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Tier-1 brand and Bangalore location increase competition, but senior regulated validation niche moderates applicant density.
Specialized regulated-industry validation and compliance skills limit transferability across unrelated industries.
Explicit 8+ years and mandatory regulated validation (21 CFR, ISO13485, GAMP5) make filters stringent.
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Implement and manage quality processes, policies, and procedures to ensure compliance and operational efficiency within the manufacturing and validation functions.
Oversee product inspection, supplier quality management, material qualification, and product recall activities ensuring adherence to regulatory and company standards.
Lead and mentor quality assurance teams, collaborating with cross-functional stakeholders to drive strategic quality initiatives and continuous improvement.
Bachelor's or Master's Degree in Quality Management, Supply Chain Management, Engineering, Science or equivalent.
8+ years experience in a regulated industry including validation of computer systems, systems security and control, with knowledge of 21 CFR, ISO 13485, and GAMP 5.
Experience with Quality Assurance, Quality Management Systems, CAPA methodologies, supplier quality management, and regulatory compliance.
Role requires onsite presence at company facilities (minimum 3 days/week in office-based setting).
Experienced quality leader comfortable managing operational frameworks and regulatory compliance in disciplined, regulated environments.
Strategic operator with proven skills in cross-functional collaboration, project team leadership, and continuous improvement methodologies.
Strong background in supplier and product quality management in regulated health technology or similar industry sectors.