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.