RxSource is seeking a QA Manager & Qualified Person (QP) for their Dublin facility. The role involves oversight of the Pharmaceutical Quality System and compliance with EU GMP regulations. The ideal candidate will have a Bachelor's degree in Pharmacy or Life Sciences, with over 5 years of relevant Quality experience. Responsibilities include managing audits, quality assurance processes, and ensuring the release of investigational medicinal products. This position is crucial for maintaining the highest quality standards in clinical trial supply services. #J-18808-Ljbffr
At RxSource, our passion is to improve the lives of patients. As a global provider of clinical trial supply services, we support pharmaceutical and biotech partners for clinical trial supply projects by delivering industry leading timelines with our flexible capacity planning and a dedication to achieve the extraordinary. With operations in Canada, the USA, and Ireland, our portfolio of services include; sourcing of commercial products (comparator, co-medications, rescue medications, ancillaries), packaging, labelling and distribution of clinical trial supplies within temperature-controlled conditions through our facilities. Our team and culture are our greatest strengths—driven by our core values, a can‑do attitude, and deep expertise. This is what sets us apart. When you partner with us, your trial is our passion. Position Summary The QA Manager & Qualified Person (QP) is the senior Quality representative at the Dubin, Ireland facility and is responsible for the effective implementation, maintenance, and continuous improvement of the site Pharmaceutical Quality System (PQS) locally. This role provides quality oversight of GMP/GDP operations supporting packaging, labeling, QP certification, and distribution of investigational medicinal products (IMPs) in support of clinical trials. In addition, this role performs Qualified Person (QP) duties in accordance with EU GMP, Annex 13, Annex 16, the Manufacturing/Importation Authorization (MIA), and applicable EU and national legislation, certifying IMP batches for release for clinical trial use. The role serves as the primary site Quality lead, supporting inspections, audits, supplier qualification, quality events management, and training, while partnering cross‑functionally to embed a strong culture of quality and compliance. On‑site Quality personnel will report to the QA Manager & Qualified Person (QP). Responsibilities Ensure ongoing compliance with EU GMP, GDP, HPRA expectations, and internal SOPs. Maintain and continuously improve the site Pharmaceutical Quality System (PQS). Act as Quality lead for the Dubin facility, providing daily QA oversight of operations. Review and approve controlled documents such as SOPs and work instructions. Provide QA oversight for clinical trial related services, including receipt, storage, label printing, secondary packaging and labeling, and distribution of products used in clinical trials. Review and approve clinical packaging and labeling batch documentation. Provide QA oversight of activities such as temperature monitoring, sanitation, environmental controls, calibration, and preventive maintenance. Ensure GMP/GDP facilities, systems, and equipment maintain a qualified/validated state. Review, approve, and manage deviations, CAPAs, change controls, risk assessments, complaints, and investigations within the EQMS ensuring data integrity and timely closure. Lead or support root cause investigations and ensure timely, effective corrective and preventive actions. Support and execute product recalls in accordance with SOPs and legal/regulatory guidance when required. Host and support customer audits, regulatory inspections, and internal self‑inspections. Ensure inspection readiness and timely, compliant responses to audit observations. Serve as a Quality point of contact for customers and regulatory authorities as needed. Qualify, assess, and monitor suppliers and service providers using a risk-based approach. Review and maintain Quality Agreements / Technical Agreements with suppliers and customers. Develop, deliver, and oversee GMP/GDP and SOP training programs and assess training effectiveness. Assess training effectiveness and identify ongoing training needs. Assist in recruiting, onboarding, coaching, and mentoring Quality team members. Promote a proactive quality culture across all functions and levels. Drive continuous improvement initiatives to enhance compliance, efficiency, and quality performance. Track, trend, and report quality metrics to senior management and support management review activities. Stay current with changes in US and global pharmaceutical regulations, guidance, and industry best practices. Qualified Person Responsibilities Act as a named Qualified Person on the site MIA and perform QP duties as defined in site SOPs and Quality Agreements. Certify and release IMP batches in accordance with EU GMP, Annex 13, Annex 16, CTA/IMPD requirements, and national legislation. Ensure that all manufacturing, testing, packaging, and supply chain activities comply with EU GMP and the approved clinical trial authorization. Verify that manufacturing and testing sites are appropriately authorized and GMP compliant. Confirm completeness and compliance of batch documentation, investigations, validations, and QC data prior to certification. Ensure appropriate qualification of starting materials, packaging materials, and suppliers. Maintain appropriate oversight of any delegated QP‑related activities, retaining full accountability for certification decisions. Maintain up‑to‑date QP training and ensure ongoing regulatory and product knowledge. Qualifications Required: Bachelor’s degree in Pharmacy, Life Sciences Engineering, or a related discipline. Educational qualifications meeting EU QP eligibility requirements as defined in Directives 2001/83/EC and applicable national legislation. 5+ years of Quality experience in pharmaceutical manufacturing, clinical trial packaging and labeling, pharmaceutical distribution within a GxP environment. Strong working knowledge of EU GMP, Annex 13, Annex 16, GDP, and HPRA expectations. Experience managing quality systems, audits, deviations, CAPAs, and change control. Proven ability to work cross‑functionally and manage multiple priorities. Preferred Prior experience in a clinical trial supply services organization. Experience serving as a named QP on an MIA IMP. Experience leading or developing other Quality professionals. #J-18808-Ljbffr
