Purpose of the Role:- To lead the development of measurable quality objectives, conduct audits, deliver training, and monitor vendor performance to foster a culture of quality & continuous improvement with the objective of enhancing the Quality Management System (QMS) and ensuring compliance with regulatory, sponsor and Company's standards in clinical operations.
KRA & KPI:- These responsibilities are representative, and the role holder is also responsible for any other job assigned by the superior authorities from time to time. This section in not intended to be an exhaustive listing of all activities done by the role holder. It should capture only the key responsibilities of the role.
QMS Development:-
- Provide inputs to Quality Director in enhancing the company’s QMS and controlled documents related to clinical operations.
- Develop clear, measurable quality objectives aligned with the organization’s strategic goals and regulatory requirements in collaboration with Quality Maintenance Manager (QMM).
- Achieve communication of quality objectives across all levels of the organization to foster a culture of quality.
- Deliver quality-related training sessions to various teams to promote awareness and understanding of quality standards and practices.
Quality Assurance and Audit:-
- Implement regular internal audits (e.g. site audits, trial specific, data management etc.) and inspections to assess the effectiveness of the QMS and identify areas for improvement.
- Perform quality checks and audits of Trial Master File (TMF) documents (both paper and electronic) to ensure completeness and accuracy.
- Execute regular checks to confirm that clinical trial/study-specific plans are being followed at clinical sites and always achieve audit readiness.
- Generate audit reports highlighting process/ compliance gaps and provide recommendation for corrective actions.
- Interpret and consult on relevant regulations, guidelines, and standards affecting clinical trials.
Quality Documentation and Performance Reporting:-
- Develop clinical trial/study-specific quality metrics to provide insights to Quality Director into study team and site performance.
- Develop periodic reports detailing compliance and non-compliance trends, identifying potential risks, and presenting findings to the Quality Director.
- Monitor the external vendor/supplier qualifications and assess their performance by conducting audits.
- Review the completeness of clinical trial documentation such as reports, protocol deviations, CAPA etc. to ensure accuracy and compliance with regulatory standards.
Policies, Processes and Procedures :-
- Conduct day to day activities & follow all relevant policies, processes, standard operating procedures ensuring compliance with GCP, study protocols and sponsor guidelines.
- Keep self-abreast with leading quality practices & industry trends and contribute to the identification of continuous improvement of systems, processes and procedures.
- Achieve total compliance with the company’s Quality and Information Security Management Systems (ISMS) and relevant national and international legislation, including data protection laws.
- Draft and maintain clinical quality documents, including standard operating procedures (SOPs), guidelines, and template.
- Quality Management System (QMS) compliance rate across all sites (%)
- Milestone achieved (% delay)
- Quality of CAPA (# reduction in complaints/errors)
- Quality matrix review (as per schedule)
- CAPA resolution time (days)
- Audits completed on schedule (%)
- 360 degree feedback from colleagues, subordinates and supervisors.
- Training sessions conducted and/or attended (#)
- YoY reduction in quality related complaints/cases (#)
- Reduction in repeat quality complaints/cases (#)
- Site compliance (# audit points reported)
- Continuous improvement initiatives implemented (#)
- Regulatory compliance (# cases of data integrity reported)
Functional / Behavioral Skills:-
- Quality Management System design & implementation
- Local and international regulations, guidelines, and standards related to clinical trials, including GCP
- Audit
- Process Improvement methodologies e.g., Six Sigma, Lean
- Training
- Documentation
- Communication
- Collaboration
- Analytical Thinking
- Attention to detail
- Problem Solving
Education and Exp:-
- Bachelor in natural or health sciences or related field with a certification of knowledge of quality assurance standards
- 12 to 20 years’ experience in QMS and ISMS in Clinical Research Organizations and/or pharmaceutical companies with previous experience in system audits and/or inspections by certification bodies.
Pay: ₹5,000,000.00 - ₹9,000,000.00 per year
Benefits:
- Cell phone reimbursement
- Commuter assistance
- Flexible schedule
- Food provided
- Health insurance
- Internet reimbursement
- Leave encashment
- Life insurance
- Paid sick time
- Provident Fund
Work Location: In person
