Akkineni Sekhar
Cqa - Vice Presidnet and Cqa Lead @Lupin
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WORK HISTORY
Cqa - Vice Presidnet and Cqa Lead @Lupin
Mumbai, IN
Executive SummaryVisionary pharmaceutical leader with 35+ years of international experience, excelling in operational excellence,regulatory compliance, and business growth across India, the Middle East, and global markets. Proven expertise insteering large-scale organizations, building high-performance teams, and driving sustainable value throughinnovation, strategic partnerships, and robust governance. Skilled in navigating complex regulatory frameworks(USFDA, EMA, WHO, PMDA), leading digital transformation, and executing market expansion strategies. Recognizedfor industry-first product launches, crisis management, and championing patient-centric initiatives.Leadership Highlights• Directed multi-site operations and corporate quality for leading pharmaceutical companies, ensuring globalregulatory compliance and inspection readiness.• Orchestrated successful product launches and market entries in the US, EU, Japan, and emerging markets.• Led enterprise-wide digital and process transformation, including data restoration post-cyberattack andadvanced QMS/SOP implementation.• Built and mentored cross-functional teams, fostering innovation and continuous improvement.• Forged strategic alliances and managed high-stakes stakeholder relationships to drive growth and resilience.
EDUCATION
Birla Institute of Technology and Science, Pilani
Master of Science - MS
SKILLS
ABOUT AKKINENI SEKHAR
A Pharma professional with extensive experience in the areas of domestic and international regulations, has over 30 years’ experience in Pharma Industry and is well versed in manufacturing and quality systems. Held senior management positions in QA, Manufacturing, QC and Regulatory AffairsWorked in the Pharmaceutical industry to develop quality assurance and regulatory strategies for compliance with stringent regulatory authorities such as US FDA, MHRA, EMA, PMDA and others Experience includes support for process development, technology transfer, assisting with remediation activities, especially on CAPAs, root cause analysis. Conducted GMP assessment of facilities and support to help companies address quality systems deficiencies.
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