Quality Site Director
Position: Director of Site Quality
Location: Devon (On-site)
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.
FAQs
Congratulations, we understand that taking the time to apply is a big step. When you apply, your details go directly to the consultant who is sourcing talent. Due to demand, we may not get back to all applicants that have applied. However, we always keep your CV and details on file so when we see similar roles or see skillsets that drive growth in organisations, we will always reach out to discuss opportunities.
Yes. Even if this role isn’t a perfect match, applying allows us to understand your expertise and ambitions, ensuring you're on our radar for the right opportunity when it arises.
We also work in several ways, firstly we advertise our roles available on our site, however, often due to confidentiality we may not post all. We also work with clients who are more focused on skills and understanding what is required to future-proof their business.
That's why we recommend registering your CV so you can be considered for roles that have yet to be created.
Yes, we help with CV and interview preparation. From customised support on how to optimise your CV to interview preparation and compensation negotiations, we advocate for you throughout your next career move.