Manager - Internal Audit & Compliance

Job Summary: We are looking for an experienced quality professional to join the Corporate Quality Audits team as Manager – Internal Quality Audit. The role will be responsible for conducting and managing internal quality audits across manufacturing and quality systems with a strong focus on Quality Control operations, regulatory compliance, and continuous quality improvement across formulation sites. The ideal candidate should possess strong pharmaceutical Quality Control knowledge, hands-on experience with OOS investigations, familiarity with regulatory expectations, and experience in formulation manufacturing environments (OSD preferred).

Prior experience in corporate/internal quality audits will be an added advantage. Key Responsibilities Conduct internal quality audits across manufacturing sites, Quality Control laboratories, warehouses, and quality systems. Perform detailed assessment of Quality Control systems, laboratory practices, data integrity, documentation practices, and compliance adherence.

Review and evaluate: OOS/OOT investigations, Laboratory deviations and CAPA effectiveness, Analytical method compliance, Data integrity practices, change controls and risk assessments Assess compliance with global regulatory requirements, including US FDA, MHRA, EU GMP, WHO, PIC/S, and other applicable guidelines. Identify compliance gaps, quality risks, and recommend remediation actions. Prepare audit reports and support the closure of audit observations by effectively tracking CAPAs.

Monitor current regulatory trends and ensure audit practices remain aligned with evolving expectations. Support audit readiness initiatives and continuous improvement programs across sites. Collaborate with cross-functional teams, including QA, QC, Manufacturing, Regulatory Affairs, and Corporate Quality.

Travel extensively across manufacturing locations to conduct audits and compliance assessments. Desired Candidate Profile Bachelor’s / master’s degree in pharmacy, Chemistry, Pharmaceutical Sciences, or related discipline. 12–15 years of experience in pharmaceutical Quality Control / Quality Assurance with strong exposure to formulation manufacturing. Strong background in Quality Control operations and laboratory compliance.

Hands-on experience in: OOS investigations Laboratory systems and documentation Regulatory compliance and inspection readiness GMP and Data Integrity practices Experience in Oral Solid Dosage (OSD) / formulation manufacturing is preferred. Candidates currently working in Corporate/Internal Quality Audits will be preferred. Exposure to regulatory inspections such as the US FDA, MHRA, EU, WHO, or similar agencies is highly desirable.

Good understanding of current regulatory expectations and global GMP guidelines. Strong audit, communication, analytical, and report-writing skills. Willingness to travel extensively (60–70%).