ANUP KUMAR RAI
Ahmedabad
Summary
Strategic and results-driven pharmaceutical quality leader with over 17 years of experience across biologics, biopharmaceuticals, pharmaceuticals, and medical devices. Proven expertise in global Quality Management Systems (QMS), regulatory compliance, digital transformation, and operational excellence. Adept at leading cross-functional teams, managing multi-site operations, and driving enterprise-wide initiatives that align quality with business strategy. Recognized for advancing quality culture through technology, innovation, and regulatory alignment.
Overview
17
17
years of professional experience
1
1
Certification
Work History
Global QMS and Digitization Head
Enzene Bioscience Ltd.
10.2024 - Current
- Quality Management Oversight: Strategically developed and sustained robust QMS frameworks aligned with global regulatory standards (USFDA, EMA, TGA, WHO) across Enzene’s India and U.S. operations. Oversaw compliance functions, including deviation management, CAPA, change control, market complaints, OOS/OOT, product recalls, and routine quality operations. Led regulatory inspection readiness and partner audit compliance while optimizing QMS processes at both the corporate and site levels.
- Digital Transformation Leadership: Spearheaded enterprise-wide digital initiatives across QMS, LMS, Document Management, and validation protocols. Deployed platforms such as MasterControl, Caliber LIMS, SAP, e-Logbook, and e-BMR to enhance operational efficiency, data integrity, and regulatory transparency.
- Quality Control Excellence: Directed QC operations across multiple sites, aligning corporate QC policies and procedures with international regulatory requirements. Established and monitored QC KPIs to drive consistency, performance, and continuous improvement.
- Regulatory Compliance & Audit Readiness: Orchestrated strategic preparedness for global inspections, partner audits, and customer engagements. Led the resolution of audit observations through root cause analysis and CAPA execution. Delivered digital solutions to streamline audit management and regulatory submissions.
- Strategic Leadership: Provided executive direction for quality and digitization initiatives, aligning QA/QC strategies with business goals, and regulatory requirements. Served as a senior leadership team member, advising on quality risks, industry trends, and innovation opportunities.
- Risk Management: Implemented robust risk management frameworks to identify, assess, and mitigate quality risks. Led investigations and ensured the timely resolution of quality issues, including pharmacovigilance and product recall procedures.
- Collaboration and Stakeholder Engagement: Partnered with R&D, manufacturing, supply chain, and regulatory teams to embed quality into all deliverables. Engaged with external suppliers, CMOs, and industry forums to uphold compliance, and represent Enzene in regulatory discussions.
- Team Development & Management: Recruited, trained, and mentored QA/QC personnel, building a high-performing team culture rooted in accountability, collaboration, and innovation.
- Budget Management: Allocated resources strategically across QA/QC, and distribution functions. Implemented cost control measures for raw materials, equipment, and personnel, ensuring budget adherence and operational efficiency.
Senior Manager (Worked as Quality and Digitization Lead)
Biocon Biologics Ltd.
01.2020 - 10.2024
- Managed core Quality Management System (QMS) activities, including deviation management and change control.
- Oversaw Annual Product Quality Reviews (APQRs), ensuring regulatory compliance through process validation and document management.
- Implemented advanced solutions like TrackWise and LIMS, driving digital transformation for operational excellence.
- Spearheaded successful USFDA and EMA inspections for Malaysia site, achieving consecutive clearances from 2020 to 2024.
- Developed quality indicators while addressing challenges, enhancing adherence to corporate metrics across operations.
- Delivered GMP training programs to strengthen compliance culture among subject matter experts (SMEs).
- Led cross-functional meetings to report project updates and resolve operational challenges efficiently.
- Recognized by Biocon's Senior Leadership team with awards for contributions to quality excellence and continuous improvement initiatives.
Manager, Corporate Quality Assurance & Digitization
Macleods Pharmaceutical Ltd.
08.2018 - 11.2019
- Managed corporate quality assurance functions, ensuring the seamless execution of quality policies and procedures across more than ten manufacturing sites, including API, Formulation, and loan license facilities.
- Ensured compliance with Quality Management Systems (QMS) across Macleods and Contract Manufacturing sites, maintaining global regulatory alignment.
- Led quality improvement, digitization (TrackWise, LIMS, LMS), and remediation projects, collaborating with cross-functional teams, vendors, and consultants for successful implementation.
- Oversaw regulatory commitments, ensuring timely review, submission, and closure of CAPAs while coordinating monthly Quality Review Meetings (QRM) to sustain key performance metrics.
