Purpose of the Role:- To provide comprehensive leadership in establishing and maintaining a robust quality management system that ensures compliance with regulatory requirements, relevant local and international standards, and sponsor guidelines, which aims to enhance the quality of clinical trials worldwide, promote continuous improvement, and cultivate a culture of quality excellence that supports the organization’s strategic objectives and enhances customer satisfaction
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.
- Timeliness and effectiveness of the quality assurance roadmap
- Quality Management System (QMS) compliance rate across all sites (%)
- Milestone achieved (% delay)
- Audits completed on schedule (%)
- YoY reduction in quality related complaints/cases (#)
- Reduction in repeat quality complaints/cases (#)
- ite compliance (# audit points reported)
- Continuous improvement initiatives implemented
- Regulatory compliance (# cases of data integrity reported)
- Study Score Card (score)
- Voluntary attrition (%)
- Training sessions conducted and/or attended
- 360 degree feedback from colleagues, subordinates and supervisors
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.
Strategy and Planning:-
- Provide inputs in creating short to mid-term quality assurance strategy globally and create a roadmap in line with business objectives and global, local geography requirements.
- Oversee end to end development and implementation of overall quality plan including company’s Clinical Trial Quality Management System (QMS), quality objectives etc. for different functions and across all sites.
- Collaborate with different function heads to provide quality assurance leadership across multiple regions to address local site-specific challenges and regulations.
- Review industry trends/best practices in clinical quality management, recommend improvements to existing quality assurance frameworks and practices.
Quality Management System (QMS):-
- Oversee the development of quality metrics for the company and clinical trials/studies to provide executive and operational insights into study teams’ and sites’ performance.
- Perform quality co-monitoring visits to assess operations that affect clinical trial/study quality and compliance.
- Engage in the interpretation and consultation on relevant local and international regulations, guidelines, and standards and translate actionable to downstream team.
- Participate in management review meetings and present functional performance, suggest strategic initiatives and improvement areas to strengthen quality in clinical operations. Promote organizational awareness on quality management, regulatory compliance and clinical trial standards through appropriate forums.
Quality Audit
- Oversee the implementation and periodic updating of internal audit program ensuring due considerations of regulatory requirements and risk mitigation strategy.
- Preside and perform periodic internal audits of study team operations, investigator sites, and suppliers to review adherence to established standards.
- Preside over audit mandates received from clients or competent authorities and certification bodies ensuring audit readiness.
- Review recurring quality issues highlighted in audit reports and undertake sustained efforts to optimize quality processes.
Policies, Processes and Procedures :-
- Oversee creation and ensure implementation of approved policies, processes, procedures and monitor their adherence so that work is carried out in a controlled manner.
- Oversee company compliance with applicable local and international legislations and clinical trials/studies compliance with GCP, protocols, local and international legislation, Company and Sponsor SOPs, policies, guidelines and company's Quality and Information Security Management Systems.
- Promote a culture of innovation, high quality and continuous improvement through adapting to changes in standards, changes in the business environment and adoption of leading practices.
- Oversee escalated non-compliance cases and recommend processes to reduce non-compliance.
People Management:-
- Instill a culture of continuous development and performance within the quality team
- Lead by example by encouraging teamwork, driving results and excellence, developing and grooming talent and demonstrating role modelling behavior
- Proactively participate in recruiting, development & engagement of own team
- Set and communicate clear performance expectations, coach and provide support and regular feedback to own team
- Evaluate training and development requirements for quality team and make recommendations for learning interventions
Functional / Behavioral Skills:-
- Quality Management System designing, implementing, and maintenance
- Local and international regulations, guidelines, and standards related to clinical trials, including GCP
- Audit
- Risk Management
- Process Improvement methodologies e.g., Six Sigma, Lean
- Strategy and Planning
- Influence
- Customer Focus
- Communication
- Enable Change
- Attention to detail
- Coaching
- People management
Education and Exp:-
- Masters in natural or health sciences or related field with a certification in quality assurance and clinical trials standards (e.g., ISO 9001, ICH GCP, etc.)
- 15 years’ experience in clinical research organization and or pharmaceutical organization preferably in managing quality systems, conducting system and site audits and hosting regulatory inspections.
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
