THE OPPORTUNITY:

Under limited direction, direct the activities for the quality organization for their respective facility. Manage, organize, oversee and ensure the objectives of the QA/QC function are implemented in line with Corporate, site quality and business goals. Develop, manage, and maintain the quality management system to meet applicable regulatory requirements (FDA CFRs, U.S, and international regulations) and international quality standards; ensure products meet customer quality expectations and requirements. Develop, monitor and manage approved departmental budget. Ensure timely closure of all non-conformances, failure investigation reports and corrective/preventive actions; develop strategies for continuous improvement

EXPERIENCE:

• 5+ years of experience in regulated industry with leadership experience in change control or quality management – preferably in chemical manufacturing or bioprocessing
• Deep understanding of ICH, FDA, EMA, and ISO requirements
• Proven ability to lead cross-functional teams and influence across levels
• Excellent communication, analytical, and decision-making skills
• Proficiency in QMS software and data analytics
• Working knowledge of GMP and regulatory requirements

PREFERRED QUALIFICATIONS:

• Ability to interact with and gain buy-in from senior leadership.
• Proficiency in Microsoft Outlook, Word, Excel, PowerPoint, Visio, Teams, and chromatography/LIMS software. SAP experience is an asset.
• Excellent communication skills, both written and verbal.
• Strong time management and prioritization skills.
• Ability to liaise with different departments to ensure software compliance with regulatory requirements.
• Self-motivated to drive global lab modernization projects and improvements.

Please refer the Job description for details