Quality Manager

Responsibilities

• Lead and manage the organization's Quality Management System (QMS).
• Ensure compliance with FDA, cGMP, ISO 9001, ISO 13485, ICH, and applicable regulatory requirements.
• Oversee Quality Assurance (QA) and Quality Control (QC) operations.
• Develop, review, and approve Standard Operating Procedures (SOPs), quality procedures, and controlled documents.
• Manage deviations, investigations, Corrective and Preventative Actions (CAPAs), change controls, and Non-Conformance Reports (NCRs).
• Lead internal, supplier, customer, and regulatory audits and inspections.
• Ensure effective complaint handling, root cause analysis, and corrective/preventive actions.
• Monitor quality metrics and prepare management review reports.
• Support product development, technology transfer, process validation, and qualification activities.
• Manage supplier qualification and vendor audits.
• Collaborate with Manufacturing, Engineering, Validation, Regulatory Affairs, R&D, and Supply Chain teams.
• Lead risk assessments using Failure Modes and Effects Analysis (FMEA) and other quality risk management tools.
• Drive continuous improvement initiatives using Lean, Six Sigma, and Kaizen methodologies.
• Mentor and develop QA/QC personnel while fostering a quality-focused culture.

Requirements

• Bachelor's or Master's degree in Pharmacy, Biotechnology, Chemistry, Microbiology, Life Sciences, Engineering, or a related field.
• 8+ years of Quality Assurance and/or Quality Control experience in a regulated industry.
• Previous experience in a leadership or management role.
• Strong understanding of Quality Management Systems and regulatory compliance.