Overview

DGM – Lead, Corporate Quality Internal Audit & Compliance Jobs in Mumbai Metropolitan Region at Glenmark Pharmaceuticals

Title: DGM – Lead, Corporate Quality Internal Audit & Compliance

Company: Glenmark Pharmaceuticals

Location: Mumbai Metropolitan Region

Purpose of the Role

To lead and strengthen Glenmark’s Corporate Quality Internal Audit and Compliance framework across global manufacturing sites and R&D laboratories by driving robust GMP compliance, effective internal audits, strong CAPA governance, and proactive regulatory risk mitigation, while engaging senior stakeholders through clear and impactful communication.

Key Responsibilities

Corporate Quality Audit Leadership

  1. Lead and manage the Corporate Quality Internal Audit Program for all Glenmark manufacturing sites (India and overseas) and applicable R&D laboratories.
  2. Develop, review, and maintain risk-based annual and multi-year audit plans, ensuring coverage of critical GMP systems, regulatory risk areas, and business priorities.
  3. Ensure timely planning, execution, reporting, and closure of internal audits in accordance with approved schedules.
  4. Select, qualify, and deploy competent internal auditors, ensuring audit independence, objectivity, and adherence to established auditing standards.
  5. Oversee preparation, review, and issuance of clear, concise, and technically sound audit reports, including grading of observations and compliance verification.

CAPA Governance & Regulatory Compliance

  1. Drive robust verification and effectiveness checks of CAPA across global sites, ensuring root-cause-based remediation and sustained compliance.
  2. Ensure commitments made to global health authorities are implemented within agreed timelines and verified for effectiveness.
  3. Periodically review and verify CAPAs arising from regulatory inspections, internal audits, and consultant audits.
  4. Maintain a centralised system to track audit observations, CAPA status, ageing, and follow-ups, with clear escalation mechanisms.

Regulatory Intelligence & Risk Management

  1. Trend and analyse regulatory inspection observations (US FDA, EU, MHRA, WHO, etc.) and internal audit findings to identify systemic gaps and emerging risks.
  2. Drive preventive actions and global improvement initiatives to reduce the likelihood of critical and major observations during regulatory inspections.
  3. Provide continuous GMP compliance surveillance across all sites to assess consistency of practices, data integrity, and quality systems maturity.

Systems, SOPs & Global Alignment

  1. Review and approve Corporate SOPs, Policies, and Global SOPs (GSOPs) to ensure regulatory compliance, clarity, and alignment with current industry practices.
  2. Ensure effective implementation of global SOPs versus site practices, identifying gaps and driving harmonisation across the network.
  3. Support lifecycle management of quality systems, ensuring alignment with evolving regulatory expectations.

Capability Building & External Interface

  1. Develop and mentor internal auditors at the site and corporate levels, including training on audit techniques, regulatory expectations, and effective communication.
  2. Coordinate and track external consultant audits and training activities, including definition of scope of work (SOW), deliverables, and performance evaluation.
  3. Act as a quality thought partner to site QA leaders, manufacturing, QC, and corporate stakeholders.

Reporting & Communication

  1. Prepare and present monthly dashboards, trend analyses, and management reports for senior leadership and Quality Councils.
  2. Lead face-to-face (F2F) discussions, reviews, and governance meetings with site leadership and corporate management.
  3. Demonstrate strong written and verbal communication skills, with the ability to clearly articulate compliance risks, expectations, and recommendations to technical and non-technical stakeholders.

Key Competencies & Skills

  • Strong technical expertise in pharmaceutical product manufacturing, Quality Assurance, Quality Control, and GMP systems
  • Deep understanding of global regulatory requirements (US FDA, EU, ICH, WHO)
  • Proven experience in internal audits, regulatory inspection readiness, and CAPA management
  • Excellent analytical, documentation, and data trending skills
  • Strong stakeholder management, influencing, and presentation skills
  • Ability to challenge constructively and drive a culture of quality and compliance
  • High standards of integrity, independence, and professionalism

Experience & Qualification (Indicative)

  • B.Pharm / M.Pharm / MSc (or equivalent); additional quality or auditing certifications preferred
  • 16+ years of progressive experience in pharmaceutical QA/QC/manufacturing, with significant exposure to corporate quality audits and regulatory inspections
  • Prior experience leading multi-site or global quality programs strongly preferred

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