Senior Executive, CoE – Aseptic & Sterile Manufacturing Lead sterile-manufacturing excellence and strengthen contamination control across sites.

About the Role
Work with the Head of CoE to lead site CoE activities and drive consistent aseptic and sterile manufacturing practices across sites. You will provide technical leadership in sterility assurance, contamination control, risk management, and inspection readiness while building subject-matter expertise and supporting continuous improvement. Reporting to: Head, CoE – Aseptic & Sterile Manufacturing

Key Responsibilities
• Establish and harmonize aseptic manufacturing standards, including operator practices, interventions, contamination control strategies (CCS), and media fill governance.
• Lead site maturity assessments, identify sterility risks, and coordinate improvement plans with clear owners, milestones, and effectiveness checks.
• Provide technical review of critical deviations, investigations, and corrective and preventive actions (CAPAs); challenge unsupported risk acceptance and recurring failure modes.
• Support critical qualification activities, operational risk assessments, regulatory inspections, and closure of readiness gaps.
• Monitor sterile-manufacturing KPIs and trends, prioritize improvement initiatives, and ensure timely closure of CoE actions.
• Escalate critical sterility, contamination-control, patient-safety, data-integrity, and regulatory risks through established quality and management processes.
• Recommend proportionate controls or activity holds through approved site governance; final batch disposition and quality approvals remain with authorized functions.
• Coach subject-matter experts, lead technical forums and field coaching, and strengthen team capability and succession readiness.
• Collaborate with Manufacturing, Quality, Microbiology, Engineering, Validation, Regulatory Affairs, Projects, Digital, and Learning teams, and authorized external partners.



Qualifications and Experience
• Bachelor’s or master’s degree in pharmacy
• Typically, 12–15 years of experience in sterile pharmaceutical manufacturing, quality, sterility assurance, validation, microbiology, or engineering, including at least 3–5 years of team or cross-functional leadership.
• Strong technical knowledge of aseptic processing, barrier systems, CCS, media fills, environmental and personnel monitoring, sterilization and depyrogenation, sterile filtration and PUPSIT, cleaning and disinfection, airflow visualization, VHP, qualification, and process validation; terminal sterilization knowledge where applicable.
• Working knowledge of EU GMP Annex 1, FDA aseptic processing expectations, PIC/S GMP guidance, applicable pharmacopeial requirements, ICH Q9, and ICH Q10. Preferred Experience and Credentials
• Multi-site or corporate experience.
• Formal training or certification in quality risk management, Lean Six Sigma, project management, auditing, sterile manufacturing, microbiology, or validation. What You Bring
• Sound technical judgment and a risk-based approach to sterility assurance and patient safety.
• Structured investigation and problem-solving skills, with a focus on evidence and effective CAPAs.
• Ability to influence across sites, build cross-functional alignment, and communicate complex technical risks clearly.
• Solid execution discipline, data-driven decision-making, and accountability for action closure.
• A coaching mindset and commitment to developing technical expertise within teams. Work Environment and Travel This role combines corporate and manufacturing-site work, with regular cleanroom and technical-area presence. Cross-site travel is required based on risk and business priorities. Extended support may be needed during critical investigations, media fills, shutdowns, project qualification, or regulatory inspections. All work must follow applicable site safety, gowning, data-integrity, confidentiality, and quality-system requirements. Compensation
- up to 16 to 18 LPA

📌 Senior Executive (Indore)
🏢 LUPIN
📍 Indore