Role Overview: We are seeking a seasoned Quality Assurance leader to spearhead the QA function at our manufacturing site. The role involves driving compliance with global regulatory standards, strengthening Quality Management Systems (QMS), and ensuring product quality and patient safety across the lifecycle. The incumbent will act as the independent quality authority, embedding quality governance into all business decisions and enabling organizational growth through continuous improvement.

Key Responsibilities:
Define and implement the organizations quality vision, strategy, and governance framework.
Provide strategic oversight for QMS including Change Control, Deviations, CAPA, Risk Management, Document Control, Training, Complaints, and Product Release.
Lead proactive quality risk management initiatives across operations and supply chain.
Ensure product quality, safety, and compliance throughout lifecycle management, validation, and technology transfers.
Drive inspection readiness and lead responses to regulatory audits and customer inspections.
Establish supplier quality programs, ensuring qualification, monitoring,



and auditing of external partners.
Build and mentor a high-performing QA team, fostering a culture of compliance, integrity, and continuous improvement.
Partner cross-functionally with Manufacturing, QC, Regulatory Affairs, R&D;, Supply Chain, and Engineering to support business expansion and recent product introductions.

Candidate Profile:
Masters/Ph.D. in Biotechnology, Microbiology, Pharmacy, Life Sciences, or related discipline.
18+ years of experience in Quality Assurance within Biotechnology, Biopharmaceuticals, Vaccines, or Pharmaceuticals.
Minimum 8 years in senior leadership roles managing QA and compliance functions.
Robust expertise in cGMP, GLP, GDP, QMS, risk management, validation, data integrity, and regulatory inspections.
Proven track record of leading global regulatory audits and driving quality transformation initiatives.
Excellent leadership, stakeholder management, and communication skills.
Relevant certifications in Quality Management, Lead Auditor, or Six Sigma preferred.

📌 Head Quality Assurance Bengaluru (India)
🏢 Uberlife Consulting
📍 India