Bhavilkumar Narola
Cluster Quality Leadership – Biotech | Driving Excellence in Quality & Compliance | Biologics | Sterile Injectables | Small Molecules
- Role
- Cluster Quality Head - Biotech at Wockhardt Ltd.
- Location
- Aurangabad, MH, IN
- LinkedIn followers
- 500 followers
About Bhavilkumar Narola
ENTERPRISE LEADERSHIP IMPACT & ACHIEVEMENTS1. Led enterprise and site Quality organizations supporting biologics APIs, sterile drug products, and CDMOoperations.2. Successfully supported and closed multiple global regulatory inspections, including USFDA, EMA,ANVISA, TGA, Health Canada, EAEU, NPRA, Ministry of Health Peru, and PIC/S authorities.3. Built, mentored, and governed large multidisciplinary teams of 200+ professionals across Quality Controland Quality Assurance functions.4. Designed and implemented robust Quality Management Systems (QMS), inspection remediationstrategies, and CAPA governance frameworks.5. Directed global analytical laboratories covering raw materials, in-process controls, finished products,stability programs, and validation testing.6. Led corporate technical training initiatives, strengthening GMP, analytical rigor, and inspection readinessacross manufacturing networks.7. Provided CDMO quality leadership, effectively aligning client expectations with regulatory andoperational execution.8. Authored six international peer-reviewed scientific publications in analytical and pharmaceuticalsciences.STRATEGIC QUALITY, COMPLIANCE & OPERATIONAL EXPERTISE- Global Regulatory Inspections & Compliance Strategy- Quality Operations – Biologics, Sterile Injectables & APIs- Analytical Laboratories & Method Lifecycle Management- Quality Management Systems (QMS) & CAPA Governance- Inspection Readiness, Risk Management & Remediation- People Leadership, Talent Development & Technical Training- CDMO Quality Oversight & Client Engagement- Business Continuity through Compliance-Driven Decision Making- Budgeting, productivity, and performance management
Experience
Cluster Quality Head - Biotech
Nov 2024 — Present · Aurangabad, IN
Providing enterprise level oversight of commercial Quality operations, regulatory compliance, inspectionreadiness, quality systems, and end-to-end product lifecycle management across multiple biotech API andbiologics sterile drug product manufacturing sites.
Education
Sardar Patel University, Vallabh Vidyanagar, Gujarat
Ph.D., Chemistry
2000 — 2004
Sardar Patel University
M.Sc, Analytical chemistry
1999 — 2000
Sardar Patel University
B.Sc, Chemistry
1995 — 1998
Find verified contacts for anyone on LinkedIn
Unifers gives sales teams verified emails and direct dials, enriched profiles, and outreach that lands in the inbox.
Free plan included · No credit card required
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.