- Spearheaded corporate initiatives in Computer System Validation (CSV) and Data Integrity compliance across manufacturing sites.
- Managed corporate-level QMS activities, including product recalls, supplier qualification, vendor management, and internal audits.
- Collaborated with business development, marketing, and supply chain teams, as well as contract manufacturers, to finalize technical agreements aligned with organizational objectives.
- Directed corporate audit programs, conducting inspections at manufacturing sites, ensuring compliance from auditee sections, and leading supplier audits with action tracking for closure.
- Partnered with R&D, Bio-equivalency, Analytical Development, and Process Development laboratories to drive new product development and lifecycle management.
- Achieved successful audit clearances for USFDA, MHRA, TGA, and WHO inspections across multiple manufacturing sites, ensuring sustained regulatory compliance and operational excellence.
- Executed digital transformation initiatives, deploying TrackWise for Quality Management Systems (QMS), Caliber LIMS for Quality Control, and electronic Learning Management solutions to enhance operational efficiency, compliance, and data integrity across the organization.
Manager, Quality Assurance
Pfizer Healthcare Ltd.
06.2016 - 07.2018
- Led the execution of global, site, and compliance remediation projects, as well as site integration initiatives across three API manufacturing sites.
- Oversaw coordination among site execution teams, technical owners, network SMEs, stakeholders, and consultants to ensure smooth project delivery.
- Provided weekly progress updates to Pfizer senior leadership in key meetings and forums.
- Monitored quality key performance indicators (KPIs) and metrics, collaborating with cross-functional teams to meet site, network, and Pfizer global targets.
- Managed regulatory commitments, vendor/supplier compliance, and timely closure of CAPA actions.
- Ensured continuous audit and inspection readiness for manufacturing facilities, leading site SME development programs in collaboration with global SMEs.
- Served as Data Integrity Lead, driving data integrity initiatives and Computer System Validation (CSV) projects.
- Ensured compliance with ALCOA, GAMP-5, and 21 CFR Part 11, implementing system controls to maintain regulatory integrity.
- Spearheaded Quality Control improvement projects, including 5S implementation, Good Laboratory Practice (GLP) enhancements, testing reduction strategies, and document simplification to optimize efficiency and compliance.
- Successfully led PMO efforts for USFDA, WHO, and MHRA inspections, ensuring seamless regulatory compliance and audit readiness.
- Spearheaded the implementation of QMS digital solutions, including TrackWise, LMS, Document Management, and EAMS, enhancing efficiency and compliance.
- Delivered key global integration and improvement initiatives, including Quality Policy standardization, investigation management, Internal Audit Program enhancements, Supplier Qualification, Inspection Readiness, and Data Integrity initiatives.
- Led transformational projects such as the 5S program for Quality Control, Microbiology laboratory enhancements, and the implementation of aseptic manufacturing standards.
- Honored with Pfizer’s prestigious 'Own It' and 'Quality Excellence Award' in recognition of leadership and contributions to quality and compliance excellence.
Manager, Corporate Quality Assurance
Abbott Healthcare Ltd.
12.2015 - 05.2016
- Managed comprehensive Quality Management Systems (QMS) oversight for Abbott manufacturing sites, Third Party Manufacturing (TPM) facilities, and Loan Licensing Parties (LLP), ensuring regulatory alignment and operational excellence.
- Led corporate-level QMS functions, including Event/Investigation management, Product Recall/Withdrawal, FAR, CAPA, Change Control, and Internal Audit/Self-Inspection processes.
- Provided technical guidance to site teams for seamless execution of quality operations.
- Ensured strict adherence to Good Distribution Practices (GDP) for pharmaceutical products and medical devices, maintaining compliance with industry standards and regulatory requirements.
- Collaborated closely with R&D, supply chain, marketing, and site teams to drive new product launches and lifecycle management, ensuring smooth transitions from development to commercialization.
- Oversaw vendor and supplier qualification processes, ensuring compliance, risk mitigation, and overall management to uphold quality standards.
- Led the audit program, conducting internal and external assessments for TPM and loan licensing partners, ensuring ongoing regulatory compliance across Abbott manufacturing sites.
- Led the successful implementation of the TrackWise digitization project for Quality Management Systems (QMS), Vendor Management, and Audit Management across Abbott's Corporate Office and internal sites.
Assistant Manager, Quality Assurance
GlaxoSmithKline Pvt. Ltd.
11.2014 - 12.2015
- Led site-wide remediation initiatives for Quality Management Systems (QMS), driving compliance through the effective implementation of corrective and preventive measures.
