Senior Manager, CSV IT
Job Description
Key Responsibilities:
1. CSV Strategy & Governance
- Develop and maintain the overall CSV strategy and validation master plans for global systems.
- Ensure compliance with GAMP 5, USFDA, EU Annex 11, 21 CFR Part 11, and global regulatory requirements.
- Establish standardized validation methodologies, templates, SOPs, and best practices.
2. Project & Stakeholder Management
- Lead validation planning and execution for enterprise applications including ERP, LIMS, DMS, QMS, LMS, and others.
- Collaborate with functional teams, QA, and global stakeholders.
- Work with vendors/partners to align on validation scope and deliverables.
3. Validation Execution
- Oversee and review CSV documentation: URS, FS, DS, Risk Assessments, IQ/OQ/PQ, Validation Reports, Periodic Reviews.
- Ensure traceability and compliance across lifecycle deliverables.
- Monitor deviations, CAPAs, and change controls.
4. Audit & Compliance Leadership
- Act as the face of IT CSV during internal, external, and regulatory audits (USFDA, MHRA, etc.).
- Provide expert guidance on compliance gaps and remediation.
- Track industry trends and regulatory updates.
5. Team Leadership
- Lead and mentor a team of 4–5 CSV professionals.
- Review deliverables and ensure timely completion of activities.
- Drive capability building and continuous improvement.
Preferred Attributes:
- Certifications in CSV, GAMP, or related domains.
- Experience with cloud/SaaS validation.
- Experience in global cross-functional environments.
Required Skills & Qualifications:
- 12–15 years of pharmaceutical industry experience in GxP environments.
- Strong CSV experience with ERP, LIMS, QMS, LMS, DMS systems.
- Deep knowledge of GAMP 5, 21 CFR Part 11, Annex 11, data integrity principles.
- Strong documentation, communication, and stakeholder-management skills.
- Experience representing IT in regulatory audits.