Experienced and results-driven Quality/Regulatory professional with an extensive 20-year tenure in GxP-focused organizations within the dynamic realm of the Global Business Environment. Adept at navigating complex regulatory landscapes and driving key strategic initiatives to fruition. Demonstrated proficiency in establishing and optimizing Quality Systems at both Country and Regional levels, ensuring compliance with stringent regulatory requirements while prioritizing Patient Safety and maintaining a steadfast Customer Focus Approach. Proven track record of achieving tangible outcomes and milestones, showcasing an unwavering commitment to excellence in quality management. Skilled in fostering cross-functional collaboration and implementing robust processes to streamline operations and enhance overall quality performance. Committed to driving continuous improvement initiatives and fostering a culture of compliance and excellence across all facets of the organization. Overall expertise lies in seamlessly integrating quality standards with business objectives, thereby bolstering organizational resilience and competitiveness in the global marketplace.
Regulatory Activities Undertaken
o Led the Abbott Manufacturing operations at Manesar-Gurgaon from year 2014 to Year April2018
o Strategic management of Quality/Regulatory function within healthcare organization.
o Identification, recruitment, and mentorship of talent, fostering professional development for goal achievement.
o Implementation of robust Quality Systems and processes to ensure compliance with regulatory standards.
o Oversight of manufacturing facility commissioning and qualification, adhering to cGMP requirements.
o Governance of supplier and distributor quality management protocols.
o Management of regulatory compliance activities including product registration and license management.
o Effective people management, with experience leading teams of up to 40 members.
o Development and execution of quality assurance strategies to enhance product safety and efficacy.
o Continuous improvement initiatives to streamline processes and optimize resource utilization.
o Collaboration with cross-functional teams to ensure alignment of quality objectives with business goals.
o Risk assessment and mitigation strategies to address potential quality issues.
o Conducting internal audits and assessments to maintain quality standards.
o Development and maintenance of regulatory documentation and submissions.
o Liaison with regulatory agencies to ensure adherence to evolving regulatory requirements.
o Implementation of performance metrics and KPIs to monitor quality performance.
o Development and execution of training programs to enhance quality awareness and compliance.
o Management of corrective and preventive action (CAPA) processes to address quality issues.
o Participation in regulatory inspections and ISO audits, ensuring readiness and compliance.
o Integration of quality management principles into business processes and decision-making.
o Evaluation and selection of quality management software and tools to enhance efficiency and effectiveness.
• Achieved “VP Excellence Award” for “Customer Intimacy Connect (A Continual Engagement)” in Year 2023.
• Achieved Abbott “Customer Centricity Award” for Outstanding Performance and Support to the business (SAARC) in Year 2022.
• Achieved “Award of Excellence” for the support given to commercial business on “Quality Challenges and NPI’s” - in Year 2022.
• Recognized and Won 2 “VP Excellence award” in Year 2021 (Project 1. India Legal Metrology Compliance Remediation, & Project 2. Launch of Navica/Panbio Covid-19 Antigen self-test in India).
• Reviewed/Approved documents for Product registration, submitted regulatory filings to India Regulatory Agency for product licensing and attained Test/Import Licenses for 8 Medical Devices (IVD) including COIVD-19 Detection Products in India, in year 2020.
• Established Quality framework for Abbott-Rapid Diagnostics Division for India Operations and completed QMS Integration project of Global Abbott Quality & Regulatory.
• Established enterprise QMS (Agile-PLM) at INDIA Operation site to manage QMS elements (Quality Incidents (QI), CAPA, Audits, SCAR’s, Field Safety Corrective Actions (FSCA), Documentation Management, Change Request (CR) & Change Orders (CO), Complaint Management System (SFDC).
• Commissioned New Manufacturing Facility for production of Diagnostics (IVD) products. Successfully delivered 15 Product for distribution in year2017 from New/Qualified Facility.