Senior Quality Manager

Job purpose

Reporting to the Director, Quality Operations EU/RoW (Molecular Imaging Platform), the Senior Manager Quality Operations, EU/RoW will be responsible for managing the quality operations of Blue Earth Diagnostics’ EU/RoW based third-party Contract Manufacturing Organisation (CMO) network and oversight of the supply chain. This includes ensuring that medicinal products supplied by the company are manufactured, released and distributed in compliance with UK, EU and RoW applicable laws and regulations. The position requires operational oversight and cross-functional collaboration to maintain a robust and consistent supply of quality products in accordance with regulatory requirements.

Main Responsibilities, Activities, Duties and Tasks

• Serve as the primary quality point of contact for EU/ RoW -based Contract Manufacturing Organizations (CMOs), overseeing manufacturing performance, resolution of quality-related issues and managing quality relationships with CMOs.
• Qualify new CMOs and perform periodic requalification according to Blue Earth Diagnostics (BED) procedures.
• Maintain and manage the risk-based audit schedule.
• Ensure appropriate documentation and maintenance of quality oversight records, including routine monitoring and follow-up actions.
• Manage and oversee CMO investigation reports, including analytical Out of Specifications, to ensure technical accuracy, regulatory compliance, and effective root cause analysis.
• Lead routine quality meetings with CMOs to manage performance, deviations, complaints, changes, improvements, and escalations.
• Gather data and perform trending and analysis of CMO performance and quality to proactively identify risks and drive continuous performance improvement.
• Conduct scheduled on-site CMO audits in accordance with the annual audit schedule and manage approved contract auditors as applicable.
• Work in accordance with quality risk management principles.
• Support the continuous enhancement of the Blue Earth Diagnostics Quality Management System (QMS), including SOP revisions, process optimization, and alignment with global standards.
• Contribute to the development and presentation of Quality Assurance metrics and reports for Quality Management Review (QMR).
• Monitor regulatory changes related to EU PET and pharmaceutical manufacturing, quality, and distribution; evaluate impact and initiate updates to internal processes as needed.
• Assess, document, and track complaints, deviations, and CAPAs to ensure timely, thorough, and effective resolution and preventive action.
• Operate in compliance with the Blue Earth Diagnostics Quality Management System and regulatory requirements.
• Train, coach and support Blue Earth Diagnostics personnel in quality and compliance requirements.

Education

A degree in a science related discipline is desirable.

Professional Experience, Knowledge & Technical Skills

• Comprehensive knowledge of EU GMP regulatory legislation and ICH guidelines obtained within sterile and/or radiopharmaceutical Manufacturing operations. Knowledge of US CFR is desirable.
• Experience with hosting or acting as SME for Regulatory Authority GxP inspection process.
• Trained GxP auditor or having sufficient knowledge and experience to perform GxP audits and to assess, select and manage/oversee contract GxP auditors and maintain the audit schedule.
• Experience with Positron Emission Tomography (PET) or radiopharmaceutical products is strongly preferred.
• Demonstrated experience overseeing and managing third-party Contract Manufacturing Organizations (CMOs) or other suppliers, including performance monitoring and issue resolution.
• Comprehensive understanding of Quality Management System (QMS) principles, quality oversight, deviation management, CAPA, change control, and quality risk management practices.
• Proven ability to collect, consolidate, analyze, and interpret operational and quality performance data to generate meaningful information
• Willingness to travel within the EU up to ~30%, with occasional trans-continental travel as needed.

Soft Skills – Company Values & Behaviours

• Excellent investigation, problem solving, and report writing skills.
• Excellent written and verbal communication skills, negotiation, collaboration, and interpersonal skills with ability to work effectively with others at all levels of the organization.
• Ability to influence and build relationships/earn credibility quickly across broad global constituencies with competing priorities.
• Highly skilled or advanced knowledge of Microsoft 365 package (i.e., Word, Excel, PowerPoint) and experience with Power BI is desired but not essential.

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