Job Title:
Associate Manager – Quality Assurance
Employer:
Indegene
Location:
Bangalore, Karnataka, India
Date Posted:
27 September 2025
About the Company:
Indegene is a technology-led healthcare solutions provider focused on enabling healthcare organizations to be future-ready. The company emphasizes entrepreneurship, innovation, collaboration, and empathy, offering accelerated global growth opportunities. Employees are mentored to thrive at the intersection of healthcare and technology.
Job Purpose:
The Associate Manager – Quality Assurance is responsible for ensuring compliance with pharmacovigilance (PV) regulations and quality standards, overseeing PV processes, risk management, training, and cross-functional collaboration to maintain high-quality standards and regulatory compliance.
Key Responsibilities:
1. Quality Management
Develop, review, and update PV policies, procedures, and SOPs to ensure compliance.
Monitor and report PV compliance metrics and trends.
Support the implementation and maintenance of PV quality management systems.
Manage QA processes, ensuring consistent handling of adverse events and compliance with reporting timelines.
Communicate observations to stakeholders and ensure RCA/CAPA are implemented.
Present quality data to internal stakeholders.
Attend internal and client trainings to maintain compliance awareness.
2. Training & Support
Provide training on PV regulations, compliance requirements, and SOPs.
Act as subject matter expert for PV compliance queries.
Develop individual training and development plans for team members.
Ensure new hires receive appropriate training based on experience and job role.
3. Risk Management
Identify, assess, and mitigate risks related to PV activities.
Develop and maintain risk management plans and ensure timely execution of 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; support global initiatives to enhance quality and compliance.
5. Regulatory Compliance & Late Case Analysis
Ensure compliance with global PV regulations and guidelines (e.g., FDA, EMA, ICH, MHRA).
Stay updated with regulatory changes and implement necessary adjustments.
Conduct investigations into delays in case processing and submission.
6. Cross-Functional Collaboration
Collaborate with Clinical, Regulatory Affairs, and QA teams to ensure coordinated PV activities.
Participate in cross-functional teams to support PV compliance initiatives.
Skills & Competencies:
Must-Have Skills
Attention to detail
Critical thinking and analytical skills
Strong comprehension skills
Excellent verbal and written communication (fluent in English)
Good interpersonal skills
Proficiency in Excel
Nice-to-Have Skills
Team and 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 qualification, without discrimination based on race, religion, sex, color, age, national origin, pregnancy, sexual orientation, physical ability, or any other protected characteristics.
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