Associate Manager – Quality Assurance
Date Posted: 29 Aug 2025
Location: Bangalore, KA, India
Company Overview
Indegene is a technology-led healthcare solutions provider, committed to enabling healthcare organizations to be future-ready. We offer accelerated global growth opportunities and a career experience guided by entrepreneurship, innovation, collaboration, and empathy.
Work at the intersection of healthcare and technology.
Mentorship from industry experts.
Fast-track global career growth.
Purpose-driven, customer-focused culture.
Learn more: www.careers.indegene.com
Role Overview
The Associate Manager – Quality Assurance will oversee pharmacovigilance (PV) quality and compliance activities, ensuring adherence to global regulations, company SOPs, and quality standards. This role involves managing PV processes, training staff, mitigating risks, and reporting to senior management.
Key Responsibilities
1. Quality Management:
Develop, review, and update PV policies, procedures, and SOPs.
Monitor PV compliance metrics and trends.
Support implementation and maintenance of PV quality management systems.
Direct and control QA processes for adverse events, ensuring timely reporting and compliance.
Conduct root cause analysis (RCA) and implement corrective and preventive actions (CAPA).
Present quality data to internal stakeholders.
Participate in internal and client trainings, ensuring compliance with guidelines.
2. Training & Support:
Provide PV training to relevant staff.
Act as a subject matter expert for PV compliance queries.
Set up development plans and training programs for team members and new hires.
Ensure completion of all internal and client training requirements.
3. Risk Management:
Identify, assess, and mitigate PV-related risks.
Develop and maintain risk management plans and implement mitigation strategies.
4. Documentation & Reporting:
Ensure accurate and timely documentation of compliance activities.
Prepare compliance reports for senior management and regulatory authorities.
Maintain inspection readiness documentation.
Review, author, and update SOPs and support global quality initiatives.
5. Regulatory Compliance & Late Case Analysis:
Ensure compliance with global PV regulations (FDA, EMA, ICH, MHRA).
Stay up-to-date with changes in PV regulations and implement necessary adjustments.
Investigate root causes for delayed case processing and submissions.
6. Cross-functional Collaboration:
Collaborate with Clinical, Regulatory Affairs, and QA departments for coordinated PV activities.
Participate in cross-functional teams supporting PV compliance initiatives.
Skills & Competencies
Must-Have:
Attention to detail
Critical thinking and analytical skills
Strong comprehension and problem-solving skills
Excellent verbal and written communication in English
Interpersonal skills for collaboration across teams
Proficiency in Microsoft Excel
Nice-to-Have:
Team management or people management experience
Certification in Quality Management Systems (QMS)
Equal Opportunity Statement
Indegene is an Equal Employment Employer, committed to inclusion and diversity. Employment decisions are based on business requirements, merit, and qualifications without discrimination based on race, religion, sex, color, age, national origin, pregnancy, sexual orientation, physical ability, or other protected characteristics.
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