Team Lead - Operation Excellence

Job Title : Team Lead – Operational Excellence (OE)

Function: Operations / Quality Systems / Continuous Improvement

Industry: Biopharmaceutical Development & Manufacturing (CDMO / CMO)

Experience: 15–20 years

Location: Shameerpet and Miyapur

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.

• 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

• Masters 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

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  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