Senior Validation and Compliance Lead

At Allucent , we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials and bring life-changing therapies to patients in need worldwide.

We are seeking a Senior Validation and Compliance Lead (India) to join our A-team (hybrid*). As a Senior Validation and Compliance Lead will be responsible for leading the Validation and Compliance activities within Technology Innovation assigned projects at Allucent. This position controls and monitors the Validation and Compliance status of GxP impacting systems, ensures planning, preparation, and execution of validation and testing activities in accordance with standard operating procedures, regulatory guidelines, executed client contracts, and clients expectations.

In this role your key tasks will include:

• Assist in developing and implementing a CSV strategy.
• Support the lifecycle of computerized system validation activities.
• Participate in risk assessments to help identify and mitigate compliance risks.
• Work with IT, QA, and functional teams to integrate validated systems into daily operations.
• Help maintain CSV documentation and assist in staff training.
• Stay informed about technological advancements and regulatory changes.
• Assist in audits related to computerized systems and support corrective actions.
• Contribute to continuous improvement by recommending process enhancements.
• Help assess IT controls and processes for alignment with policies and procedures.
• Support the development of the Risk Management Framework and Data Governance standards and processes.
• Guide teams to leverage data integrity controls to help ensure data is accurate, secure, consistent, and reliable throughout its lifecycle.
• Actively contribute to staff learning development within the Company.
• Provide and coordinate Validation Testers training for relevant staff.
• Review, improve, and evaluate processes and procedures within the Quality Management System.
• Ensure that all processes and systems meet quality standards and regulatory requirements.
• Support audit and inspection readiness by maintaining accurate and complete validation and compliance documentation.
• Actively participate in the resolution of audit/inspection findings and associated CAPAs.
• Assure strong long-lasting relationships with (future) key accounts.
• Support in the preparation of new proposals.
• Contribute and take part in client evaluations, visits and bid defences.