Sridhar is an industry thought leader & strategic organizational transformation expert catalyzing “Quality as a competitive advantage” to enable larger business and patient outcomes. Passionate on Digitalization & leveraging technology and applying the principles of Industry 4.0 to Pharma 4.0.
A Progressive, Innovative and Performance oriented professional with proven leadership capabilities, keen customer centric orientation and entrepreneurial mindset; with over 26 years of Pharmaceutical Management experience using the learning from Quality & Operations Management across GxPs.
Develop and implement transformational strategies to ensure a culture of Quality, Compliance, Sustainability, Operational & Process Excellence using the principles of Risk Management, Change Management & Project Management. Implementing & leveraging digital technology and analytics for enhancing functional and business capabilities for faster, objective and risk-based decision making.
Expertise acquired through roles of increasing responsibility based in India & USA with span of responsibility across India, Asia Pacific, USA & EU regions; in a highly regulated environment for high volume/value, pharmaceutical products (OSDs, Sterile/ injectable, inhalation, APIs, biologics etc.), spanning Manufacturing, R&D, Commercial and Corporate functions etc. in varying business models.
He has successfully lead several regulatory inspections of USFDA, MHRA, MCC, TGA, ANVISA, EU countries and demonstrated continued compliance to CFRs, cGMPs, cGCPs, cGPvPs, CPSIA, SUPAC, ICH, EMEA guidelines, and practices, etc. Exposure to international markets such as the US, UK, EU, and other countries from a Quality & Compliance perspective. Demonstrated ability to build complete end – to – end Quality systems in support of “Ideation to Commercialization” for both internally and externally developed and manufactured products and; in/across manufacturing facilities serving diverse global markets, compliance across GxPs (GMP, GCP & GPvP) & leveraging and practicing.
In his current role, Sridhar is the Head Quality Operations for Stelis Biopharma leading a large team across multiple sites, for sterile fill finish& biological products. Previously, he has worked with several organizations such as Biocon,Novartis, Dr Reddy’s, Orchid & Cipla; as well as being an independent consultant.