Job Type : Long-Term Contract

About the Role :

We are looking for an experienced CSV Lead with deep expertise in Computer System Validation, SAP S/4HANA upgrades, and strong Japanese language proficiency (JLTP N1).

This is a remote, long-term contractual role ideal for a proactive professional who can manage validation activities and compliance processes independently while collaborating in a global, cross-functional environment.

Key Responsibilities :

- Lead and manage CSV (Computer System Validation) activities across the project lifecycle, including concept, implementation, operations, and retirement phases.

- Work closely with teams involved in SAP S/4HANA upgrade initiatives.

- Review and approve validation deliverables to ensure compliance with regulatory guidelines and internal quality standards.

- Ensure adherence to GxP, GAMP5, 21 CFR Parts 11, 210, 211, 820, EU Annex 11, and GDP (ALCOA+).

- Collaborate with stakeholders in both Japanese (JLTP N1) and Business English for effective communication and documentation.

- Drive quality compliance activities including deviations, change controls, CAPA, and other QMS processes.

- Act as a key liaison between technical teams, QA, and regulatory stakeholders.

Required Skills & Qualifications :

- Minimum 10 years of hands-on experience in CSV, cloud validation, QA, and regulatory compliance.

- Proven track record with SAP S/4HANA implementations or upgrade projects.

- JLTP N1 certified with strong command of Business English.

- Deep understanding of pharmaceutical and life sciences regulatory frameworks.

- Proficiency in QMS tools and documentation standards for validation activities.

- Strong analytical, problem-solving, and communication skills.

- Ability to work independently in a remote, multicultural environment