Site Head of Quality

At Guerbet, we build lasting relationships so that we enable people to live better.

We are a global leader in medical imaging, offering an extensive portfolio of pharmaceuticals, medical devices, as well as digital and AI solutions for diagnostic and interventional imaging. As a pioneer in contrast products for the last 95 years, we continuously innovate.

Customer centricity, Cooperation, Audacity,Focus, and Responsibilityare the values that we share and practice.

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The Site Head of Quality has the primary responsibility for overseeing the Quality Operations for commercial manufacturing and packaging for sterile, commercial dosage products. This position will focus on the development and continuous improvement of systems to ensure compliance to CGMP’s that meet company goals and the expectations of the markets in which Guerbet commercializes products. The Site Head of Quality will ensure a culture of compliance throughout the manufacturing, testing, packaging, and warehouse areas.

Responsible for overseeing Quality Assurance and Quality Control operations at Guerbet Raleigh.

Responsible for establishing a Quality Culture aligned with CGMPs and Guerbet Global standards.

Ensure Quality Systems are robust and continuously improved.

Responsible for ensuring that QA and QC teams (e.g., Quality Systems, Quality Operations, Microbiology) are properly staffed and trained to support compliant manufacturing operations.

Ensure quality system’s performance indicators (leading and lagging) are identified, monitored, and communicated to site leadership and Corporate Quality to ensure actions (corrective and preventive) are implemented.

Partner with the Site Lead Team to drive the mission and vision for the site.

Serve as the site liaison for Corporate Quality matters, actively engaging in cross-site quality forums and global QA leadership meetings.

Participate in corporate quality improvement projects and strategic programs, sharing best practices, and lessons learned to enhance group-wide quality performance.

Establish clear quality goals and objectives that align with organizational goals.

Ensure the site is always ready for inspections and audits.

Lead, coach, and mentor the Quality organization.

Model the behavior of “doing the right thing, even when no one is looking” on issues of quality.

Point person for regulatory agency inspections, communications, and any action because of these.

Identify and elevate critical quality issues proactively, ensuring timely communication and resolution of escalated matters with Corporate QA.

Ensure CGMP documents are current and meet applicable regulatory agency requirements, and Guerbet Global policies.

Ensure QA and QC personnel have approved job description and that performance management procedures are followed.

Coaching and mentorship skills.

Perform other duties as assigned by management.

Required:

• Bachelor or Master (preferred) in biology, chemistry, microbiology, engineering with 12-15 years of progressive leadership experience in sterile pharmaceutical manufacturing.
• Minimum of 7 years in QA or QC leadership role, preferably in both.
• Strong knowledge of regulatory authority requirements (US FDA, ANVISA, MFDS, EMA).
• Expert in CGMP’s with a proven track record for providing practical and effective solutions to address issues.
• Experience in direct interaction with FDA personnel during inspections.
• Excellent written and verbal communication skills.
• Highly motivated leader that works transversally to achieve results.
• Able to work under pressure and make data-driven decisions.
• Able to teach, guide, and influence others while inclusive and respectful.

• Experience in finance, supply chain, Operational Excellence, and HSE.
• 3-5 years of experience in sterile manufacturing.

Has strong attention to detail and organizational skill.

Committed and engaged in making high-quality products and expects the same from others.

Interpersonal skills to develop and mentor a…