Validation Manager – Holistic Data Management, Pharma

🔥 0 minutes ago

🇪🇸 Spain – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

👔 Manager

👻 Ghost score 10%

What it means: the chance that no one is really hiring for this job.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

Apply Now

Find Similar Remote Jobs

Ambit Iberia

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 2003

💼 Consulting

🏥 Healthcare

Consulting • Healthcare

Ambit Iberia is a company specialized in providing digital solutions and regulatory and quality consulting services for the Life Sciences sector. The company offers a range of services including consulting in regulatory affairs, IT quality consulting, and the implementation of various ISO standards. With a strong focus on information technology, Ambit Iberia leverages its knowledge and experience to meet client needs in the rapidly evolving IT landscape.

📋 Description

• Own and coordinate all validation activities for the system • Prepare, review, and maintain validation documentation, including Validation Plans, Test Documentation, Traceability Matrices, Validation Summary Reports, and related records • Lead qualification activities across QA and Production environments, ensuring release readiness • Coordinate validation testing activities, deviation management, and defect resolution • Ensure compliance with CSV, GxP, GLP, and applicable validation standards • Review and support SOPs, AAPs, training materials, and operational documentation required for go-live • Collaborate with Business stakeholders, IT System Leads, Quality Assurance, CSV & Compliance teams, and System Owners to support validation approvals and compliance-related activities • Act as a key compliance partner during audits, inspections, and system lifecycle activities • Lead validation for a global pharmaceutical data management initiative from testing to go-live

🎯 Requirements

• Bachelor's degree in Information Technology, Healthcare, Life Sciences, or a related field • Strong knowledge of Computer System Validation (CSV) principles and methodologies • Expert understanding of FDA 21 CFR Part 11 • Expert understanding of EU GMP Annex 11 • Expert understanding of GxP requirements and validation best practices • Experience preparing and maintaining validation documentation in regulated environments • Solid understanding of validated IT systems, including software, infrastructure, and system integrations • Strong analytical, documentation, and stakeholder management skills • More than 3 years of experience in Computer System Validation within the pharmaceutical, biotechnology, or life sciences industry • Experience supporting complex data management, digital transformation, or enterprise applications • Previous exposure to audit and inspection readiness activities • Experience working within global, cross-functional teams • Monday–Friday availability during 08h–17h schedule, with flexibility

🏖️ Benefits

• Permanent contract • Flexible compensation plan (free of income tax) including medical insurance, public transport ticket, and childcare check • Discounts in gym network • Training catalogue • Referral program • Flexible working hours • Fully remote work

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume