Quality Site Director

JR United Kingdom; England; On-site; GBP 60,000 - 100,000; Full time

Job summary

An established industry player is seeking a Director of Site Quality to lead quality initiatives and ensure compliance with certification standards. In this pivotal role, you will collaborate with cross-functional teams to implement and enhance the Quality Management System, advocate for site-specific needs, and drive continuous improvement. Your leadership will foster a high-performing quality department, ensuring adherence to regulatory standards and promoting a culture of excellence. If you're passionate about quality and looking to make a significant impact in a dynamic environment, this is the opportunity for you.

Qualifications

• Minimum 7 years of experience in Quality Assurance or Manufacturing Operations.
• Strong knowledge of ISO standards and FDA regulations.

Responsibilities

• Lead QA/QC functions and ensure regulatory compliance.
• Implement and enhance the Quality Management System.

Skills

Quality Assurance

Quality Engineering

Leadership

Regulatory Compliance

Analytical Skills

Lean Manufacturing

Six Sigma

Education

Bachelor's degree in Science, Business, Engineering

Tools

Root Cause Analysis tools

Job description

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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.