Job Title

Job Title : Team Lead – Operational Excellence (OE) Function: Operations / Quality Systems / Continuous ImprovementIndustry: Biopharmaceutical Development & Manufacturing (CDMO / CMO)Experience: 15–20 yearsLocation: Shameerpet and MiyapurRole OverviewWe 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 ResponsibilitiesDefine 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.EducationMaster’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 BeltTotal Quality Management (TQM)ASQ (CQE, CQA, CSSBB) or equivalent certificationsProject Management (PMP)– desirableKey Skills & CompetenciesStrong knowledge of GMP regulations and quality systemsExpertise in Lean, Six Sigma, and OE frameworksData-driven decision-making and statistical analysisAbility to influence cross-functional stakeholdersStrategic mindset with hands-on execution abilityStrong communication and leadership skillsWhy Join UsOpportunity to drive enterprise-wide transformation in a growing Biologics CDMO organizationHigh-impact role with direct visibility to senior leadership and global clientsPlatform to build a world-class operational and compliance culture