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Manager – Development Quality Assurance (Inspection Readiness)

Sun Pharma
Sun Pharma
8-15 years
preferred by company
Gurgaon, Mumbai, India
1 May 14, 2026
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, mRS and EQ-5D-5L.

Manager – Development Quality Assurance (Inspection Readiness)

Location: Gurgaon, Haryana, India / Mumbai, Maharashtra, India
Employment Type: Full-Time
Department: Global Development Centre / Development Quality Assurance / Clinical Quality & Regulatory Compliance
Experience Required: 8–15+ Years (Significant Relevant Experience Required)


Job Overview

A strategic leadership opportunity is available for an experienced Manager – Development Quality Assurance (Inspection Readiness) within the global clinical quality and regulatory compliance domain. This role is ideal for professionals with deep expertise in clinical quality assurance, GxP compliance, regulatory inspections, CAPA management, clinical development oversight, inspection readiness, and global quality governance.

The selected candidate will be responsible for establishing and strengthening enterprise-wide inspection readiness across global development programs, ensuring sustained compliance with international health authority expectations and regulatory standards.

This is a high-impact role suited for professionals seeking advancement in clinical quality assurance, regulatory inspection management, development compliance, GCP quality systems, and pharmaceutical quality leadership.


Key Responsibilities

Global Inspection Readiness Strategy

  • Design, implement, and maintain a global inspection readiness framework across clinical development programs
  • Establish sustainable inspection preparedness processes aligned with regulatory expectations
  • Drive enterprise-wide readiness strategies using risk-based quality methodologies
  • Embed inspection excellence across development operations and quality systems

Regulatory Inspection Management
Lead readiness and inspection support for global regulatory agencies including:

  • US FDA
  • EMA
  • MHRA
  • PMDA
  • Other global health authorities

Responsibilities include:

  • Inspection preparation planning
  • Inspection execution support
  • Health authority interaction coordination
  • Inspection logistics management
  • Document readiness oversight
  • Subject Matter Expert (SME) preparation and coaching
  • Daily inspection debrief management

Clinical Quality & Compliance Oversight

  • Ensure sustained compliance with:
    • GxP regulations
    • ICH guidelines
    • Global clinical development quality standards
    • Regulatory compliance frameworks
  • Assess quality risks and compliance gaps across development operations
  • Support compliance governance across clinical and development functions

Mock Inspections & Risk Assessment

  • Lead:
    • Mock inspections
    • Readiness health checks
    • Gap assessments
    • Compliance risk reviews
    • Inspection simulations
  • Identify systemic compliance risks and implement mitigation strategies
  • Strengthen organizational inspection preparedness through proactive quality oversight

CAPA & Remediation Management

  • Lead post-inspection CAPA planning, execution, and effectiveness monitoring
  • Track audit actions and remediation commitments
  • Ensure timely closure of inspection-related findings
  • Drive sustainable corrective and preventive action strategies

Cross-Functional Quality Leadership
Collaborate closely with:

  • Clinical Development
  • Clinical Operations
  • Regulatory Affairs
  • Pharmacovigilance
  • Biometrics
  • Data Management
  • Quality teams
  • CROs
  • External vendors
  • Global regional inspection teams

Act as a strategic quality partner to support operational readiness and compliance excellence.

Governance, Reporting & Metrics

  • Define and monitor inspection readiness KPIs
  • Support governance reporting and compliance dashboards
  • Communicate inspection risk and compliance posture to senior leadership
  • Provide strategic quality updates and readiness insights

Training & Capability Development

  • Develop and deliver inspection readiness training programs
  • Coach internal SMEs, operational teams, and study personnel
  • Support onboarding and ongoing quality education initiatives
  • Facilitate lessons-learned workshops and inspection readiness forums

Vendor & External Partner Oversight

  • Support inspection preparedness assessments for:
    • CROs
    • Third-party vendors
    • Clinical partners
    • External development stakeholders
  • Ensure external partners maintain inspection-ready compliance standards

Required Qualifications

Educational Qualifications
Candidates must hold:

  • Bachelor’s Degree in:
    • Life Sciences
    • Pharmacy
    • Nursing
    • Related healthcare or scientific disciplines

Preferred:

  • Master’s Degree