Job Title: Site Quality Head
📍 Location: Bangalore, Karnataka, India
💼 Job Type: Full-time
🆔 Job ID: 292178
About the Company
We are a global organization innovating across Healthcare, Life Science, and Electronics to improve lives. Our teams operate worldwide, fostering a culture of curiosity, inclusion, and collaboration.
Role Overview
The Site Quality Head is responsible for leading the strategic direction of quality management at the manufacturing site. This role ensures all products meet the highest quality standards, safeguards patient safety, and maintains compliance with regulatory requirements. By fostering a culture of continuous improvement, the position enhances operational efficiency and drives the company’s growth and reputation in the pharmaceutical industry.
Key Responsibilities
Lead and manage Quality Assurance (QA) and Quality Control (QC) teams, ensuring effective quality systems implementation.
Develop, implement, and maintain quality policies and procedures in compliance with cGMP and regulatory standards.
Monitor and ensure adherence to quality standards throughout the manufacturing process.
Conduct audits and inspections of processes, facilities, and systems for regulatory compliance.
Collaborate with cross-functional teams (Manufacturing, Regulatory Affairs, R&D) to address quality issues.
Manage investigations, root cause analyses, and implement corrective and preventive actions for deviations, non-conformances, and complaints.
Prepare and present quality metrics and reports to senior management.
Stay updated on industry trends and regulatory changes to maintain effective and compliant quality systems.
Lead quality improvement initiatives, technology transfers, change control, qualification & validation, and regulatory compliance activities.
Qualifications & Experience
Education: Bachelor’s in Engineering (Mechanical/Electrical/Chemical/Biotechnology) or Master’s in Microbiology.
Experience: ~20 years in Quality, including at least 3 years as Head of Site Quality in reputed pharmaceutical manufacturing organizations (preferably MNCs).
Regulatory Knowledge: In-depth knowledge of cGMP, FDA, EU GMP, ICH, ISPE, PICs, DOE, SQC.
Technical Skills: FMEA, Change Control, Stability Study, Qualification & Validation, Cleanroom requirements, Environmental Monitoring, AHU systems.
Leadership Skills: Strong communication, proactive decision-making, team player, customer-focused mindset.
Other Skills: Analytical and problem-solving skills, ability to influence across all levels of the organization.
What We Offer
A diverse and collaborative global work environment.
Opportunities for personal and professional growth.
A culture of inclusion, continuous improvement, and innovation.
The ability to make meaningful contributions to operational excellence and human progress.
🔗 Apply Now to join a team dedicated to innovation, quality excellence, and driving impact in the pharmaceutical industry.
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