GM/DGM Quality Assurance (API)

BVR People Consulting; Chennai District; On-site; INR 4,500,000 - 7,500,000; Full time

Job summary

BVR People Consulting seeks a visionary GM/DGM of Quality Assurance to anchor an API manufacturing facility in Chennai. The role demands 25+ years of QA/QC leadership, with deep cGMP/GLP expertise and fluency in the local language.

The successful candidate will defend the site against major international audits, oversee master files and QA systems, and coordinate seamless technology transfers, ensuring compliant operations and robust quality governance.

Qualifications

• 25+ years of pharma/chemical manufacturing leadership experience.
• Deep exposure to cGMP/GLP regulatory environments.
• Proven track record defending audits by global health authorities.

Responsibilities

• Global Regulatory Defense: head facility audits by USFDA, EDQM, PMDA, KFDA, Cofepris, and CDSCO.
• Quality Systems Leadership: oversee SMF, VMP, DMF, and Quality Manual management.
• Operations & Document Control: manage OOS, OOT, CAPA, Deviations, and Change Control.
• Technology Transfer Coordination: orchestrate validated product transfers at scale.
• Corporate Integration: drive ISO 9001/14001/22000 and health-safety standards.
• Analytical & Lab Oversight: guide labs, stability studies, and analytics environments.

Skills

Quality Assurance

Quality Control

Regulatory Compliance

Leadership

Technology Transfer

Education

Ph.D. in Chemistry

Advanced Diploma in Pharmaceutical Quality Assurance Management

Job description

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.