Assistant Manager - Compliance Management

Soterius Life Sciences; Mumbai; On-site; INR 2,500,000 - 4,000,000; Full time

Job summary

Soterius Life Sciences is seeking an experienced Quality Lead to manage the quality management system for a large pharmacovigilance program. You will ensure compliance, drive CAPA activities, and prepare for regulatory inspections across all functions.

The role requires expertise in PV quality processes, audit readiness, and KPI/SLA reporting. Collaboration with clients and internal teams is essential to maintain high standards of quality and safety compliance.

Qualifications

• Experience leading a quality management system across PV operations.
• Experience with deviations, CAPA and root cause analysis.
• Audits and regulatory inspections readiness experience.

Responsibilities

• Own and maintain the QMS across the PV operation.
• Lead deviation and CAPA management including root cause analysis and effectiveness checks.
• Drive audit and inspection readiness and lead quality responses during regulatory inspections and client audits.
• Monitor compliance against regulatory timelines and internal SLAs, escalate risks.
• Own SOP and controlled document management including review and version control.
• Conduct quality trend analysis across case processing and reports to drive corrective action.
• Maintain dotted-line relationship with client quality contact and support governance.
• Deliver quality metrics and KPI/SLA reporting to Director Safety and client.

Skills

PV administration

KPI SLA reporting

MIS reporting

Compliance trackers

Document management

Scheduling & meeting coordination

Client & internal coordination

Safety database support

Education

Degree in Pharmacy, Medicine, Pharm D, BHMS, BDS or equivalent

Job description

Role Overview

Accountable for the quality management system, compliance, and inspection readiness of a large OTC/consumer healthcare pharmacovigilance program handling large volume cases per year. Report to the Director Safety and operate independently of the delivery line to provide objective quality oversight across all functions.

Key Responsibilities

• Own and maintain the quality management system across the entire PV operation.
• Lead deviation and CAPA management, including root cause analysis and effectiveness checks.
• Drive ongoing audit and inspection readiness and lead the quality response during regulatory inspections and client audits.
• Perform compliance monitoring against regulatory timelines and internal SLAs, identifying and escalating risks.
• Own SOP and controlled document management, including periodic review and version control.
• Conduct quality trend analysis across case processing, aggregate reports, literature, and affiliate functions, and drive corrective action.
• Maintain a dotted-line relationship with the client quality contact and support client quality governance.
• Deliver quality metrics and KPI/SLA compliance reporting to the Director Safety and client.

Qualification

Degree in Pharmacy, Medicine, Pharm D, BHMS, BDS or equivalent

Key Skills

• PV administration and coordination
• KPI, SLA and metrics reporting
• MIS reporting
• compliance trackers
• Document management
• Scheduling and meeting coordination
• Client and internal team coordination
• Safety database operational support

Required Skills

• Quality management
• KPI/SLA Compliance
• Quality Trend Analysis
• Client Quality Governance
• Audit and inspection readiness
• Root Cause Analysis
• Deviation and CAPA
• Compliance Monitoring

We are an equal opportunity employer committed to fostering a diverse, inclusive, and respectful workplace.

We welcome applications from all qualified candidates and do not discriminate on the basis of race, colour, religion, gender, gender identity or expression, sexual orientation, age, disability, marital status, or any other characteristic protected by applicable law.

Employment decisions are based on qualifications, skills, experience, and business needs.