Job Title: Associate Manager – Quality Assurance
Date Posted: 29 Aug 2025
Location: Bangalore, KA, India
Company Overview:
Indegene is a technology-led healthcare solutions provider enabling healthcare organizations to be future-ready. The company offers accelerated global growth opportunities for talent that is bold, industrious, and nimble. Employees gain a unique career experience guided by passion, innovation, collaboration, and empathy.
Key highlights:
Exposure to pharmacovigilance (PV) quality management and compliance
Mentorship from industry experts
Fast-track global career growth opportunities
Role Purpose:
The Associate Manager – Quality Assurance is responsible for ensuring compliance, quality, and regulatory adherence in pharmacovigilance processes. The role involves overseeing PV activities, training staff, risk management, documentation, and cross-functional collaboration.
Key Responsibilities:
1. Quality Management:
Develop, review, and update PV policies, procedures, and SOPs to ensure compliance and currency.
Monitor and report PV compliance metrics and trends.
Implement and maintain PV quality management systems.
Oversee evaluation and consistent handling of adverse events, ensuring reporting timelines and quality standards are met.
Communicate observations to stakeholders and ensure proper root cause analysis (RCA) and corrective/preventive action (CAPA).
Present quality data to internal stakeholders and attend internal/client trainings.
2. Training and Support:
Provide training on PV regulations, compliance requirements, and company SOPs.
Act as a subject matter expert for PV compliance queries.
Set up development plans for team members to enhance skills and potential.
Design training plans for new hires 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 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, supporting global quality and compliance initiatives.
5. Regulatory Compliance and Late Case Analysis:
Ensure compliance with global PV regulations and guidelines (e.g., FDA, EMA, ICH, MHRA).
Stay updated on changes in PV regulations and implement adjustments.
Conduct investigations into root causes of delayed case processing and submissions.
6. Cross-functional Collaboration:
Work with Clinical, Regulatory Affairs, and QA departments to ensure coordinated PV activities.
Participate in cross-functional teams for PV compliance initiatives.
Skills & Competencies:
Strong attention to detail
Critical thinking and analytical skills
Good comprehension skills
Excellent communication (verbal and written) and interpersonal skills
Proficiency in Excel
Nice to have:
Team and people management experience
Certification in Quality Management Systems (QMS)
Equal Opportunity:
Indegene is committed to a culture of inclusion and diversity. Employment decisions are based on business requirements, merit, and qualifications.
All qualified applicants will receive consideration without regard to:
Race, color, religion, sex, national origin
Gender identity or sexual orientation
Disability status or protected veteran status
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