma companies.
201-500 employees
H1B Sponsorship
Slipstream IT has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2024 (7)
2023 (1)
2022 (1)
2021 (4)
Funding
Current Stage
Growth StageTotal Funding
unknown2025-08-05Private Equity
Leadership Team
Brandon McKay
Chief Executive Officer
Recent News
globallegalchronicle.com
2025-08-08
Company data provided by crunchbase