- Managed Deviation, CAPA, Market Complaints, Change Management, Internal Audits, Supplier Audits, Product Recalls, Regulatory Inspections, and Quality Operations to maintain regulatory excellence.
- Served as QMS Champion and Audit Process Manager, ensuring the successful implementation of GSK policies and procedures at the site.
- Conducted self-inspections, internal audits, and external audits as scheduled, tracking compliance actions through structured follow-ups.
- Acted as the primary liaison for regulatory authorities and external auditors, facilitating seamless inspections and compliance adherence.
- Monitored Key Performance Indicators (KPIs) and led multiple Quality Improvement Projects & Programs, driving impactful changes across site operations.
- Championed Lean Manufacturing, 5S, and Kaizen projects as part of continuous improvement efforts, ensuring product compliance with ISO, WHO, and FDA standards.
- Developed and executed remediation plans to address regulatory and audit findings, collaborating with cross-functional teams to implement CAPA initiatives.
- Conducted root cause analysis to resolve quality issues and establish preventive measures, ensuring sustained compliance.
- Provided regular updates to leadership through structured reporting.
- Led the planning, organization, and execution of cross-functional programs, ensuring alignment with organizational goals.
- Led the successful implementation of TrackWise for Quality Management Systems (QMS) at Nashik, enhancing compliance and operational efficiency.
- Spearheaded the deployment of GSK Global Policies and Standards, ensuring seamless integration with site operations and regulatory frameworks.
- Directed the completion of the Greenfield 'Eltroxin Manufacturing Facility' project, establishing a state-of-the-art cGMP learning center to drive quality education and process excellence.
- Honored with GSK’s prestigious 'QMS Champion' award in recognition of leadership and contributions to quality system implementation and continuous improvement.
Quality Assurance Executive
Mylan Laboratories. Ltd.
01.2010 - 11.2014
- Managed Quality Management System (QMS) and Operational Quality, overseeing Change Controls, Deviations, Incident/Failure investigations, Laboratory incidents, Out-of-Specification (OOS) cases, CAPA management, Customer Complaints, Quality Alerts, and Root Cause Analysis (RCA).
- Led GAP analysis, Mock Recalls, and Non-Conformance resolutions.
- Implemented Quality Risk Management Systems, ensuring effective risk mitigation strategies in alignment with ICH Q9 guidelines.
- Conducted equipment, instrument, and area qualification reviews, monitoring process validation, cleaning validation, process qualification, and continued process verification to uphold regulatory and operational standards.
- Reviewed Batch Manufacturing Records (BMRs), Batch Packing Records (BPRs), Stability Protocols, Product Sampling Plans, Certificates of Analysis (COAs), Calibration & Validation records, ensuring accuracy and compliance.
- Collaborated with Quality Control teams to execute stability studies, reviewing and approving outcomes.
- Led internal audits as per the scheduled plan, tracking findings and ensuring timely resolution of compliance observations.
- Successfully implemented TrackWise Modules for Quality Management System (QMS) across Nashik, Aurangabad, Hyderabad, and Indore sites, enhancing compliance, efficiency, and data integrity.
- Led Operational Excellence (OPEX) projects, driving yield improvement, waste management optimization, and process enhancements to strengthen productivity and sustainability.
Quality Assurance Officer
Unimedico Lab Pvt. Ltd.
08.2008 - 12.2009
- Managed shop floor operations as part of the In-Process Quality Assurance (IPQA) team, overseeing end-to-end batch monitoring across the supply chain to ensure product integrity.
- Ensured all production operations complied with cGMP requirements and site procedures, maintaining adherence to specified product standards.
- Successfully executed regulatory filing projects, overseeing Exhibit and Commercial Validation batch monitoring and compiling essential data for submission.
- Led training programs, conducting staff and contingent worker training sessions on cGMP compliance, 5S methodology, housekeeping standards, and SOP implementation, aligning with scheduled training plans.
