Senior Manager, Application Development

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.