100% remote - Nearshore - Senior GXP Consultant (m/f/d)

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Duration: 6 months+ | Start: 11/2026 | Remote: 100%

Beschreibung

IT
Software as a Service
Software Quality
Gmp-compliant Documentation
GXP
Description
We are looking for a Senior GxP Consultant to support the GxP readiness, validation and compliant
operation of a SaaS application used in regulated pharmaceutical environments. The role combines
strong pharmaceutical domain expertise with hands-on experience in GAMP 5-based software
development, computerized system validation and the operation of SaaS solutions throughout their
lifecycle.
Timeline: 23.11.2026 - 31.05.2027 (Possible prolongation)
Full-Time
Location: 100% remote
Key Responsibilities
• Advise product-, development-, operations- and quality-teams on GxP-compliant software
development and SaaS operations.
• Define, review and continuously improve the GxP validation and qualification approach across
the software and service lifecycle.
• Ensure alignment of agile software development and release processes with GAMP 5
principles and applicable pharmaceutical quality requirements.
• Support requirements management, risk assessments, traceability, validation planning, test
strategies, test evidence, validation reporting and
release readiness.
• Establish and review GxP-relevant processes, SOPs, work instructions, quality gates, roles
and responsibilities.
• Assess data integrity, change control, configuration management, segregation of duties and
documented evidence within development and operations
processes.
• Support validation and qualification activities for SaaS applications, underlying platforms and
customer-specific implementations.
• Prepare for and support customer audits, internal audits and regulatory inspections, including
remediation of identified gaps.
• Act as the interface between pharmaceutical Quality/Validation stakeholders and software
engineering, DevOps and operations teams.
• Coach technical and operational teams on practical GxP implementation and documentation
expectations.
Required Experience and Skills
• Extensive professional experience in GxP-regulated pharmaceutical or biotechnology
environments, ideally gained directly within the pharmaceutical
industry.
• Strong practical knowledge of GAMP 5 and computerized system/software validation,
including risk-based validation approaches.
• Demonstrated experience with validation of software applications, preferably including
custom-developed or configured solutions.
• Solid understanding of the Software Development Life Cycle (SDLC), including requirements,
design, development, testing, release, change management and operation in a regulated
environment.
• Experience with SaaS/cloud application lifecycle management and the corresponding division
of responsibilities between provider and regulated customer.
• Strong knowledge of GxP documentation and validation deliverables such as validation plans,
risk assessments, requirements/specifications,traceability matrices, test plans/reports and
validation or qualification summary reports.
• Good understanding of pharmaceutical quality systems, data integrity principles and
audit/inspection expectations.
• Ability to translate regulatory and quality requirements into pragmatic, implementable controls
for development and operations teams.
• Excellent stakeholder management and communication skills, with the ability to work across
Quality, IT, Engineering, Operations and customer
organizations.
• Min. 8 years work experience in a Pharma company
• Min. 8 years experience in SW development environment in a Pharma company (NO
supplier/explicitly Pharma company)
• Fluent English, both written and spoken.
Preferred Qualifications
• Previous responsibility for pharmaceutical software validation or computerized system
validation (CSV/CSA).
• Experience with GAMP Category 4 and/or Category 5 software and associated validation
approaches.
• Familiarity with EU GMP Annex 11 and FDA 21 CFR Part 11 requirements.
• Experience with agile software development and DevOps in a regulated environment,
including documented testing and release evidence.
• Experience with cloud platforms, SaaS operations and regulated IT service management.
• Experience supporting pharmaceutical customer audits and regulatory inspections.
• Background combining pharmaceutical industry experience with software development,
software quality or validation expertise.
Ideal Candidate Profile
The ideal candidate is an expert GxP professional who understands both the pharmaceutical
quality perspective and the realities of modern SaaS software engineering and operations. They
can independently assess an existing development and operating model, identify compliance
gaps, define pragmatic remediation measures and guide teams toward a sustainable, audit-ready
GxP operating model