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 United Health 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 United Health 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 Quality Assurance and Compliance Lead will be responsible for ensuring that all distribution activities comply with GDP guidelines and regulatory requirements.
The Quality Assurance and Compliance Lead will work closely with various departments to implement and maintain GDP standards, conduct audits, and provide training to staff.
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:• Assist in the development and implementation of strategies, policies, and procedures to ensure compliance with regulatory requirements and industry standards• Oversee the implementation and maintenance of the quality management system, including the development, implementation, and maintenance of GDP policies and procedures• Responsible for the execution of compliance reviews, 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 the supply chain, warehousing, and transportation teams to ensure the integrity of products throughout the distribution process• 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 GDP matters during regulatory inspections, customer audits, and internal reviews, ensuring successful outcomes and compliance with requirements• Lead preparation for audits, ensuring readiness for regulatory inspections• 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 approachesYou 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 relevant field• Proven direct experience in a similar role within the pharmaceutical or healthcare industry• In-depth knowledge of GDP guidelines and regulatory requirements, including, GDP guidelines, FDA regulations and ICH guidelines• Strong analytical, problem-solving skills and decision-making skills• Extensive experience in quality management tools and methodologies (e.g., risk assessment, root cause analysis, FMEA) and quality management software systems• Excellent communication and interpersonal skills• Proven leadership and team management 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 performancePreferred Qualifications:• Excellent problem-solving skills, with the ability to lead root cause analysis investigations and implement corrective and preventive actions (CAPAs) effectively• Certification in GDP, auditing or related quality assurance standards• Experience with regulatory audits and inspections• Proficiency in using quality management systems and softwarePlease 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.All telecommuters will be required to adhere to the United Health Group's Telecommuter Policy.At United Health 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.
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