Dr. Hema Bajaj
Affiliate Quality Officer - Heading Quality Assurance and Medical Excellence for Sanofi Pharma. Ops., India
Sanofi Aventis
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SUMMARY
- Senior professional with 11 plus years’ experience in Medical Quality and Marketing Compliance spreading across Promotional Ethics and Compliance, Product Quality, Drug safety, and Quality processes.
- Currently heading affiliate quality systems for Sanofi India Pharma and lead Clinical Quality and Marketing Compliance for Sanofi, India for 9 years.
- Have been instrumental in setting up novel electronic Transparency Platforms and implementing Quality/Compliance Systems at Sanofi India, in accordance with Sanofi Global Quality Policies, Quality Directives, Standards, International and local regulatory requirements.
- Areas of expertise include Quality Management, Project Management, Quality Assurance, Pharmacovigilance, Ethical Compliance, Business Excellence, Learning and Development.
HIGHLIGHTS of EXPERIENCE
- Marketing Ethics and Compliance: ensure compliance with industry standards like MCI rules, DoP, IFPMA, OPPI guidelines for ethical promotion, ethical interaction with healthcare professionals, medical institutions, patient organizations and implementation of transparency policy across all Sanofi Franchise (Pharma, Pasteur, Genzyme and Shantha Biothenics).
- Organizational Quality Management for Pharmacovigilance and other departments: Ensure Quality organization and management of Quality Documents to support Quality and Compliance Program for Pharmacovigilance, Medical Affairs Quality, and other departments.
- Project management: participate and lead team for business critical projects from start-ups to implementation for affiliate and region.
- Quality Management: Ensure Quality audits/ checks are conducted and hosted - internal and external customer audits, and inspections including company audits, system audits, process audits, site audits, and certification audits (e.g.; ISO certification, etc.)
- Training and tracking: ensure training of PV, Quality and Medical on company standards, and external stakeholders (KOLs, investigator teams, ethic committee members, etc.) across hospitals and institutions, on industry standards and regulations.
- Data analysis and reporting: Perform quality assurance consulting projects, data analysis and reporting for process improvements, product quality, PTCs.
- Team Management and Development: training and mentoring Pharmacovigilance and Quality, Medical Affairs team members; planning, assign
Summary
• Sr. professional with almost 11 yrs of experience in Clinical Research industry in leading & implementing of Affiliate Quality Systems in compliance with Company Standards & Regulatory requirements.
• Heading Clinical Quality & Medical Compliance for Sanofi, India since almost 7 years - Affiliate Quality Officer.• Key ability to provide Quality leadership across Organization with priority focus on GCP and health regulated activities.
• Key ability to work in matrix organization, collaborating with Business & Sr. Leadership of the Company.
• Expertise in: Quality Management & QA, Compliance, Project Management, Business Excellence, Training - Learning & Development
HIGHLIGHTS of EXPERIENCE
• Quality Assurance: conduct & host internal/external audits/inspections: system audits, process audits, site audits, vendor audits, & ISO certification audits. Manage Organizations Quality procedures
• Compliance: ensure compliance with industry stds: MCI rules, OPPI guidelines-ethical promotion, ethical interaction with external stakeholders, & implementation of transparency policy
• Project management: lead team for business critical projects from start-ups to implementation for affiliate/region
• Data analysis & Reporting: perform QA consulting projects, data analysis & reporting for process improvements
• People Management: training/mentoring team members, appraising performance & guiding professional development
• Regional role: collaborating with Region/South Asia for development & implementation of special projects
• Progressive experience in building teams & Quality dept. from inception
• Developing and managing company’s medical compliance program, aligning to applicable regulations, with focus on operations of Sales, Marketing, Comm.Ops. & Medical Affairs
• Training of team on company standards and regulations. Structuring & conducting clinical research trainings & workshops for over 100 KOLs & 60 hospitals across India.
Experience
Head of Clinical Quality & Medical Compliance - Affiliate Quality Officer
Sanofi India Limited.
- As a Quality lead for the affiliate, responsible for management of an appropriate affiliate quality system in India, with prime focus on quality aspects for Medical and Regulatory Affairs division, supporting Clinical Study Unit.
