Director, Quality Assurance
3 months ago
Director, Quality Assurance – Dublin or Letterkenny / Hybrid
As a Fortune Global top 10 business, we’re one of the world’s leading healthcare companies. We have been supporting global healthcare systems from Ireland for 25 years, building a dynamic and diverse team of more than 2, talented individuals.
With a strong ecosystem of investment and innovation, our business in Ireland is constantly growing to support the healthcare needs of the future. We are excited to introduce a new service line within the Optum network, focused on biosimilar commercialisation. This initiative represents a significant step forward in our commitment to delivering high-quality healthcare and pharma solutions. This role offers the unique opportunity to be at the forefront of something new, where your contributions will directly shape the future direction and success of the business. You’ll enjoy the benefits of working within a well-established company while also experiencing the excitement, agility, and innovation typically found in a new venture.
As the Director of Quality Assurance , you will be based in Ireland and will be responsible for upholding regulatory, compliance and quality standards for the manufacturing, distribution, storage, and supply of pharmaceutical products as well as overseeing other quality assurance activities. As the Quality Assurance Director, you will be a part of a new service line within the Optum network and will support leadership with our quality assurance, quality planning, and quality control efforts. This role plays an important part in ensuring compliance, quality, and operational excellence within our organization.
Careers with Optum offer flexible work arrangements and individuals who live and work in the Republic of Ireland will have the opportunity to split their monthly work hours between our Dublin or Letterkenny and telecommuting from a home-based office in a hybrid work model.
Primary Responsibilities:
• Assist in the development and implementation of quality assurance strategies, policies, and procedures to ensure compliance with regulatory requirements and industry standards
• Support OPS Ireland leadership’s quality system, including OPS Ireland’s development, implementation, and maintenance of quality systems to ensure adherence to regulatory requirements, industry standards, and best practices in pharmaceutical manufacturing
• Support OPS Ireland’s quality assurance procedures, processes, and documentation that ensure the consistent production of safe, effective, and high-quality pharmaceutical products
• Support the execution of internal and external audits to assess compliance with regulatory requirements, identify areas for improvement, and implement corrective and preventive actions (CAPAs) as needed
• Collaborate with cross-functional teams to support alignment on quality objectives, initiatives, and priorities
• Implement quality metrics, key performance indicators (KPIs), and dashboards to monitor the QMS's performance and drive continuous improvement
• Support timely investigation and resolution of deviations, non-conformities, and customer complaints related to product quality, safety, or efficacy
• Serve as a subject matter expert on quality assurance matters during regulatory inspections, customer audits, and internal reviews, ensuring successful outcomes and compliance with requirements
• Support the preparation for audits, including developing SOPs, facilitating FTZ (Foreign Trade Zone) conversations, and ensuring readiness for regulatory inspections
• Provide mentorship, training, and professional development opportunities for quality assurance and global trade team members
Careers with Optum offer flexible work arrangements and individuals who live and work in the Republic of Ireland will have the opportunity to split their monthly work hours between our Dublin or Letterkenny and telecommuting from a home-based office in a hybrid work model.
Required Qualifications:
• Relevant and current work experience in pharmaceutical industry Quality Assurance required, with a strong understanding of cGMP regulations, quality systems, and pharmaceutical manufacturing processes
• In-depth knowledge of regulatory requirements and guidelines governing pharmaceutical quality assurance, including FDA regulations and ICH guidelines
• Proven track record of building and managing high-performing teams of professionals
• Strong leadership and communication skills, with the ability to effectively collaborate, influence, and educate stakeholders at all levels of the organization
• Experience leading regulatory inspections e.g., FDA inspections, and customer audits, with a track record of successful outcomes
• Demonstrated ability to analyze data, identify trends, and implement proactive measures to mitigate risks and improve quality performance
• Proficiency in quality management tools and methodologies (e.g., risk assessment, root cause analysis, FMEA) and quality management software systems
Preferred Qualifications:
• Experience in overseeing global trade operations, including import/export compliance and logistics management
• Excellent problem-solving skills, with the ability to lead root cause analysis investigations and implement corrective and preventive actions (CAPAs) effectively
• Strong organizational skills, attention to detail, and ability to prioritize and manage multiple projects concurrently in a fast-paced environment
All telecommuters will be required to adhere to the UnitedHealth Group’s Telecommuter Policy.
