Required qualifications to be successful in this role • Bachelor's degree in Life Sciences, Computer Science, Engineering, or related field. • Minimum of 8 years of experience in quality assurance and validation within the pharmaceutical industry. • Extensive experience working with Quality Management Systems (QMS) and tools such as Veeva or Trackwise. • Strong experience with validation processes and documentation, including IQ, OQ, PQ, and use of HP ALM for test management and traceability. • In-depth knowledge of GxP, 21 CFR Part 11, and other relevant pharmaceutical regulations. • Proven ability to lead and manage both offshore and onshore validation and QA teams. • Excellent project management skills with the ability to manage multiple projects simultaneously. • Strong problem-solving skills and the ability to mitigate risks effectively. • Excellent written and verbal communication skills, with the ability to collaborate across different functions and regions. • Experience managing external audits and ensuring regulatory compliance readiness