Senior Audit Manager

12 hours ago

Hyderabad, Telangana, India beBeeAudit Full time ₹ 1,50,00,000 - ₹ 2,50,00,000

Job Overview

We are seeking a highly skilled and experienced audit professional to join our team as a Senior Audit Manager. The ideal candidate will have a proven track record of managing audits and regulatory inspections, with expertise in GxP processes and compliance requirements.

Key Responsibilities
  • Govern the entire audit process, ensuring effective coordination and management of audits and inspections involving Data, Digital & IT systems and processes.
  • Support GxP audits (e.g., GMP, GCP) and regulatory inspections by authorities such as FDA, EMA, MHRA, and Swissmedic.
  • Act as a liaison to ensure relevant DD&IT subject matter experts address audit queries and deliver required documentation in a timely and accurate manner.
Required Skills and Qualifications
  1. University degree or equivalent. Masters degree in IT, Quality Management, Business Administration, or related fields.
  2. Overall 8-10 years of work experience in quality management, audit, and compliance within IT, preferably in a global organization.
  3. Experience in the pharmaceutical industry or other regulated industries, with knowledge of GxP processes and compliance requirements.
  4. In-depth understanding of pharma business processes and their interrelationship with IT systems and regulatory frameworks.
  5. Proven track record of managing audits, regulatory inspections, and remediation efforts in pharma or other highly regulated environments.
  6. Experience with Computer System Validation (CSV), system testing, and adherence to lifecycle validation processes (e.g., requirements gathering, system design, validation testing, implementation, and maintenance).
  7. Knowledge of ITIL processes and best practices.
  8. Demonstrated ability to work effectively in large, cross-functional, global organizations.
  9. Proficient in Excel, PowerPoint, and other productivity tools for reporting and presentation.
  10. Business-proficient in English (written and spoken).
  11. Strong communication skills with the ability to articulate expectations and audit requirements clearly to diverse teams and stakeholders.
  12. Ability to manage multiple priorities and time-sensitive processes efficiently.
  13. ITIL-certified professional.
  14. Strong knowledge of validation practices, including GxP, Sarbanes-Oxley (SOX), and pharmaceutical quality compliance standards.
  15. Understanding of CSV lifecycle processes, including risk assessment, traceability matrix development, protocol execution, and impact analysis.
  16. Business knowledge or experience in IT's role supporting audit and compliance functions within regulated industries.
  17. Expertise in Computer System Validation (CSV) testing methodologies and frameworks.

As a Senior Audit Manager, you will have the opportunity to work with a dynamic team and contribute to the success of our organization. If you are a motivated and detail-oriented individual with a passion for audit and compliance, we encourage you to apply for this exciting opportunity.

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