Back
Mid-level experience requirement and known pharma brand increase applicant density balanced by niche regulated-skill requirements.
Role requires specialized bio-pharma validation and regulatory experience, limiting cross-industry transferability.
Explicit 3-5 years plus mandatory GxP/CSV/GAMP regulatory skills and audit readiness make filters stringent.
Login to See Your Match Score
Create a free account or log in to unlock your CV match score across:
Coordinate and support quality, validation, and IT security control activities across assigned bio-pharma IT projects ensuring compliance with GAMP5, CSV SOPs, SDZ standards, IMF, and regulatory requirements.
Manage execution of risk-based reviews, validation checks, security control verifications, and documentation related to quality and validation to maintain audit readiness.
Collaborate with project managers and stakeholders to deliver quality and compliance outcomes, track escalations, and support continuous improvement initiatives with fit-for-purpose, lean approaches.
3-5 years of relevant experience in BioPharma IT Quality & Compliance departments with hands-on quality management in multiple international or cross-functional IT projects.
Bachelor's Degree or equivalent in Computer Science, Information Systems Management, Mathematics, Informatics, or related field.
Expert knowledge and hands-on experience in Quality and Security Management including GxP, CSV, and GAMP compliance.
Strong understanding of pharmaceutical validation requirements driven by health authorities (e.g., FDA).
Experienced in managing quality within regulated bio-pharma IT project environments, capable of applying GAMP5 and pharma validation standards effectively.
Proficient in agile methodologies and IT system lifecycle processes, with a balance of quality assurance and information security expertise.
Able to communicate complex quality and compliance information clearly to technical and non-technical stakeholders and drive risk mitigation collaboratively.