Job Description

About the Role

Join a specialized life sciences consulting firm managing complex M&A integrations and regulatory compliance projects. We're currently supporting a software company acquiring a CRO function, building GCP compliance frameworks for clinical operations across Phase III and IV trials.
We need an experienced CSV professional who can independently own validation projects from requirements through execution, working with cross-functional teams including engineering, QA, and business stakeholders.

Key Responsibilities

• Lead end-to-end validation of custom-built software systems
• Develop risk-based validation strategies aligned with CSA guidelines
• Create validation deliverables focused on requirements traceability
• Collaborate with software development teams during system implementation
• Ensure GxP compliance while maintaining project efficiency

Required Qualifications

Must-Have Experience

• Custom software validation experience (vendor-side or homegrown development teams)
• Proven ability to own complete validation projects independently
• Experience with 21 CFR Part 11, EU Annex 11, and GxP requirements
• Strong understanding of SDLC and modern validation approaches
• Ability to work effectively with engineering and business teams

Ideal Candidate Profile

• Highly self-directed and comfortable working autonomously
• Adaptable to changing project priorities and timelines
• Strong problem-solving skills in ambiguous situations
• Flexible with workload intensity (project work ebbs and flows)
• Confident interpreting regulatory requirements pragmatically

What We Offer

• Remote Work: Work from anywhere (US time zones)
• Challenging Projects: High-value M&A and integration work
• Autonomy: Lead your projects with minimal oversight
• Growth Potential: Two-year Project with expansion opportunities
• Support Network: Access to internal knowledge base and expert team

About Our Client

Our client is a boutique life sciences consulting firm with 30 years of experience specializing in complex regulatory compliance and M&A integration projects. They work with pharmaceutical and biotech companies on high-stakes initiatives where expertise and execution quality are paramount.

 

EOE

Thank you for your interest in iBoost Talent, we are proud to be an Equal Employment Opportunity Employer and participate in the E-Verify eligibility confirmation program.

Job Tags

Remote job, Temporary work, Flexible hours,

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