QC Laboratory Manager

Our client is a global injectables company headquartered in Bengaluru, India, with a strong presence across Asia, Europe, and the USA, and is expanding rapidly into new markets. The company focuses on developing value-added sterile injectables that address critical gaps in healthcare delivery.

By enhancing hospital workflows, reducing wastage of key resources, and improving operational efficiency, our client plays a vital role in supporting healthcare professionals. A robust and reliable supply chain further ensures consistent access to essential medications for patients worldwide.

Responsibilities:

• Establish and lead the QC laboratory, including analytical and microbiological functions, supporting sterile injectable IV bag production.
• Oversee all testing activities: raw material, in-process, finished product, and stability testing, in compliance with applicable cGMP and regulatory requirements.
• Support and manage startup, qualification, calibration, and maintenance of all QC lab equipment and systems to ensure operational readiness and regulatory compliance.
• Develop and enforce strong data integrity practices, including procedures, training, and routine monitoring of laboratory systems and documentation.
• Build and maintain a scientifically sound, compliant laboratory environment capable of supporting high-potent APIs and controlled substances.
• Hire, train, and mentor laboratory personnel to ensure technical capability and compliance with laboratory and safety procedures.
• Implement and maintain robust systems for documentation (SOPs, protocols, specifications), investigations (OOS, deviations), and CAPA management.
• Lead and support analytical method transfers, validations, and technical investigations in collaboration with cross-functional teams.
• Oversee microbiology operations, including environmental monitoring, utility sampling, sterility testing, and microbiological release activities.
• Ensure inspection readiness and represent QC in audits, PAIs, and regulatory inspections.
• Collaborate cross-functionally with QA, Validation, Engineering, Manufacturing, and Regulatory to ensure alignment and compliance across the site.
• Ensure adherence to safety protocols, especially in handling high-potent materials and controlled substances.
• Establish laboratory KPIs and drive continuous improvement in performance, compliance, and operational efficiency.

Requrements:

Qualifications / Experience:

• Bachelor’s or Master’s degree in Chemistry, Microbiology, or related scientific discipline.
• 8–12 years of pharmaceutical QC laboratory experience, including 3–5 years in a leadership role.
• Experience with sterile injectable manufacturing, high-potent APIs, and controlled substances is required.
• Deep knowledge of cGMP, FDA, ICH, USP, and applicable global regulatory standards.
• Experience with startup or greenfield sites and laboratory buildouts preferred.
• Demonstrated experience with method transfer, validation, and technical problem-solving.
• Experience establishing equipment lifecycle programs, including qualification and maintenance.

Skills / Competencies:

• Strong leadership with ability to build and develop high-performing lab teams.
• Excellent technical knowledge in analytical and microbiological testing.
• Deep understanding of data integrity principles and enforcement of best practices.
• Proficiency in laboratory systems (LIMS, CDS, ELN) and equipment qualification.
• Ability to manage complex lab operations in a startup environment.
• Strong project management, documentation, and communication skills.
• Commitment to patient safety, quality, and regulatory compliance.