- Partner with the business to lead and coordinate the implementation business critical affiliate projects for India in compliance both with Sanofi quality standards and local regulatory requirements, concerning activities related to marketing, launch, clinical investigation of products developed and/or marketed in the country.- Bring Quality insight into the Governance and ways of working in place within the affiliate.
Head of Clinical Quality & Medical Compliance - Sr. Manager Clinical Quality.
Sanofi India Limited.
• Manage department and overall expectations pertaining to setting accurate schedules, costs and resources.
• Partner with Senior Leadership team and Management to identify team needs, quality gaps and implement solutions.• Be the local point of contact for the corporate Sanofi at affiliate level for initiating and implementing Quality systems across organization.
• Direct and lead the development of tools for risk assessment and audit techniques for use for quality management.
• Implement ongoing quality improvement processes working with interdepartmental teams in matrix organization.
• Develop and manage quality assurance metrics for performance improvement of all teams.
• Set up Systems, Process Mapping, Compliance Monitoring and Training on various company standards and regulations for ethical conduct of trials (GCP)
• Audit Related: provide necessary definition, development and deployment of clinical quality assurance strategy, per the requirement. Liaise with each concerned affiliate medical function to ensure continuous audit readiness by ad hoc connections with the expert groups in charge at Global level.
•Experience in API audits and Data management audit for third party.
- Develop compliance communications and undertake investigations of potential compliance issues in accordance with company policy. Prepare reports of compliance activities and metrics. Counsel and provide leadership with business partners on compliance process issues.
• Set up Quality Systems and ensure compliance to sanofi and industry standards for ethical Healthcare Professional, Healthcare Organization and Patient Association interactions.
• Quality Document Management: Develop and manage entire life-cycle of QD for medical division across divisions’ per identified requirements, global and local regulations.
• Trainings: Internal and industrry trainings.
• Metrics and Reporting.
Medical Quality Officer
Quintiles
Roles & Responsibilities
• Conducting interdepartmental audits in line with ISO requirements.
• Was instrumental in procuring first ISO 9001 – 2000 certification for Quintiles ECG Services division.• Conducting interdepartmental audits in line with ISO requirements.
• Support company auditor in conducting and hosting internal study audits and sponsor audits carried out on regular intervals.
• Perform quality assurance consulting projects, data analysis and reporting for process improvements.
• Perform Quality trend analysis presentations to the team and sending out monthly Quality Report to the Medical Director and Director of the organization.
• To act as the final level of quality control to ensure error free data reaches the site/sponsor.
• To collect and interpret error data at all levels and present error data of the unit on a regular basis, and present the quality trend report to the management.
Recruitment and Training Officer
Quintiles
Roles & Responsibilities
• Work with human resource manager and business leaders to craft talent strategy enabling hiring, development and retention of the best quality talent in the competitive environment.
• Screen and interview potential candidates’ esp. w.r.t. medical know-how and assist in the coordination of recruitment, selection and training of staff to meet specific requirements.• Work with human resource manager and business leaders to craft talent strategy enabling hiring, development and retention of the best quality talent in the competitive environment.
• Assist in various projects like Training Need Analysis, benching marking, competence mapping in order to ensure optimum resource utilization.
• Induction/Training of the new joinees and mentoring and managing resource allocation within the team.
• Support the performance management process for the assigned business, addressing performance issues, rewarding superior performance. Work closely with the human resource manager and business to identify top talent & reward them.
• Spearhead the ‘Talent Review’ process across the business and develop & deploy various structured talent management interventions.
• Develop & Deploy Role Based Training modules for the business.
Assistant Doctor
Homoeopathic Health Center
Managing the outpatient department. Assisting the Senior doctor in publications.Conducting trainings along with the team of doctors on various aspects of homoeopathy
Education
Institute of Clinical Research, Mumbai
Post Graduate in Clinical Research, Clinical Research, Rank Holder
Maharashtra University of Health Sciences
Bachelor in Homeopathic Medicine and Surgery, Homeopathic Medicine/Homeopathy, Rank Holder
Activities and Societies: Intercollegiate Debate Team, Intercollegiate Quiz Team
Certifications
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