Aurigene - Director - Operational Excellence

Role Overview

We are seeking a seasoned Operational Excellence (OE) leader to drive operational efficiency, quality, and GMP compliance across our biopharmaceutical development and manufacturing operations. This role will be responsible for embedding OE, compliance-by-design, and continuous improvement practices across the organization to improve right-first-time performance, regulatory readiness, and cost efficiency.

The role requires a strong blend of operations, quality, compliance, and change leadership within a regulated biopharma environment.

Experience: 15-20 years

Key Responsibilities

- Define and deploy an Operational Excellence roadmap aligned with business goals and regulatory expectations (US FDA, EMA, CDSCO).

- Integrate OE tools with GMP compliance and quality systems (ICH Q8/Q9/Q10, Data Integrity, CCS, CAPA).

- Drive continuous improvement initiatives to reduce deviations, batch failures, cycle time, waste, and cost of poor quality.

- Apply Lean, Six Sigma, and structured problem-solving tools (DMAIC, FMEA, VSM, Kaizen, RCA).

- Establish and monitor operational and quality KPIs (RFT, OTIF, deviation trends, audit metrics).

- Support regulatory inspections and customer audits through process standardization and operational maturity.

- Act as a change leader, embedding an OE and quality culture across manufacturing, quality, MSAT, and supply chain teams.

- Coach and mentor teams on structured problem-solving and GMP discipline.

Education

- Master's degree in chemical engineering, Biotechnology, Biochemical / Pharmaceutical Sciences, or equivalent. With 12-15 years of industrial experience in a quality organization and an Operations Excellence role (> 3 years)

- MBA (Operations / Quality / Strategy) - preferred.

Certifications (Highly Preferred)

- Lean Six Sigma Black Belt / Master Black Belt

- Total Quality Management (TQM)

- ASQ (CQE, CQA, CSSBB) or equivalent certifications

- Project Management (PMP) - desirable

Key Skills & Competencies

- Strong knowledge of GMP regulations and quality systems

- Expertise in Lean, Six Sigma, and OE frameworks

- Data-driven decision-making and statistical analysis

- Ability to influence cross-functional stakeholders

- Strategic mindset with hands-on execution ability

- Strong communication and leadership skills

Why Join Us

- Opportunity to drive enterprise-wide transformation in a growing Biologics CDMO organization

- High-impact role with direct visibility to senior leadership and global clients

- Platform to build a world-class operational and compliance culture