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Tier-1 pharmaceutical brand and metro location increase competition despite niche compliance specialization.
Highly industry-specific GxP and regulatory compliance skills limit cross-industry transferability.
Mandatory 8–13 years and GxP/computer system validation expertise make filters stringent.
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Support and manage technology compliance and validation activities for GxP computerized systems at Amgen Breda site, ensuring systems remain in a validated state of operation.
Coordinate and track compliance lifecycle tasks including periodic reviews, data integrity assessments, inspection-readiness, and documentation management.
Collaborate with cross-functional teams (Quality, Validation, System Owners) to enforce consistent technology compliance processes and handle compliance events and deviations.
8–13 years of relevant experience in Life Sciences, Biotechnology, Pharmacology, Information Systems, Computer System Validation, Quality, or Technology Compliance.
Strong knowledge of GxP computer system compliance including 21 CFR Part 11, EU Annex 11, and data integrity requirements.
Experience with risk-based approaches to computer system validation and lifecycle management.
Willingness and ability to work evening or night shifts as required.
Experienced in managing GxP technology compliance operations within a regulated pharmaceutical or biotechnology manufacturing environment.
Effective at cross-functional collaboration with quality, validation, and technology teams, ensuring regulatory alignment and audit readiness.
Skilled in detailed documentation, compliance tracking, and presenting compliance status and gap assessments clearly to stakeholders.