JOB LOCATION :- Expecto Health Science, Kharghar, Navi Mumbai-410210.
Expecto Health Science is a fast-growing full-service Clinical Research Organisation (CRO) headquartered in Singapore, focused on delivering high-quality clinical development solutions across the Asia-Pacific region.
About the Role
We are looking for an experienced and dynamic Head / Director – Quality Assurance to lead and strengthen the Quality Management System (QMS) for our Clinical Research Organization (CRO). The role will be responsible for ensuring compliance with ICH-GCP, applicable regulatory requirements, sponsor expectations, and internal quality standards.
Key Responsibilities
Lead the Quality Assurance function and drive organization-wide quality initiatives.
Develop, implement, maintain, and continuously improve the Quality Management System.
Plan and conduct internal audits, vendor audits, investigator site audits, study audits, and process audits.
Review audit observations, identify root causes, and ensure timely CAPA implementation and effectiveness checks.
Support regulatory inspections, sponsor audits, and client quality assessments.
Review and approve SOPs, policies, quality procedures, templates, and quality records.
Monitor quality metrics, deviations, non-conformances, complaints, and inspection readiness activities.
Provide quality guidance to Clinical Operations, Data Management, Medical Writing, Pharmacovigilance, Regulatory Affairs, and other functional teams.
Conduct quality training and compliance awareness programs across the organization.
Lead risk assessment activities and promote a quality culture across departments.
Prepare periodic QA reports and management review presentations for senior leadership.
Manage and mentor the QA team and support resource planning and performance management.
Required Qualifications
Experienced Bachelor’s or Master’s degree in Life Sciences, Pharmacy, or related field. Minimum 5 years in a leadership or people management role.
Minimum 12–15 years of experience in Quality Assurance within the Clinical Research (CRO).
Hr# 8369371050
Pay: ₹800,000.00 - ₹2,000,000.00 per year
Benefits:
- Health insurance
- Paid sick time
- Paid time off
- Provident Fund
Ability to commute/relocate:
- Kharghar, Navi Mumbai, Maharashtra: Reliably commute or planning to relocate before starting work (Preferred)
Application Question(s):
- How many year of experience do you have in Quality Assurance within Clinical Research (CRO)?
- Expected Salary?
Work Location: In person
