Senior Quality Head Nutraceuticals
2 weeks ago
Location:
Harohalli Plant, Bengaluru
Experience:
12–18 years in Quality leadership roles within Pharma / Nutraceuticals / Cosmetics / CDMO / Manufacturing
Reports to:
Founders (CEO/CTO)
Key Responsibilities:
• Quality Strategy & Leadership
• Define and implement a comprehensive Quality Management System (QMS) across all production lines and facilities.
• Lead the QA & QC functions (in-process, finished goods, packaging, documentation).
• Drive regulatory readiness for India and global markets (USFDA, EMA, TGA).
• Champion a quality-first culture aligned with Leumas' mission of robotic precision and on-demand manufacturing.
• Compliance & Regulatory
• Ensure compliance with FSSAI, AYUSH, CDSCO, USFDA, ISO 22000, HACCP, GMP.
• Lead inspections, audits, and certifications.
• Develop SOPs for all critical operations; ensure documentation is digitized and traceable in Leumasware.
• Stay ahead of evolving global regulations and guide management on compliance strategy.
• Operations & Execution
• Oversee QC labs, equipment validation, and method development.
• Set standards for raw material, in-process, and finished product testing.
• Collaborate with NPD to define QC parameters during formulation development.
• Drive continuous improvements in batch release timelines, stability programs, and CAPA.
• Team Development
• Build and mentor a high-performance QA/QC team (managers, analysts, technicians).
• Foster accountability, training, and cross-functional alignment.
• Introduce best-in-class tools and digital systems to automate compliance tracking.
• Client & Stakeholder Engagement
• Act as a quality ambassador with clients, ensuring trust in Leumas' products.
• Support BD and Service Delivery teams in quality-related client interactions.
• Provide strategic inputs for dedicated factory clients and global expansion.
Desired Candidate Profile:
• Educational Qualification: M. Pharm / M.Sc (Chemistry, Biotech, Life Sciences) with a strong regulatory background.
• Proven track record of leading QA/QC in Pharma, Nutraceuticals, or Cosmetics, preferably in a CDMO/contract manufacturing setup.
• Strong knowledge of Indian and International regulatory frameworks.
• Experience handling regulatory audits and client inspections.
• Leadership ability to scale teams and systems in a fast-growing, high-intensity startup environment.
• Excellent communication, documentation, and cross-functional collaboration skills.
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