Job Title: Associate Manager – Quality Assurance
Date Posted: 29 August 2025
Location: Bangalore, Karnataka, India
About Indegene
Indegene is a technology-led healthcare solutions provider committed to helping healthcare organizations become future-ready. We operate at the cutting edge of healthcare and technology, offering a unique environment where innovation, collaboration, and entrepreneurial thinking thrive.
At Indegene, you’ll work alongside passionate professionals who are redefining healthcare solutions globally. We offer accelerated career growth, a high-impact work environment, and mentorship from industry leaders.
To explore more, visit: www.careers.indegene.com
Role Overview
As an Associate Manager – Quality Assurance, you will play a key role in ensuring that pharmacovigilance (PV) activities meet global regulatory compliance and quality standards. You will lead QA initiatives, support training and development, manage risks, ensure documentation accuracy, and collaborate cross-functionally to uphold the highest standards of PV practice.
Key Responsibilities
1. Quality Management
Develop, review, and maintain SOPs, policies, and procedures for PV compliance.
Monitor PV quality metrics and identify trends or gaps.
Manage and control quality assurance processes related to adverse event handling and timelines.
Perform root cause analysis (RCA) and implement corrective and preventive actions (CAPAs).
Present QA findings to internal stakeholders.
Ensure attendance in all internal and client trainings related to quality and compliance.
2. Training and Support
Conduct training sessions on PV regulations, SOPs, and compliance standards.
Act as a Subject Matter Expert (SME) for PV-related queries.
Develop personalized training plans for new hires and existing team members.
Support team development by identifying skill gaps and creating growth plans.
3. Risk Management
Proactively identify, assess, and mitigate risks in PV activities.
Develop and maintain risk management plans.
Execute timely risk mitigation strategies.
4. Documentation and Reporting
Ensure accurate documentation of compliance-related activities.
Prepare quality and compliance reports for internal and external stakeholders.
Maintain inspection-readiness and audit documentation.
Author, review, and update SOPs to meet global quality standards.
5. Regulatory Compliance & Late Case Analysis
Ensure alignment with global PV regulations (FDA, EMA, ICH, MHRA).
Monitor updates in regulatory guidelines and implement necessary organizational changes.
Conduct detailed investigations into late case processing and identify root causes.
6. Cross-functional Collaboration
Coordinate with Clinical, Regulatory Affairs, and other departments to ensure compliance in PV-related operations.
Participate in cross-functional initiatives to drive quality and process improvements.
Required Skills & Qualifications
Must Have:
Strong attention to detail.
Critical thinking and analytical abilities.
Excellent comprehension and written/verbal communication skills in English.
Proficiency in Microsoft Excel.
Good interpersonal and collaboration skills.
Nice to Have:
Experience in team and people management.
Certification in Quality Management Systems (QMS) or equivalent.
Personal Attributes
Strong ownership and accountability mindset.
Ability to multitask and work in a dynamic, fast-paced environment.
Desire for continuous learning and improvement.
Comfortable in mentoring and coaching team members.
Equal Opportunity Statement
Indegene is proud to be an Equal Employment Opportunity (EEO) employer and is committed to a culture of inclusion and diversity.
We make all employment decisions—hiring to separation—based on business needs, qualifications, and merit, without regard to race, religion, gender, age, disability, sexual orientation, gender identity, national origin, or any other protected status.
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