Position Title: QMS and PV Compliance Manager
Job ID: 25-PJT00407M
Location: Bengaluru, India
About Astellas
Astellas Pharma Inc. is a global pharmaceutical company operating in more than 70 countries. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Our focus on addressing unmet medical needs with ethics and integrity drives our mission to improve health worldwide.
Learn more at www.astellas.com.
About Global Capability Centres (GCCs)
Astellas’ Global Capability Centres (GCCs) — located in India, Poland, and Mexico — serve as strategic hubs enabling access to world-class talent, operational efficiency, and innovation across the value chain. The GCCs strengthen Astellas’ resilience and support sustainable growth by co-locating core capabilities and accelerating delivery of VALUE to patients.
Position Purpose
The QMS and PV Compliance Manager is responsible for ensuring pharmacovigilance (PV) compliance across global operations. This role supports audit and inspection readiness, manages compliance metrics, performs root cause analyses, and ensures alignment with PV regulations, internal procedures, and quality standards.
Key Responsibilities
Conduct root cause analyses (RCA) for Individual Case Safety Reports (ICSRs) submitted late to health authorities, CROs, or business partners.
Enter RCA conclusions into the global safety database and perform data quality checks (QC).
Maintain and manage Excel-based RCA tracking tools and reports.
Lead weekly/bi-weekly meetings with case processing vendors to discuss compliance and RCA outcomes.
Support audit and inspection readiness activities for internal, external, and health authority reviews.
Collaborate with cross-functional teams, including local affiliate PV staff, Quality Assurance, Regulatory Affairs, and CRO partners.
Prepare and monitor compliance metrics, escalating trends or deviations as necessary.
Contribute to continuous improvement initiatives within PV compliance and QMS functions.
Facilitate effective communication between global PV stakeholders, vendors, and business partners.
Qualifications
Required
Bachelor’s degree (Science or related discipline).
Minimum 6 years of experience in the pharmaceutical, biotechnology, or related industry.
At least 4 years of experience in Pharmacovigilance, Regulatory Affairs, or Quality Assurance, with exposure to quality systems, standards, and metrics.
Preferred
Direct PV experience in a Quality or Compliance role.
Proficiency in Microsoft Excel (advanced functions, macros) and Power BI or similar tools.
Strong expertise in Root Cause Analysis (RCA) and Corrective and Preventive Actions (CAPA).
Proven ability to lead cross-functional meetings with internal and external partners.
Familiarity with global PV regulatory requirements and audit/inspection processes.
Work Environment
Based in Bengaluru, India (Astellas Global Capability Centre).
May require occasional travel for audits, inspections, or team meetings.
Join Us
Be part of a purpose-driven team that transforms cutting-edge science into innovative therapies for patients worldwide. If you are passionate about quality, compliance, and continuous improvement in pharmacovigilance, you belong at Astellas.
[Apply Now]
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