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Protocol Intelligence
Data-driven signals on your job's competitivenessTier-1 employer and metro location raise competition, but niche regulated CSV expertise limits applicant pool.
Requires regulated medical-device CSV and GxP expertise, limiting transferability across industries.
Explicit 8-12 years, mandated CSV/regulatory expertise, and audit readiness create stringent screening.
Job Description
Structured overview of role & requirementsAbout This Role
Lead and execute risk-based assurance and validation (CSV/CSA) for computerized systems supporting medical device quality and business processes.
Own and strengthen the validation framework ensuring systems are compliant, inspection-ready, and maintained in a validated state across their lifecycle.
Support audits and inspections, manage quality issues, drive validation process improvements, and mentor validation teams and stakeholders.
Minimum Requirements
8-12+ years experience in computerized systems validation or quality assurance in regulated life sciences sectors (medical devices, pharma, biotech, diagnostics).
Bachelor's or Master's degree in engineering, computer science, information systems, life sciences, quality, or related technical field, or equivalent experience.
Hands-on experience authoring, executing, reviewing, and approving CSV/CSA deliverables for complex computerized systems.
Work Model: Office-based / Hybrid (designation to be confirmed).
Ideal Candidate Profile
Experienced at applying risk-based validation and assurance aligned with GxP regulations and FDA/EU standards (21 CFR Part 11, Annex 11, ISO 13485).
Proficient in collaborating with cross-functional teams (IT, Regulatory, Cybersecurity, suppliers) in a matrix environment to influence quality decisions.
Background in managing lifecycle controls for enterprise platforms (ERP, QMS, cloud/SaaS) and interfacing with audits and regulatory inspections.