Corporate Quality & Compliance Lead

About Leumas

Leumas is a venture‑funded, Bangalore‑based CRDMO building a next‑generation manufacturing platform for wellness and pharmaceutical products. The company combines modular production systems (robotic micro‑factory), software‑defined manufacturing, and integrated quality and traceability to enable faster product launches, flexible scale (pilot → commercial), and reliable, audit‑ready execution.

Role Overview

The Corporate Quality & Compliance Lead will design, standardize, and enforce quality systems across development, manufacturing, and scale‑up. This senior, high‑ownership role focuses on audit readiness, compliance discipline, and consistent product quality across programs. It is a system‑level position—not a plant QA/QC role.

Responsibilities

• Quality Systems & SOP Framework

  • Build and standardize SOPs across manufacturing, NPD, QC, and supply chain.
  • Create documentation structures, templates, and change‑control systems.
  • Ensure process clarity, repeatability, and alignment with GMP/FSSAI/pharma expectations.

• Audit Readiness & Compliance

  • Prepare for and lead FSSAI inspections, client audits (domestic & international), and future USFDA/global audits.
  • Maintain documentation readiness at all times; eliminate last‑minute firefighting.
  • Develop audit response frameworks and inspection‑readiness checklists.

• CAPA & Deviation Management

  • Design and enforce systems for deviation tracking, root‑cause analysis, and corrective & preventive actions.
  • Ensure issues are solved permanently and learnings are captured and reused.

• Documentation & Traceability Systems

  • Enforce batch documentation discipline (BMR/BPR), material traceability, and QC documentation integrity.
  • Work with internal systems (Leumasware) to digitize and standardize records, improving visibility and audit readiness.

• Training & Quality Culture

  • Build training programs for GMP practices, SOP adherence, and documentation discipline.
  • Promote a culture of ownership, accountability, and compliance without shortcuts.

• Cross‑Functional Quality Governance

  • Collaborate with Manufacturing, NPD, and Supply Chain to integrate quality into every function.
  • Ensure quality is not treated as a separate layer but as a company‑wide system.

• Operational Mindset

  • Prevent problems rather than react to them.
  • Build scalable systems instead of patching issues repeatedly.
  • Maintain clarity without creating unnecessary bureaucracy.

Requirements

• 10–20+ years of experience in quality assurance/compliance within nutraceutical, pharmaceutical, food, or other regulated manufacturing environments.
• Strong experience with GMP systems and audit handling.
• Exposure to FSSAI and pharma compliance frameworks.
• Proven track record building or improving quality systems.
• Structured, detail‑oriented, and comfortable enforcing discipline across teams.
• Ability to balance compliance with execution speed.

Preferred Qualifications (Bonus)

• Experience with USFDA or other global audits.
• Background in CDMO/CRDMO environments.
• Exposure to digital quality systems.
• Strong understanding of documentation systems (BMR, COA, etc.).

Why Join

• Foundational role shaping Leumas’ global credibility and quality infrastructure.
• Opportunity to define how quality systems operate as the company scales.
• Direct collaboration with founders and senior leadership.
• Potential career growth into Head of Corporate Quality or Global Quality Leadership as Leumas expands.