Assembly & Packaging Lead / Manager

Responsibilities

• Lead startup, commissioning, qualification, validation, and operational readiness for Assembly, Visual Inspection, and Packaging operations.
• Provide technical and operational leadership to ensure safe, compliant, and efficient manufacturing execution.
• Oversee equipment lifecycle management, including qualification, validation, maintenance, troubleshooting, and continuous improvement.
• Drive visual inspection programs, defect management, POD studies, QRA assessments, and process optimization.
• Lead engineering runs, media fills, process validation, PPQ, and commercial manufacturing activities.
• Collaborate with cross-functional teams to support NPI, technology transfer, process improvements and product lifecycle management.
• Ensure compliance with cGMP, FDA, EMA, PIC/S, ICH, Annex 1, and customer requirements while maintaining inspection readiness.
• Lead investigations, deviations, CAPAs, risk assessments, and Change Controls to ensure product quality and compliance.
• Drive operational excellence through performance monitoring, productivity improvements, quality enhancement, and cost optimization.
• Review and approve GMP documentation, including SOPs, batch records, protocols, reports, and training materials.
• Oversee QMS activities, audits, inspections, data integrity, and regulatory commitments.
• Manage department resources, project timelines, and production priorities to meet business objectives.
• Serve as a key contact for customers, auditors, and regulatory authorities.
• Coach and develop teams while promoting a culture of safety, quality, compliance, and continuous improvement.
• Provide leadership during critical manufacturing operations, validation campaigns, and regulatory inspections.
• Accountable for overall operational, technical, quality, compliance, and business performance.

Requirements

• Bachelor's degree in Pharmaceutical Sciences, Chemical Engineering or related field
• 5+ years of experience in drug product manufacturing
• Extensive experience in pharmaceutical manufacturing, particularly visual inspection and packaging operations.
• Strong knowledge of cGMP and global regulatory requirements,
• Strong technical, analytical, troubleshooting, root cause investigation, and decision-making skills.