At UnitedHealth Group, our mission is to help people live healthier lives and make the health system work better for everyone. We believe everyone–of every race, gender, sexuality, age, location and income–deserves the opportunity to live their healthiest life. Today, however, there are still far too many barriers to good health which are disproportionately experienced by people of color, historically marginalised groups and those with lower incomes. We are committed to mitigating our impact on the environment and enabling and delivering equitable care that addresses health disparities and improves health outcomes — an enterprise priority reflected in our mission.
Diversity creates a healthier atmosphere: Optum is an Equal Employment Opportunity employer and all qualified applicants will receive consideration for employment without regard to gender, civil status, family status, sexual orientation, disability, religion, age, race, and membership of the Traveller community, or any other characteristic protected by law. Optum is a drug-free workplace. © Optum Services (Ireland) Limited. All rights reserved.
-
Director, Quality Assurance
1 month ago
Dublin, Ireland Optum Full timeDirector, Quality Assurance – Dublin or Letterkenny / Hybrid As a Fortune Global top 10 business, we’re one of the world’s leading healthcare companies. We have been supporting global healthcare systems from Ireland for 25 years, building a dynamic and diverse team of more than 2,000 talented individuals. With a strong ecosystem of...
-
Audit and Assurance Director
3 weeks ago
Dublin, Ireland RSM Ireland Business Advisory Limited Full timeAbout RSM Ireland RSM Ireland is one of the countrys fastest growing advisory firms, specialising in the provision of consulting, audit, and tax services to leading domestic and international mid-market clients. We are a key member of the RSM International network and work closely with over 64,000 colleagues in 820 offices, spanning 120 countries. RSM...
-
Sustainability Assurance
6 days ago
Dublin, Ireland Deloitte Ireland LLP Full timeDeloitte is the biggest professional services Firm in the world making an impact is more than just what we do: it's why we're here. We're driven to create positive progress for our clients, community, people, and the planet. This sense of purpose inspires us to work to the highest standards, to tackle the challenges that matter. Audit & Assurance is one of...
-
Quality Assurance Analyst
3 weeks ago
Dublin, Ireland UniJobs Full timeQuality Assurance Analyst Unijobs on behalf of our public sector client have a requirement for a Quality Assurance Analyst to join their team. The duration of the post is initially 6 months with possible extensions thereafter. Working 35 hours per week the successful candidate will be employed as an agency employee and will be paid an hourly rate of €29.87...
-
Quality Assurance Technician
7 days ago
Dublin, Ireland INFORM3 Recruitment Full timeJob Title Quality Assurance Technician Job Location NorthCo. Dublin Salary €40K - €50K About the Company: Are you an experienced individual within the food Manufacturing sector as a Quality Technician? Out client is currently recruiting for a Quality Assurance Technician to support the Quality Manager and Technical Management function within the...
-
Director of Quality
5 months ago
Dublin, Ireland LEO Pharma Full timeApplication deadline: Location: Dublin D12 E923, Ireland, Ireland Contract type: Permanent Job ID: 2055 Elevate Your Career in a Culture of Excellence in Quality and Continuous Improvement at LEO Pharma! Are you eager to amplify your impact on global healthcare? Join us at LEO Pharma, where your...
-
Quality Assurance
2 months ago
Dublin, Ireland PSC Biotech Ltd Full timeAbout PSC BiotechWho we are?PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory...
-
Quality Assurance Technician
2 weeks ago
Dublin, Ireland Quorum Search Partners Full timeOur client is an award winning, leading FMCG company based in North Dublin. They are looking for a Quality Assurance Technician to join their Quality & Technical team. Reporting to the Quality Lead Technologist and the Head of Quality & Technical, the QA Technician will play a key role in the business. Package 20 days of annual leave per annum Access to...
