Quality Site Director

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Overview: As the Director of Site Quality, you will work closely with cross-functional leaders and team members to ensure the effective implementation, monitoring, and continuous enhancement of the Quality Management System (QMS) in accordance with certification standards and customer requirements.

Reporting Line: This role reports to the Senior Director of QA

Key Responsibilities:

• Quality Leadership & Compliance: Act as the Quality Management Representative for the site, leading QA/QC functions, ensuring regulatory compliance, and aligning with the company\’s quality objectives.
• Quality Management System (QMS): Implement, maintain, and enhance the QMS, ensuring that procedures, work instructions, and IT systems support site operations, and promote a culture of continuous improvement.
• Strategic Partnership & Advocacy: Collaborate with site and global leadership to manage process changes, advocate for site-specific needs, and drive customer-focused solutions during change management initiatives.
• Team Development & Performance: Develop a high-performing quality department, fostering a safe and empowering environment that encourages skill development, psychological safety, and continuous improvement.
• Audits, Reporting, & Representation: Lead Quality Management Reviews, define and monitor key performance indicators (KPIs), host audits, and represent the site in executive discussions and global best practice initiatives.

Qualifications:

• Educational Background: Bachelor\’s degree in Science, Business, Engineering, or a related field.
• Experience: Minimum of 7 years of experience in Quality Assurance, Quality Engineering, or Manufacturing Operations within Life Sciences, Biotechnology, Medical Device, Biopharma, or other FDA/EPA-regulated manufacturing environments.
• Leadership Experience: Several years of leadership experience, with senior roles in QA, Operations, or Quality Engineering preferred.
• Regulatory and Quality Expertise: Strong knowledge of ISO standards, FDA regulations, cGMPs, CFR requirements, and quality management practices, including operational controls, CAPA, complaints, audits, and risk management.
• Analytical and Process Optimization: Proficiency in quality statistical methods, Lean Manufacturing principles, Six Sigma methodologies, and Root Cause Analysis tools to drive data-driven decisions and resource optimization.
• Leadership and Communication: Proven ability to lead, coach, and mentor teams; manage performance; plan succession; and effectively communicate at all organizational levels, both written and verbal.
• Strategic and Operational Acumen: Skilled in managing budgets, assessing opportunity costs, and fostering innovative problem-solving, while maintaining exceptional organizational and time management capabilities.

Travel Requirements:

• Ability to travel up to 10% of the time to other manufacturing locations in Europe and worldwide, as required.

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