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.
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
