Manager - Corporate Harmonization (Quality Systems)

Glenmark Pharmaceuticals · India

We are specifically seeking professionals with strong Quality Assurance experience in OSD Manufacturing Quality Systems, Quality Compliance, Site Quality Operations, and Corporate Quality Harmonization, including hands-on exposure to QMS processes, regulatory compliance, investigations, validation, batch record review, quality system governance, and regulatory inspections.

About the Role

Develop, review, and harmonize Corporate GSOPs, Policies, and Procedures. Collaborate with Site SPOCs and cross-functional teams to ensure consistent execution of quality processes. Verify alignment of Global GSOP requirements with site-level practices and drive closure of identified gaps. Support quality remediation, compliance improvement, and inspection readiness initiatives. Travel 25–35% across sites to support harmonization activities, process verification, and stakeholder engagement.

Responsibilities

• Develop, review, and harmonize Corporate GSOPs, Policies, and Procedures.
• Collaborate with Site SPOCs and cross-functional teams to ensure consistent execution of quality processes.
• Verify alignment of Global GSOP requirements with site-level practices and drive closure of identified gaps.
• Support quality remediation, compliance improvement, and inspection readiness initiatives.
• Travel 25–35% across sites to support harmonization activities, process verification, and stakeholder engagement.

Qualifications & Experience:

• B.Pharm / M.Pharm
• Experience: 8–15 Years
• Strong hands-on experience in Quality Management Systems (QMS).
• Experience working in pharmaceutical manufacturing sites subject to regulatory inspections

Required Skills

• Excellent verbal and written communication skills in English.
• Strong technical writing and review skills for GSOPs, Policies, and Procedures.
• Effective stakeholder management and ability to work with multiple manufacturing sites.
• Strong analytical, review, and problem-solving skills.
• Strong understanding of global regulatory expectations and quality compliance requirements across pharmaceutical manufacturing operations.

Preferred Skills

• Hands-on exposure to regulatory inspections, audits, and compliance requirements of agencies such as US FDA, MHRA, EU GMP, WHO GMP, and other global regulatory authorities.
• Experience in remediation and compliance improvement programs.