Job Title: Associate Manager – Quality Assurance
Date Posted: 29 Aug 2025
Location: Bangalore, Karnataka, India
About the Company
Indegene is a technology-led healthcare solutions provider with a mission to enable healthcare organizations to be future-ready. We provide accelerated global career growth opportunities for talent that is bold, industrious, and nimble.
At Indegene, you will:
Work at the exciting intersection of healthcare and technology.
Be mentored by some of the brightest minds in the industry.
Gain exposure to a high-speed, global fast-track career.
Thrive in a culture of innovation, collaboration, empathy, and customer obsession.
Learn more at: www.careers.indegene.com
Role Overview
The Associate Manager – Quality Assurance will be responsible for developing, implementing, and overseeing pharmacovigilance (PV) quality management systems to ensure regulatory compliance, inspection readiness, and continuous improvement across PV activities.
Key Responsibilities
1. Quality Management
Develop, review, and update PV policies, procedures, and SOPs to ensure compliance.
Monitor and report on PV compliance metrics and trends.
Support implementation and maintenance of PV quality management systems.
Manage adverse event evaluation and ensure compliance with reporting timelines and quality standards.
Conduct root cause analysis (RCA) and implement corrective and preventive actions (CAPA).
Present quality data to internal stakeholders in relevant forums.
Ensure adherence to all internal and client training requirements.
2. Training and Support
Deliver training on PV regulations, compliance requirements, and company SOPs.
Act as a subject matter expert (SME) for PV compliance-related queries.
Develop training and development plans for team members.
Create onboarding and role-specific training programs for new hires.
3. Risk Management
Identify, assess, and mitigate risks related to PV activities.
Develop and maintain risk management plans and implement mitigation strategies.
4. Documentation and 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 while supporting global quality initiatives.
5. Regulatory Compliance & Late Case Analysis
Ensure compliance with global PV regulations (FDA, EMA, ICH, MHRA).
Stay updated with changes in PV regulations and implement necessary updates.
Conduct investigations into delays in case processing and submission.
6. Cross-functional Collaboration
Collaborate with Clinical, Regulatory Affairs, and other Quality functions to align PV activities.
Participate in cross-functional initiatives to strengthen PV compliance.
Skills & Competencies
Core Skills:
Strong attention to detail.
Critical thinking and analytical skills.
Good comprehension, written, and verbal communication skills (English).
Proficiency in MS Excel.
Good interpersonal skills.
Nice to Have:
Team and people management experience.
Certification in Quality Management Systems (QMS).
Equal Opportunity Statement
Indegene is an Equal Employment Employer committed to fostering inclusion and diversity.
We do not discriminate on the basis of race, religion, sex, color, age, national origin, pregnancy, sexual orientation, physical ability, or any other characteristic. Employment decisions are based on business needs, merit, and qualifications.
All qualified applicants will receive consideration without regard to race, religion, sex, national origin, gender identity, sexual orientation, disability status, protected veteran status, or any other characteristic.
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Ranchi |Karnataka :
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Bulgaria | Vedant |Denmark :
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France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Brinny | Ringaskiddy |County Dublin :
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Galway |Meath :
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China | Quarry Bay |Hubei :
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Sheffield |United Kingdom :
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Brussels |Flemish Brabant :
Zaventem |Bosnia and Herzegovina :
Sarajevo |Sofia City :
Sofia |Canada :
Canada |Ontario :
Renfrew | North York | Australia | Mississauga | Richmond Hill | Uxbridge |Quebec :
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Croatia |Zagreb :
Zagreb |Bohemia :
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Japan | Saitama |Tokyo :
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Remote Korea |Republic of Korea :
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Brazil | Sao paulo |South America :
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Sweden |Taipei :
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