Optum is a global organisation that delivers care, aided by technology to help millions of people live healthier lives.
About the Role
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.
Key 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
Requirements
* 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
We believe everyone - of every race, gender, sexuality, age, location and income - deserves the opportunity to live their healthiest life. 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.