DGM / GM Compliance (Pharma Industry)

Pharma Placements Inc.; Mumbai; Hybrid; INR 4,000,000 - 5,000,000; Full time

Benefits offered by this job

Extensive travel across sites

Job summary

Pharma Placements Inc. is seeking an experienced DGM - GM Compliance to drive governance across multiple manufacturing sites in Mumbai. The role involves extensive travel, oversight of data integrity, and ensuring adherence to global regulatory standards, including USFDA, MHRA, EDOM, GAMP5, PICs, and TGA.

The ideal candidate will lead risk management, internal controls, and QA processes across sites, shape policies, and coordinate audits and CAPA activities through a robust QMS.

Qualifications

• Senior pharmaceutical quality/compliance professional with strong experience in corporate compliance, regulatory audits, QMS, data integrity and multi-site manufacturing operations.

Responsibilities

• Data integrity governance across all sites and governance framework implementation.
• Influence business units to manage risk, improve internal controls and develop compliant solutions.
• Monitor internal and external environments to identify risks, gaps and issues.
• Ensure systems and procedures align with regulations through audits (USFDA, MHRA, EDOM, GAMP5, PICs, TGA).
• Review quality management systems including change control, deviation, CAPA, complaints, recalls, OOS/OOT via audits.
• Independently assess site compliance health using a risk-based approach.
• Advise on development and implementation of departmental procedures and compliance policies.
• Assist teams in corrective and preventive actions.
• Facilitate compliance training and design training modules on technical, regulatory topics.
• Identify compliance hot spots and verify compliance across unit operations.
• Coordinate all compliance activities across sites including training, reporting and investigations.
• Audit materials and finished dosage forms per EU GMP/ICH guidelines and assess pharmacovigilance as per GVP/ICH.

Skills

Data integrity governance

Regulatory audits

Risk management

Internal controls

Audit of computer system validation

Policy & procedure development

Training & awareness

Site compliance health assessment

Cross-site coordination

Job description

A Highly renowned and fast growing pharmaceutical organisation is looking for an experienced DGM - GM Compliance to drive compliance governance across multiple manufacturing sites.

• Location: Mumbai
  Level: DGM / GM Corporate Compliance
  CTC: 40 to 50 LPA, depending on current package, Skill set and experience
  Reporting to: Director
• Extensive travel across manufacturing sites will be involved

Key Responsibilities:

• Data Integrity & Compliance Governance
  • Implement data integrity governance and compliance across all sites of the company.
• Risk Management & Internal Controls
  • Influence business units to manage risk, improve internal controls, and develop compliant business solutions.
• Monitoring & Assessment
  • Continuously monitor internal and external environments to identify key risks, gaps, and compliance issues.
• Regulatory Audits & System Checks
  • Ensure systems and procedures align with regulations (USFDA, MHRA, EDOM, GAMP5, PICs, TGA) through audits.
  • Review quality management systems (Change control, Deviation, CAPA, Complaints, Recalls, OOS/OOT) via audits.
  • Audit computer system validation processes.
• Site Compliance Health
  • Independently assess compliance health of each site using a risk-based approach.
• Policy & Procedure Development
  • Advise on and support the development and implementation of departmental procedures and compliance policies.
• Corrective & Preventive Actions
  • Assist teams in assessing and implementing corrective and preventive actions.
• Training & Awareness
  • Facilitate compliance training at sites.
  • Design and prepare training modules on technical, compliance, regulatory, and soft skill topics.
• Site Operations & Hot Spot Identification
  • Identify compliance hot spots and conduct unit operations to verify compliance levels.
• Coordination of Compliance Activities
  • Coordinate all compliance-related activities across all manufacturing sites of the company, including training, procedures, communications, reporting, auditing, monitoring, enforcement, discipline, and investigations.
• Material & Department Audits
  • Audit starting and packing materials as per EU GMP and ICH guidelines.
  • Audit finished dosage forms as per cGMP, EU GMP, and ICH guidelines.
  • Audit the Pharmacovigilance department as per Good Pharmacovigilance Practices, EMA GVP, and ICH guidelines.

Ideal Profile:

A senior pharmaceutical quality/compliance professional with strong experience in corporate compliance, regulatory audits, QMS, data integrity and multi-site manufacturing operations, with the ability to independently assess risks and influence site leadership.