Join our dynamic Cyber Team as an Assistant Manager, where you'll be instrumental in fortifying organizations against cyber threats. We focus on building secure, vigilant, and resilient systems, enabling clients to navigate the evolving digital landscape and seize new opportunities. Your role will involve cultivating strong client relationships and exceeding expectations through effective risk management strategies.

As a key member of our Cyber strategy practice, you will contribute to embedding cyber risk management into the core of client strategies, ensuring the effective governance of information and technology assets.

In this role, you will validate software applications and computer systems, conducting GxP analysis, gap assessments, and ERES assessments. You will be involved in the Software Development Life Cycle (SDLC) and Software Testing Life Cycle (STLC), applying various testing methodologies and focusing on software quality assurance and risk management.

Your responsibilities will include reviewing GAMP guidelines, ensuring project compliance with client SDLC methodologies, and reporting compliance status to global leadership. You'll also ensure the applicability of Computer System Validations (CSV) within complex regulatory frameworks and coordinate incident management for validated systems.

We are seeking professionals with experience in regulatory compliance, including knowledge of 21 CFR Part 11 and EU Annexure 11, particularly within FDA-regulated environments with a strong understanding of cGxP.

Proven experience in performing GxP relevance assessments and ERES assessments is essential. You should be adept at coordinating incident management, evaluating system changes through change control procedures, and supporting system administration and maintenance to uphold validated states. A background in quality systems such as CMMi or ISO, along with a track record in validation and qualification of complex computer systems, is highly valued.