QA Manager Ireland

Curium•Ireland, IN

3d•Onsite

About The Position

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.

Requirements

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

Nice To Haves

Knowledge of radiation
Sound knowledge of radiopharmaceutical market
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
Educated to degree level in Pharmacy, Chemistry, Pharmaceutical Chemistry or Biology

Responsibilities

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.
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.
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.
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.
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.