Overview
Quality Specialist Jobs in Dublin, County Dublin, Ireland at HealthBeacon
Title: Quality Specialist
Company: HealthBeacon
Location: Dublin, County Dublin, Ireland
About the Company – HealthBeacon is a leader in digital health therapeutics with headquarters in Dublin and offices in Richmond, Virginia and Orlando, Florida. We connect people to better health through sustainable, digitally-enabled solutions.
About the Role – The Quality Specialist plays a pivotal role in ensuring compliance and quality excellence across all areas of the business. This role involves cross-departmental collaboration and supports HealthBeacon’s commitment to innovation, compliance, and patient-focused care.
Responsibilities
Quality Management
Support the Regulatory Affairs Manager in reviewing, implementing, and assessing processes and procedures in accordance with GDPR legislation, ISO27001, EPA, and FDA, European, and other regulatory requirements.
Manage and maintain the eQMS, to support quality processes and compliance with regulatory and business requirements.
Assist with maintaining Environmental Management System to maintain compliance with the HB EPA license conditions.
Support external inspections and audits by regulatory authorities or clients.
Investigate and document deviations, ensuring root cause analysis is thorough and accurate.
Coordinate and oversee CAPA implementation and effectiveness checks.
Collaborate with relevant stakeholders to implement the change control process as necessary.
Maintain documentation and records for change control activities.
Conduct quality risk assessments for processes, products, and systems.
Participate in the HB internal auditing process.
Support supplier management activities and ensure performance reviews are performed and documented.
Develop and deliver training for staff on quality processes.
Other activities as requested by the Regulatory Affairs Manager.
Pharmacovigilance (PV)
Provide reconciliation reports to clients on a monthly/quarterly/annual basis.
Source Document Verification (SDV) and Quality Control Checks.
Carry out Quality Control checks as required.
Participate in PV audits.
Maintain and improve the pharmacovigilance system, including SOP updates and training.
Qualifications
Minimum 3 years’ experience in a quality or pharmacovigilance role.
Bachelor’s degree in a scientific discipline.
Direct experience in the following is desired;
Document control
Conducting internal and supplier audits
Investigating deviations and conducting RCAs
Identifying and implementing CAPAs
Developing and delivering training material
AE reconciliations and SDV
EPA licensing compliance
Performing risk assessments
Strong analytical and problem-solving abilities.
High attention to detail.
Learn quickly and exhibit tech savviness.
Team player with a high level of personal initiative; ability to prioritize effectively.
Excellent written and verbal communication skills, with the ability to prioritize and work independently.
Foster a culture of openness, compliance, innovation, and best practice.
What We Offer
An opportunity to make a meaningful impact in the digital health industry.
Collaboration with a diverse, dynamic, and innovative team.
Great opportunities with a global company.
Equal Opportunity Statement – HealthBeacon is an equal opportunity employer committed to creating an inclusive workplace. We do not tolerate discrimination based on race, gender, age, disability, or any other protected status. We value diversity and encourage applications from all qualified candidates.
