Hyderabad, Telangana, India
Accomplished Chief Quality and Compliance Officer with over 28 years of international experience in APIs, PFIs, and FDFs including injectables, biologics, CTL, CROs, ADCs, Agrochemicals, SpecChem, Aligos and CRDMO. Experienced in managing Global Quality, Quality Operations, Global Operations, Third-Party/Contract Manufacturing, Regulatory Affairs, and audits & compliance. Has a strong record of ensuring regulatory adherence, operational optimisation, and business improvements. recognised for promoting a 'Quality as a Promise' culture worldwide, combining technical expertise with strategic leadership to ensure compliance and deliver high-performance results. Recognised for conducting over 600 global audits across all business verticals of the pharmaceutical industry in 15+ countries and successfully managed over 200 regulatory audits, including inspections by the US FDA, EDQM, PMDA, TFDA, KFDA, WHO-Geneva, Health Canada, INFARMED, COFEPRIS, TGA and ANSM, as well as numerous domestic and international customer audits Proven track record in leading cross-functional teams, ensuring cGMP compliance, driving QMS remediation activities, and integrating new business acquisitions to create synergies and enhance operational efficiency. Successfully integrated six newly acquired businesses, ensuring smooth transitions, maintaining business continuity, and fostering operational efficiency and synergy. I have a proven track record of driving success in both start-ups and established organizations by developing strategies for Quality Operations, leading cultural transformations, and achieving sustained compliance, growth, and profitability. With extensive experience in creating and implementing compliance and quality initiatives, I have consistently improved performance and enhanced organizational culture in both manufacturing and virtual companies. My expertise includes collaborating with global regulatory agencies and a comprehensive understanding of the entire pharmaceutical value chain, from drug development to distribution, encompassing Active Pharmaceutical Ingredients (APIs), Pharmaceutical Formulation Intermediates (PFIs), and Finished Dosage Forms (FDFs) including injectables, Biologics, Contract testing laboratories (CTL), Contract Research Organization (CRO), Antibody–Drug Conjugates (ADCs), Agrochemicals, Specialty Chemicals (SpecChem), and Organic Light Emitting Diode (OLED), Contract Research, Development, and Manufacturing Organization (CRDMO).
Responsible for the overall quality and RA, including QA, QC, CQA and DQA for the CRDMO, API, FDF, Specialty Chemicals, Biologics, CTL and CROs. Ensures the quality of products throughout the entire value stream, encompassing all steps from supplier quality to customer delivery. Ensures that all products and services are designed, developed, manufactured, packed, distributed, and marketed in compliance with regulations. Oversees and directs the quality management systems that ensure business, customer and regulatory requirements are met. Responsible for providing leadership, direction and coordinating quality function activities per the regulatory standards.
Responsible for the overall quality and RA, including QA, QC, CQA , DQA, and compliance for the CDMO, API, PFI, FDF, Specialty Chemicals, and CROs Integrated five newly acquired businesses, creating synergies and ensuring business continuity. Ensures the quality of products throughout the entire value stream, encompassing all steps from supplier quality to customer delivery. Ensures that all products and services of Suven and Cohance are designed, developed, manufactured, packed, distributed, and marketed in compliance with regulations. Oversees and directs the quality systems that ensure business, customer, and regulatory requirements are met. Responsible for providing leadership, direction, and coordinating quality function activities per cGMP.
Responsible for Quality Operations (QA, QC, CQA, DQA), Regulatory Affairs, Audit & Compliance for the CDMO, API, PFI, FDF, Specialty Chemicals, and CROs. Integrated three newly acquired businesses, creating synergies and assuring business continuity. Ensures quality of products through the entire value stream; all steps from supplier quality to customer delivery. Ensure that all products and services of Cohance are designed, developed, manufactured, packed, distributed, and marketed in compliance with regulations. Oversee and direct the quality systems that ensure business, customer, and regulatory requirements. Responsible to provide leadership, direction, and coordinating quality function activities by the cGMP.
Responsible for Quality Compliance and Regulatory Affairs for the API, Formulations, and CRBio. Oversee and direct the quality systems that ensure business, customer, and regulatory requirements. Responsible for providing leadership, direction, and coordinating quality function activities by the cGMP.
Responsible for the overall quality, including QA, QC, CQA, DQA, compliance, and regulatory affairs for the CDMO, API, PFI, FDF, Specialty Chemicals, and CROs. Integrated five newly acquired businesses, creating synergies and ensuring business continuity. Ensures the quality of products throughout the entire value stream, encompassing all steps from supplier quality to customer delivery. Ensures that all products and services of Suven and Cohance are designed, developed, manufactured, packed, distributed, and marketed in compliance with regulations. Oversees and directs the quality systems that ensure business, customer, and regulatory requirements are met. Responsible for providing leadership, direction, and coordinating quality function activities per cGMP.
Oversee and direct the quality systems that ensure business, customer and regulatory requirements. Responsible to provide leadership, direction and coordinate quality function activities in accordance with the cGMP.
Oversee and direct the quality systems that ensure business, customer, and regulatory requirements. Responsible to provide leadership, direction, and coordinating quality function activities by the cGMP. Responsibility includes Quality, Audit & Compliance, and Vendor management