Job ID: JOB_ID_5055
Role Summary:
Seeking a senior-level consultant to lead and mature the Validation / CSV program, drive audit readiness for an upcoming FDA inspection, and oversee validation activities across key GxP SaaS platforms. This role requires a strong life sciences background, particularly in pharma and biotech, with extensive experience in GxP-regulated environments and SaaS-based GxP systems. The consultant will operate at a director level, assessing and remediating existing SOPs, policies, and validation frameworks, and developing a pragmatic remediation roadmap. A key focus will be on preparing the organization for an upcoming FDA audit and ensuring inspection readiness for SaaS-based GxP systems.
Key Responsibilities:
- Lead the company’s Validation / CSV program and operate at a director level.
- Assess existing SOPs, policies, and validation framework.
- Identify gaps and develop a pragmatic remediation roadmap.
- Define and implement a scalable, risk-based validation strategy.
- Drive rollout, adoption, and training on updated procedures.
- Prepare the organization for an upcoming FDA audit.
- Ensure inspection readiness for SaaS-based GxP systems.
- Review and strengthen validation documentation (plans, protocols, traceability, reports).
- Support audit readiness activities and potential audit interactions.
- Provide oversight to a team of 2 consultants executing CSV activities.
- Oversee validation across systems including: Veeva QMS & Veeva Training, Serialization systems, TMF (Trial Master File), and Argus (Pharmacovigilance).
Experience Required:
- Life sciences background (pharma, biotech).
- 12+ years in Validation / CSV within GxP-regulated environments with 5+ years of full-time manager experience.
- Strong knowledge of FDA regulations, GxP, and data integrity.
- Proven audit readiness and FDA inspection support experience.
- Hands-on validation experience with SaaS-based GxP systems.
- Experience assessing and remediating validation programs.
- Ability to operate strategically while remaining hands-on.
- Strong leadership, communication, and stakeholder management skills.
Nice to Have:
- Experience with risk-based validation / CSA approaches.
- Prior experience building validation programs from scratch.
Special Requirements
Audit readiness for FDA inspection, GxP SaaS platforms, FDA regulations, GxP, data integrity, inspection readiness for SaaS-based GxP systems, risk-based validation / CSA approaches.
Compensation & Location
Salary: $70 – $90 per year
Location: Waltham, MA
Recruiter / Company – Contact Information
Recruiter / Employer: Kappium
Email: a@kappium.com
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