GDP Quality Assurance Lead

Optum is a global organisation that delivers care, aided by technology to help millions of people live healthier lives. The work you do with our team will directly improve health outcomes by connecting people with the care, pharmacy benefits, data and resources they need to feel their best. Here, you will find a culture guided by diversity and inclusion, talented peers, comprehensive benefits and career development opportunities. Come make an impact on the communities we serve as you help us advance health equity on a global scale. Join us to start Caring. Connecting. Growing together. 
In healthcare, evolution doesn’t just happen. It takes innovation, imagination, and a passion for solving problems in new and better ways. And innovation is taking place at a lightning-fast pace every day at Optum. 
As the fastest growing part of the UnitedHealth Group family of businesses, we’re expanding our team in Ireland and creating excellent opportunities for those who want greater purpose and more impact in their work. We’ll provide the investment, support, and resources to advance your career. You’ll provide the talent, ambition, and drive. 

About the role:

At UnitedHealth Group and Optum, we want to make healthcare work better for everyone. This depends on hiring the best and brightest. With a thriving ecosystem of investment and innovation, our business in Ireland is constantly growing to support the healthcare needs of the future. 
Our teams are at the forefront of building and adapting the latest technologies to propel healthcare forward in a way that better serves everyone. With our hands at work across all aspects of health, we use the most advanced development tools, AI, data science and innovative approaches to make the healthcare system work better for everyone. 
The GDP Quality Assurance Lead role will work with the QA and Compliance Management team to ensure that medicines are distributed in the USA in compliance with GDP requirements. The ideal candidate will have extensive experience/knowledge in a GDP (industry) environment, Distribution, Supply Chain and Logistics.

The GDP Quality Assurance Lead  will manage the day-to-day Quality oversight of the Third Party Logistics providers and provide support for key stakeholders. 

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 office and telecommuting from a home-based office in a hybrid work model. 

Primary Responsibilities:

• Support the oversight of Distribution Partners within the USA
• Support vendor qualification activities including qualification of transportation providers
• Support customer qualification process and periodic bona fide checks
• Support deviations, CAPAs and Change Controls
• Support Product Complaints team to ensure that customer complaints are dealt with effectively
• Maintain QMS, Create/review Standard Operating Procedures and other Quality DocumentsQuality oversight of transactions for product distribution to ensure alignment with the approved business model and license
•  Analyze, resolve, or assist in solving compliance and customer issues.
• Maintaining KPIs
• Remain up to date in GDP and logistics developments and emerging regulations to guide the maintenance of the QMS
• Accountable for New Product Launch activities within the US providing distribution requirements and expectations
• Supporting self-inspections process and ensure implementation of CAPAs
• Support recalls, mock recalls and any other on-market activity
• Support the GDP Management Review process; Review and assess the risk of inputs such as metrics, regulatory intelligence, and identified risks and gaps; Recommend mitigation approaches
• Planning/ Preparation/supporting for Regulatory inspections
• Post inspection follow-up with responses and CAPAs (Continuous improvements)
• Support the decision on rejected, recalled or counterfeit medicines, including the approval of returns to saleable stock
• Working collaboratively with key internal stakeholders
• Perform any other duties related to EU and HPRA GDP guidelines
• Ensure that any additional requirements imposed on certain products by national law are adhered to

You will be rewarded and recognised for your performance in an environment that will challenge you and give you clear direction on what it takes to succeed in your role, as well as providing development for other roles you may be interested in.

Required Qualifications:

•  Bachelor’s Degree in a scientific or allied health field (or equivalent degree) 
•  Previous experience in Quality Assurance, Supply Chain Management, Logistics or relevant comparable background
•  Previous experience in vendor qualifications including qualification of carriers and shipping routes
•  In-depth knowledge of GDP guidelines and regulatory requirements
•  Strong analytical and problem-solving skills
• Excellent communication and interpersonal skills
• Attention to detail and a commitment to quality; demonstrated ability to analyze data, identify trends, and implement proactive measures to mitigate risks and improve quality performance

Preferred Qualifications:

• Proficiency in quality management tools and methodologies (e.g., risk assessment, root cause analysis, FMEA) and quality management software systems
• Certification in GDP or related quality assurance standards
•  Experience with regulatory audits and inspections
• Proficiency in using quality management systems and software

Please note you must currently be eligible to work and remain indefinitely without any restrictions in the country to which you are making an application. Proof will be required to support your application.

For more information on our Internal Job Posting Policy, click here.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. © 2025 Optum Services (Ireland) Limited. All rights reserved.

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