-
Clinical /Quality Assurance Manager
3 weeks ago
Dublin, Ireland Life Science Recruitment Ltd Full timeClinical /Quality Assurance Manager Our client is a not-for-profit organisation providing care delivery to their service users in their own home in the North Dublin area. They are looking to expand their team by the addition of a Clinical/Quality Assurance Manager who will oversee the companys Clinical & Quality policies by monitoring & instilling a high...
-
Training Analyst-Quality Assurance
3 weeks ago
Dublin, Ireland UnitedHealth Group Full timeTraining Analyst, Quality Assurance- Dublin or Letterkenny / HybridAs a Fortune Global top 10 business, we’re one of the world’s leading healthcare companies. We have been supporting global healthcare systems from Ireland for 25 years, building a dynamic and diverse team of more than 2, talented individuals.With a strong ecosystem of investment and...
-
Quality Assurance Manager
2 months ago
Dublin, Ireland Clinigen Full timeClinigen is a rapidly growing global specialty pharmaceutical and services company with a unique combination of businesses. Our divisions operate in a complex global regulatory environment and ensure that vital medicines are delivered securely on time and wherever they are needed in the world.We are currently 1,100 people headquartered in the UK with global...
-
Dublin, Ireland Viatris Full timeMcDermott Laboratories Limited At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs. Viatris empowers people worldwide to live healthier at every stage of life. We do so via: Access – Providing high quality trusted medicines...
-
Quality Assurance and Training Supervisor
3 weeks ago
Dublin, Ireland UniJobs Full timeQuality Assurance and Training Supervisor Unijobs on behalf of our public sector client have a requirement for a Quality Assurance and Training Supervisor to join their team. The duration of the post is initially 3 months with possible extensions thereafter. Working 35 hours per week the successful candidate will be employed as an agency employee and will be...
-
Quality Assurance Analyst
3 months ago
Dublin, Ireland ISC Full timeCompany Name:Enterprise Registry Solutions LimitedLocation: Dublin, IrelandStatus: Full–Time Permanent We areERS, a leading international registry provider operating out of Dublin, Ireland. We design, build, and operate registry solutions that power public and private sector operations and drive efficient business decisions around the world. Our people...
-
Quality Assurance/Quality Control
2 weeks ago
Dublin, Ireland Lincoln Recruitment Full timeWere hiring an experienced QC/QA to join our clients team, ensuring the highest standards of quality control and assurance on live fire and sprinkler system installation projects. The successful candidate will implement the company's quality control procedures, inspect systems against design specifications, and oversee documentation and compliance processes....
-
Dublin, Ireland Viatris Full timeMcDermott Laboratories Limited At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs. Viatris empowers people worldwide to live healthier at every stage of life. We do so via: Access – Providing high quality trusted medicines...
-
Programme Manager
4 weeks ago
Dublin, Ireland Reperio Human Capital Full timeDirector - Programme Management (Risk, Assurance, PMO)Dublin/HybridMy client is a market leader in the Management Consulting space, looking for seasoned Director-level Programme Managers with solid experience across Programme Risk Management, Assurance, or PMO delivery, with a successful track record of solving client pain-points, driving delivery, and...
-
Dublin, Ireland Grifols Full timeWould you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and...
-
Senior Quality Assurance Associate
4 months ago
Dublin, Ireland TEAM HORIZON Remote Work Freelance Full timeDescription Team Horizon is seeking a Senior Quality Assurance Associate for our Client, who are a leading biotechnology company based in Dublin. Why you should apply: This is an excellent opportunity to join a forward thinking company and work in a state of the art facility. What you will be doing: Testing of primary and secondary...
-
Quality Assurance and Training Supervisor
3 weeks ago
Dublin, Ireland UniJobs Full timeQuality Assurance and Training Supervisor - (Irish Speaking) Unijobs on behalf of our public sector client have a requirement for a Quality Assurance and Training Supervisor - (Irish Speaking) to join their team. The duration of the post is initially 12 months with possible extensions thereafter. Working 35 hours per week the successful candidate will be...
