Sridhar Balasubramanian

About Sridhar Balasubramanian

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 25 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 makingDemonstrated 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.Successfully lead over 25 regulatory inspections of USFDA, MHRA, MCC, TGA, ANVISA, EU countries and demonstrated continued compliance across all GxP areas and CFRs, cGMPs, cGCPs, cGPvPs, CPSIA, SUPAC, ICH, EMEA guidelines and practices etc. Develop cross functional teams to achieve sustained growth in both functional and business outcomes by instilling a higher level of commitment, collaboration and communication. Rich experience in developing high performing small / large teams across functions / cultures/ geographies as well as multiple manufacturing sites. 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.Direct exposure to international markets such as US, UK, EU, Russia and other countries from a Quality & Compliance perspective; inclusive of external of interfacing with clients and partners.

Experience

1. Head - Quality Parenteral

   Dr. Reddy's Laboratories

   Jun 2025 — Present · Hyderabad, IN

Education

• Symbiosis Institute of Management Studies

  Master's Diploma in Business Administration

  2006

• American Society for Quality

  Certified Quality Auditor

  2012

• Manonmaniam Sundaranar University

  MS, Microbiolgy

  1993 — 1995

• University of Madras

  BS, Zoology

  1990 — 1993

• Assembly of God Church

  ISC

  1988 — 1990

• American Society for Quality

  Certified Manager for Quality/ Organizational Excellance, 2012

• American Society of Quality

  Pharmaceutical GMP Professional Certification

  2012

• St Andrews high School

  SSC

  1981 — 1988

• RABQSA International

  Lean 6 Sigma Green Belt Certification

  2012

Skills

• Microbiology
• Business Acume & Decision Making
• Change Management
• Gmp
• Risk Management
• Team Management
• Fda
• Performance Orientation
• Learning & Coaching
• Quality Systems
• Regulatory Compliance
• Quality by Design
• Building & Leveraging Relationships
• Anda
• Formulation
• Knowledge Management
• Continuous Improvement
• Compliance
• Supplier Management
• Cgmp
• Quality Auditing
• Communicating & Influencing
• Innovation
• Problem Solving
• Alliance Development
• Validations
• Product Life Cycle Management
• Pharmaceuticals
• Cglp