Corporate Quality & Compliance Lead

Quality Systems, Audit Readiness & Regulatory Compliance

Leumas · Bengaluru

We’re hiring a senior quality professional to build and operate the corporate quality and compliance backbone of next-generation manufacturing at Leumas.

This is a critical role responsible for designing, standardizing, and enforcing quality systems across development, manufacturing, and scale-up.

We’re looking for a high-ownership operator who understands regulated environments and can build systems that ensure:

• Audit readiness
• Compliance discipline
• Consistent product quality across programs

Company Overview — Leumas

Leumas is a venture-funded, Bangalore-based CRDMO building a next-generation manufacturing platform for wellness and pharmaceutical products.

We combine:

• Modular production systems (robotic micro factory)
• Software-defined manufacturing
• Integrated quality and traceability

To enable:

• Faster product launches
• Flexible scale (pilot → commercial)
• Reliable, audit-ready execution

As we scale across nutraceuticals and pharmaceutical programs, quality systems and compliance discipline become central to trust and growth.

The Role

You will build and own Leumas’ corporate quality and compliance system end-to-end:

SOPs → documentation → audits → CAPA → training → system governance

This is not a plant QA/QC role.

You will operate at the system level, ensuring that:

• Every process is defined
• Every deviation is tracked
• Every audit is handled with confidence

Your goal:

Ensure Leumas operates with audit-ready, scalable, and globally credible quality systems.

What You’ll Own

1. Quality Systems & SOP Framework

→ Build and standardize:

• SOPs across manufacturing, NPD, QC, and supply chain
• Documentation structures and templates
• Change control systems

→ Ensure:

• Process clarity and repeatability
• Alignment with GMP / FSSAI / pharma expectations

2. Audit Readiness & Compliance

→ Prepare and lead:

• FSSAI inspections
• Client audits (domestic & international)
• Future USFDA / global audits

→ Ensure:

• Documentation readiness at all times
• Zero last-minute firefighting

→ Build:

• Audit response frameworks
• Inspection readiness checklists

3. CAPA & Deviation Management

→ Design and enforce systems for:

• Deviation tracking
• Root cause analysis
• Corrective and preventive actions

→ Ensure:

• Issues are solved permanently, not temporarily
• Learnings are captured and reused

4. Documentation & Traceability Systems

→ Ensure:

• Batch documentation discipline (BMR/BPR)
• Material traceability
• QC documentation integrity

→ Work with internal systems (Leumasware) to:

• Digitize and standardize records
• Improve visibility and audit readiness

5. Training & Quality Culture

→ Build training systems for:

• GMP practices
• SOP adherence
• Documentation discipline

→ Ensure:

• Teams understand “why quality matters,” not just “what to do”

→ Drive a culture of:

• Ownership
• Accountability
• Compliance without shortcuts

6. Cross-Functional Quality Governance

→ Work closely with:

• Manufacturing (execution discipline)
• NPD (formulation & documentation)
• Supply Chain (material compliance)

→ Ensure:

• Quality is integrated into every function
• Not treated as a separate layer

You’re a Fit If

You bring 10–20+ years of experience in:

• Quality assurance / compliance
• Nutraceutical, pharmaceutical, food, or regulated manufacturing environments

You have:

• Strong experience with GMP systems and audit handling
• Exposure to FSSAI / pharma compliance frameworks
• Experience building or improving quality systems

You are:

• Structured and detail-oriented
• Comfortable enforcing discipline across teams
• Able to balance compliance with execution speed

Bonus (Preferred)

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

How You Will Operate

You are:

• A system builder, not just an auditor
• Firm on quality, but practical in execution

You:

• Prevent problems instead of reacting to them
• Build systems that scale, not patch issues repeatedly
• Maintain clarity without creating unnecessary bureaucracy

You work cross-functionally:

because quality is not a department — it is a system across the company

Why Join

This is a foundational role in building Leumas’ global credibility.

You will:

• Define how quality systems operate as we scale
• Build audit-ready systems for nutraceuticals and pharma
• Work closely with founders and leadership

As Leumas expands:

→ This role can evolve into Head of Corporate Quality / Global Quality Leadership