Epoch Consulting Pvt. Ltd. is hiring for the below position for its client, a leading Contract Research Organization which is providing Clinical Research Services.
Our Client is a Contract Research Organization that was established in 2015 with a formidable team and experiences in Clinical Trials Phase I to Phase IV and Pharmacovigilance services.
Our Client continuously aims to design and provide quality and cost-efficient processes to make India a global leader in ethical clinical research. It provides comprehensive solutions in Clinical Project Management, Medical Writing, Regulatory Affairs, Data Management, and other core clinical trials solutions along with clinical safety and pharmacovigilance.
Industry: Clinical Research / CRO
Department: Quality Assurance
Location: Noida
Employment Type: Full-Time
The Director – Quality Assurance (QA) will lead and oversee the organization’s Quality Management System (QMS) for all clinical research operations within the CRO. The role is responsible for ensuring compliance with applicable global and local regulatory requirements, including ICH-GCP, CDSCO, US FDA, EMA, MHRA, and other international standards relevant to clinical trials, pharmacovigilance, bioavailability/ bioequivalence studies, and related clinical research activities.
- Review and Approval of Protocols, Reports and associated Deviations as applicable.
- Maintain SMF (Site Master File), Validation Master Plans & Inventory of systems.
- Conducts training as required.
- Generation of SOPs/ other documentation as applicable.
- Maintain change control system.
- Handling of quality elements (Change control, deviation CAPA, QRM, SOP, Quality metrics).
- Lead the development, implementation, and maintenance of the organization’s Quality Management System (QMS).
- Ensure compliance with applicable regulations and guidelines, including:
- ICH-GCP
- FDA regulations
- EMA requirements
- Applicable GxP standards
- Internal SOPs and sponsor requirements.
- Develop, review, approve, and maintain quality policies, SOPs, and quality standards.
- Monitor changes in global regulations and assess organizational impact.
- Plan, manage, and oversee internal and external audits, including:
- Investigator site audits
- Vendor audits
- Process and system audits
- Trial Master File (TMF) reviews.
- Lead organizational readiness for sponsor audits and regulatory inspections.
- Ensure timely resolution of audit findings and regulatory observations.
- Oversee Corrective and Preventive Action (CAPA) processes, including root cause analysis and effectiveness checks.
- Implement risk-based quality management strategies to support proactive compliance oversight.
- Support vendor qualification, evaluation, and oversight activities.
- Lead and mentor QA staff and cross-functional quality teams.
- Support GxP and compliance training initiatives across the organization.
- Provide strategic QA guidance to senior leadership and project teams.
- Bachelor’s degree in Life Sciences, Pharmacy, Nursing, Biotechnology, or related field required.
- Advanced degree preferred.
- Minimum 10 years of experience in Quality Assurance within the pharmaceutical, biotechnology, or CRO industry.
- At least 5 years in a leadership or management role.
- Strong experience in GCP/GxP compliance and quality systems management.
- Demonstrated experience managing regulatory inspections and client audits.
- In-depth knowledge of ICH-GCP, FDA, EMA, and global regulatory requirements.
- Strong understanding of quality systems, CAPA management, and risk-based quality approaches.
- Excellent leadership, communication, and stakeholder management skills.
- Strong analytical, problem-solving, and organizational abilities.
- Experience with electronic QMS systems and audit management tools preferred.
- Strategic Leadership
- Regulatory & Compliance Expertise
- Audit & Inspection Management
- Risk Assessment & Mitigation
- Process Improvement
- Team Development
- Cross-Functional Collaboration
- Attention to Detail
- Ethical & Professional Integrity
Website: Website and Company name will be shared
Working Days: 5.5 Days Working [1st n 3rd Saturday is working, 2nd and 4th saturday will be off]
Job Type: Full-Time, Permanent
