With over 30 years of experience in the regulated pharmaceuticals industry and FMCG company. A skilled and responsive Senior Quality & Audit Director, able to manage interfaces with senior stakeholders, including heads of departments and cluster leads through multi-faceted audit processes. My key expertise include• Expertise in managing strategic & operational performance of Quality Department involving development & implementation of standardized quality systems in API, R&D sites and manufacturing of various dosage forms such as Solid & Liquid Orals, Topical, Nutraceuticals, Food, Sterile, and Aerosols as well as commercial quality.• Extensive experience in ensuring quality & compliance, managing risk, internal & external audit, facilitating technology transfer in Pharmaceutical & Consumer Durables industries.• Ensuring an effective governance structure to ensure oversight of quality activities is maintained and providing expertise for GMP & GDP activities for internal sites, suppliers and CMOs. Successfully delivered GMP/GDP quality strategies.• Proficient in leading global projects through excellent communication and organization skills with ability to make decisions, conducting audits, implementing quality management systems, with a strong focus on capability building, data integrity, and quality compliance.• Bridging of the technical requirements within Quality and balancing this with industry standards to achieve business goals.• Excellent track record of assuring that all products produced represent the maximum quality and reliability attainable by establishing effective quality compliance inspections, tests and corrective procedures.• Sound understanding of standards & systems of USFDA, MHRA, EUGMP and strong exposure of participating in external audits of respective regulatory authorities and performing review of ANDA filings & deficiency response to FDA.• Often autonomous and able to lead multi departmental and global projects.• Visited various countries such as UK, USA, Japan, Germany, Singapore, UAE, Saudi Arabia, Egypt, Vietnam, Indonesia, and Sri Lanka..