QA Manager Ireland

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

Job summary

Curium Pharma in Ireland seeks a Lead, Site Quality to ensure HPRA/GMP compliance and to lead the QA/QC teams. You will act as Qualified Person on the site licence, manage regulatory inspections and maintain the Validation Master Plan, ensuring the site remains in a validated state.

You will drive a culture of excellence, oversee product release, CAPAs, deviations and changes, and provide QA support for PET product development, while keeping training and documentation current.

Qualifications

• Degree level in Pharmacy, Chemistry, Pharmaceutical Chemistry or Biology
• Qualified Person
• 5 years on an HPRA license
• 5-10 years' experience in QMS
• Extensive experience in staff management
• Strong leadership and regulatory knowledge

Responsibilities

• Act as Qualified Person (QP) and named Quality Controller on the company licence.
• Ensure GMP, HPRA, EP and SmPC requirements.
• Lead regulatory inspections, responses, internal self-inspections and supplier audits.
• Approve batch documentation, QC results, master templates and product release.
• Review deviations, OOS investigations, CAPAs and changes.
• Own and improve the site QMS; manage deviations, investigations, CAPA and change control.

Skills

Radiation knowledge

Radiopharmaceutical market knowledge

Strategic thinking

Business development

Leadership

Communication skills

Education

Degree in Pharmacy or related

Qualified Person

HPRA license

QMS experience 5-10 years

Job description

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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 hallmarks to deliver innovation, excellence and unparalleled service.

With manufacturing facilities across Europe and the United States, Curium delivers SPECT, PET and therapeutic radiopharmaceutical solutions for life‑threatening diseases to over 14 million patients annually. The name ‘Curium’ honors the legacy of pioneering radioactive researchers Marie and Pierre Curie, after whom the radioactive element curium was named and emphasizes our focus on nuclear medicine. The tagline ‘Life Forward’ represents our commitment to securing a brighter future for all those we serve: An enhanced quality of care for our patients. A trusted partner to our customers. A supportive employer to our valued team.

Summary of Position

Ensure site compliance with HPRA guidelines, Product Licences, current international pharmaceutical legislation and related guidelines, along with company requirements.

Lead the site Quality Department (QA and QC).

Implement and drive a culture of excellence for the site.

Essential Functions

Site Quality & Regulatory Compliance

• Act as Qualified Person (QP) and named Quality Controller on the company licence.
• Ensure compliance with GMP, HPRA, European Pharmacopoeia (EP) and SmPC requirements.
• Maintain inspection readiness and act as key contact for regulatory authorities.
• Lead/coordinate regulatory inspections, responses, internal self-inspections and supplier audits.

Product Release & Quality Control

• Approve batch documentation, QC results, master templates and product release.
• Review/approve deviations, OOS investigations, CAPAs and changes.
• Ensure production and analytical methods remain compliant and validated.
• Oversee Product Quality Reviews and data integrity.

Quality Management System

• Own and continuously improve the site QMS, including deviations, investigations, OOS, CAPA, change control and incoming material release.
• Maintain the Validation Master Plan and ensure operations remain in a validated state.
• Ensure GMP documentation and training programmes are current.
• Promote a strong site-wide quality culture and continuous improvement.

Customer & Product Quality

• Investigate product complaints and externally reported deviations.
• Coordinate recalls/withdrawals with Site Leadership, Production and authorities.
• Ensure Quality Agreements are in place and liaise with Pharmacovigilance when required.
• Manage and develop QA/QC teams, including coaching, performance reviews, career development and succession planning.
• Ensure staff compliance with GMP and company policies.
• Lead site Quality Assurance meetings and participate in corporate/site management meetings.

Business & New Product Development

• Support the Site Lead and Production Manager in achieving commercial and operational objectives while maintaining compliance and budget control.
• Provide QA support for new PET product development, including product/process/equipment validation and facility calibration and maintenance.
• Oversee compliance with quality, safety, health and environmental requirements.

Requirements

- Knowledge of radiation (Desirable)
- Sound knowledge of radiopharmaceutical market (Desirable[NL1.1][HP1.2])
- To include current product range and novel/pipeline products
- Strategic thinker, able to see long-term opportunities
- Successful in business development, has a history of business growth

Education/experience - Educated to degree level in Pharmacy, Chemistry, Pharmaceutical Chemistry or Biology (Desirable)
- Qualified Person
- 5 years on an HPRA license
- Project leadership skills
- 5-10 years' experience in QMS
- Extensive experience in the overall management of staff
- Extensive experience in the operation of GMP facilities
- Sound understanding of the regulatory and compliance requirements of the business, particularly with regard to quality, environmental, safety and health
- Strong leadership skills
- Sound knowledge of general management practices and business
- High technical aptitude as well as good communication and interpersonal skills
- Stress handling
- Excellent and up-to-date working knowledge of current EU GMP and HPRA requirements for medicinal products

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 anequal opportunity employerand believes everyone deserves respect, dignity and equality. All applicants will be considered for employmentwithout attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.