NEWPosted 5 hours ago

Job ID: JOB_ID_5404

Job Description:

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.

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), 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

USC & GC Only; Onsite work arrangement; Direct logo experience required

Compensation & Location

Salary: $75 – $95 per year (Estimated)

Location: Waltham, MA

Recruiter / Company – Contact Information

Email: a@kappium.com

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