Quality Assurance Manager

Curium Pharma; Dublin; On-site; EUR 90,000 - 120,000; Full time

Benefits offered by this job

Competitive salary and benefits

Job summary

Curium Pharma is seeking an experienced Site Quality Lead / Qualified Person (QP) to spearhead Quality, compliance and operational excellence at our Dublin site. You will lead QA and QC, drive regulatory readiness and partner with HPRA and other authorities.

You will own the QMS, approve batch documentation, investigations and CAPAs, while developing a culture of quality and continuous improvement across the site.

Qualifications

• Qualified Person (QP) with HPRA licence and at least 5 years of HPRA-licenced experience.
• 5–10 years in Quality Management Systems and GMP environments.
• Strong knowledge of EU GMP and HPRA requirements for medicinal products.

Responsibilities

• Act as Qualified Person (QP) and lead the QA/QC teams.
• Oversee deviations, CAPAs, change controls, and product quality reviews.
• Own the site Quality Management System and ensure data integrity.

Skills

QP (Qualified Person)

HPRA licence experience

Quality management

Leadership

Regulatory knowledge

Education

Pharmacy / Chemistry degree

Tools

QMS (Quality Management System)

Job description

Curium is the world's largest nuclear medicine company with more than a century of industry experience. We develop, manufacture, and distribute world-class radiopharmaceutical products to help patients around the globe. Our proven heritage combined with a pioneering approach are the hallmark of delivering innovation, excellence, and unparalleled service.

Join us as a QA Manager!

We are looking for an experienced Site Quality Lead / Qualified Person (QP) to lead our Quality function and play a key role in ensuring the highest standards of quality, compliance and operational excellence at our site.

What You'll Do:

Quality & Regulatory Leadership

• Act as Qualified Person (QP) and named Quality Controller on the company licence.
• Ensure site compliance with HPRA requirements, EU GMP, Product Licences, European Pharmacopoeia and applicable pharmaceutical legislation.
• Lead the Quality Department, covering both QA and QC.
• Maintain inspection readiness and act as a key contact for HPRA and other regulatory authorities.
• Lead regulatory inspections, internal audits/self-inspections and supplier audits.

Product Release & Quality Management

• Approve batch documentation, QC results and product release.
• Oversee deviations, OOS investigations, CAPAs, change controls and Product Quality Reviews.
• Own and continuously improve the site Quality Management System (QMS).
• Ensure manufacturing and analytical processes remain compliant, validated and aligned with data integrity requirements.
• Maintain the Validation Master Plan and GMP documentation and training programmes.

Quality Culture & Continuous Improvement

• Build and embed a culture of quality and excellence across the site.
• Drive continuous improvement and ensure quality objectives are integrated into site operations.
• Partner with Production and Site Leadership to deliver business objectives while maintaining full compliance.

Customer & Product Quality

• Lead investigations into product complaints and externally reported quality issues.
• Coordinate product recalls and withdrawals with internal stakeholders and regulatory authorities.
• Ensure appropriate Quality Agreements are in place and liaise with Pharmacovigilance when required.
• Support quality aspects of new product development, including validation of products, processes and equipment.
• Lead, coach and develop the QA/QC teams.
• Set clear expectations, support performance and development, and build succession plans.
• Promote collaboration across the site and participate in site and corporate management meetings.

What You Bring:

• Qualified Person (QP) with at least 5 years' experience on an HPRA licence.
• Degree in Pharmacy, Chemistry, Pharmaceutical Chemistry, Biology or a related discipline.
• 5-10 years' experience in Quality Management Systems and extensive experience working in GMP environments.
• Strong knowledge of EU GMP and current HPRA requirements for medicinal products.
• Proven experience leading teams and managing Quality/QA/QC functions.
• Strong project leadership, communication and stakeholder-management skills.
• Good understanding of regulatory, environmental, health and safety requirements.
• Strategic and commercially minded, with the ability to identify opportunities for business growth and long-term improvement.
• Experience within the radiopharmaceutical sector and knowledge of radiation would be an advantage.
• Strong technical aptitude, sound business understanding and the ability to work effectively in a fast-paced environment.

.

• Working in an advanced radiopharmaceutical environment
• Contributing directly to patient safety and outcomes
• Developing professionally in a supportive, science-led culture
• Competitive salary and benefits package.

Disclaimer

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of employees assigned to this position.

Equal Opportunity Employer

Curium is an equal-opportunity employer and believes everyone deserves respect, dignity, and equality. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.