Education
M. Tech - Pharmaceutical Operation & Management
BITS Pilani
India01.2023
M.Sc. - Pharmaceutical Chemistry
H.N.B Garhwal University
India01.2008
B.Sc. - Biotechnology
H.N.B Garhwal University
India01.2006
Skills
- Strategic leadership and vision
- Regulatory expertise
- Quality management system mastery
- Digital transformation
- Operational excellence
- Data governance
- Cross-functional collaboration
- Supplier management
- Risk management
- Project management
- Mentorship and team development
- Third-party and CDMO manufacturing
Languages
- Fluent in Spoken and Written English
- Fluent in Spoken and Written Hindi
- Read, understand and speak Marathi
Affiliations
- Spearheaded global QMS harmonization across India and USA sites, aligning with US FDA, EMA, WHO, and TGA standards to ensure inspection readiness and regulatory compliance
- Led enterprise-wide digitization initiatives, including the implementation of MasterControl, Caliber LIMS, SAP, and e-BMR systems, enhancing data integrity and operational efficiency
- Directed successful regulatory inspections, including US FDA approval for Semglee the first interchangeable biosimilar through strategic audit preparation and cross-functional collaboration
- Established robust governance frameworks for deviation, CAPA, change control, and risk management, driving continuous improvement, and accountability
- Orchestrated supplier qualification and global audit programs, strengthening external partnerships, and ensuring end-to-end quality assurance across the supply chain
- Championed operational excellence through Lean Six Sigma methodologies, reducing process variability, and improving throughput across manufacturing and quality operations
- Oversaw computerized system validation (CSV) and 21 CFR Part 11 compliance, ensuring a secure, compliant digital infrastructure for quality data management
- Mentored and developed high-performing quality teams, fostering leadership succession, and a culture of ownership and regulatory excellence
- Collaborated with global stakeholders to align quality strategy with business objectives, influencing executive decision-making, and long-term growth
- Managed multimillion-dollar quality budgets and resource allocation, optimizing cost efficiency while maintaining compliance and innovation
Accomplishments
- Successfully led the first EMA and KFDA audits for Enzene Biosciences Ltd across two sites, achieving full regulatory clearance and global compliance alignment
- Implemented MasterControl suite, including Document Management, Learning Management, and Advanced Quality Event modules, alongside Caliber LIMS, transforming Enzene's digital quality infrastructure
- Spearheaded Biocon Malaysia's first successful USFDA and EMA inspections in 2020, maintaining uninterrupted regulatory approvals through 2024
- Directed successful ISO, GDPMD, and NPRA inspections for Biocon in 2021–2022, reinforcing adherence to international quality standards
- Played a pivotal role in securing U.S. FDA approval for Biocon’s Semglee, the first interchangeable biosimilar, through strategic quality oversight and regulatory coordination
- Championed enterprise-wide digitization at Biocon, deploying TrackWise (QMS), LMS, LIMS, and Documentum, enhancing compliance, efficiency, and data integrity
- Led quality improvement programs including human error reduction, 'I stand for quality,' CAPA ranking tools, and document simplification, driving measurable compliance gains
- Achieved successful USFDA, MHRA, TGA, and WHO audit outcomes across Macleods Pharmaceutical sites while executing digital transformation initiatives using TrackWise and Caliber LIMS
- Directed PMO efforts for Pfizer’s global inspections (USFDA, WHO, MHRA), implementing QMS digital tools, and leading transformational projects in aseptic manufacturing and lab enhancements
- Honored with multiple leadership awards from Biocon, Pfizer, and GSK—including 'Quality Excellence,' 'Own It,' and 'QMS Champion'—for outstanding contributions to global quality systems and continuous improvement
Certification
- Certificate in project management from IBMI, Berlin, Germany, 2020
- Computer system validation and 21 CFR Part 11, EU Annexure 11, and GAMP 5 compliance certification from Corporate Events India, India 2019
- Green Belt Certification in Six Sigma Process from IACT, India, 2015
- Certification in Quality Investigation System from Myaln Inc., 2014
- Diploma in Computer Application from LCC Academy, India, 2002
Languages
English
First Language
Hindi
Advanced (C1)
C1
Timeline
Global QMS and Digitization Head
Enzene Bioscience Ltd.
10.2024 - Current
Senior Manager (Worked as Quality and Digitization Lead)
Biocon Biologics Ltd.
01.2020 - 10.2024
Manager, Corporate Quality Assurance & Digitization
Macleods Pharmaceutical Ltd.
08.2018 - 11.2019
Manager, Quality Assurance
Pfizer Healthcare Ltd.
06.2016 - 07.2018
Manager, Corporate Quality Assurance
Abbott Healthcare Ltd.
12.2015 - 05.2016
Assistant Manager, Quality Assurance
GlaxoSmithKline Pvt. Ltd.
11.2014 - 12.2015
Quality Assurance Executive
Mylan Laboratories. Ltd.
01.2010 - 11.2014
Quality Assurance Officer
Unimedico Lab Pvt. Ltd.
08.2008 - 12.2009
M. Tech - Pharmaceutical Operation & Management
BITS Pilani
M.Sc. - Pharmaceutical Chemistry
H.N.B Garhwal University
B.Sc. - Biotechnology
H.N.B Garhwal University
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