GM/DGM Quality Assurance (API)

Position Overview
We are seeking a visionary, executive-level GM/DGM of Quality Assurance to anchor operations at our high-compliance API manufacturing facility in Chennai. The ideal candidate will possess over 25 years of extensive industry experience spanning Quality Assurance, Quality Control, and complex technical transfers.
This leader will be fully accountable for upholding robust international quality systems (cGMP/GLP), defending the facility against stringent global health authority inspections, and managing localized operational dynamics through absolute fluency in local language.
Key Responsibilities

• Global Regulatory Defense: Directly head and defend the facility against critical international audits including USFDA (tracking historical success cycles), EDQM, PMDA (Japan), KFDA (Korea), Cofepris (Mexico), and national bodies like CDSCO.
• Quality Systems Leadership: Maintain supreme oversight of Site Master Files (SMF), Validation Master Plans (VMP), Drug Master Files (DMF), and overall Quality Manual management.
• Operations & Document Control: Oversee cross-functional investigation matrices involving Out of Specification (OOS), Out of Trend (OOT), Corrective and Preventive Actions (CAPA), Deviations, and Change Control tracking.
• Technology Transfer Coordination: Strategically orchestrate seamless product tech transfers from sending to receiving units, ensuring fully validated protocols are deployed smoothly at scale.
• Corporate Integration & Management: Serve as the chief Management Representative for key structural certifications, integrating corporate parameters like ISO 9001, ISO 14001, ISO 22000, and standard industrial health-safety rules.
• Analytical & Lab Oversight: Guide technical troubleshooting across analytical research labs, stability studies (per ICH guidelines), microbial processing units, and high-end wet analysis environments.

Candidate Profile & Custom Qualifications
Educational Requirements:

• Ph.D. in Chemistry (Highly preferred) or advanced post-graduate qualification in allied scientific disciplines.
• Supplemental certification like an Advanced Diploma in Pharmaceutical Quality Assurance Management will be highly valued.

Proven Track Record & Competencies:

• 25+ years of hardcore experience within Pharma/Chemical manufacturing settings, with a demonstrable trajectory climbing to senior leadership titles (e.g., General Manager / Head QA).
• Concrete experience defending against at least 3 cycles of USFDA audits along with broader multi-government regulatory exposures.
• Deep technical comfort managing analytical lab procurement, QC budget mapping, and localized manpower scheduling.

Interested Candidates Apply to

[email protected]