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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 2,000 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. © 2024 Optum Services (Ireland) Limited. All rights reserved.