Senior Director of 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.
As the Senior 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. You will serve as the Responsible Person (RP), i.e. lead the entire quality organization, and play a critical leadership role in maintaining the highest standards of quality and safety for our pharmaceutical products in accordance with GDPR guidelines in addition to our Quality Management System (QMS).
Primary Responsibilities: Lead the quality organization to ensure that GDPR regulations and our QMS conditions are being complied with at all times. Lead and be accountable for the design, implementation, maintenance and continuous improvement of a QMS for the distribution, manufacturing oversight, and supply of pharmaceutical products, based on applicable government standards and local regulatory requirements. Accountable for the design and implementation and ongoing monitoring of our notification system and processes for notifying suppliers in the event of an adverse product event. Provide quality oversight of supply chain activities including shipping, distribution, receiving, and storage activities and deviations from SOPs that have the potential to impact product quality or patient safety. Design and lead the set-up of processes to ensure appropriate communication to the local health authority of any reportable event related to product quality. Develop and lead the monitoring and maintenance of all SOPs (approval, signatures, and date) including training of personnel on relevant product quality processes. Accountable for the preparation and maintenance of accurate and comprehensive quality assurance records related to distribution and supply chain activities, in accordance with regulations. Lead the quality activities for the release for distribution of products, including verifying product disposition, evaluating non-conformance reports and decisions on product release. Establish governance processes and procedures for management of Reference and Retention Samples in alignment with cGMP requirements, and provide oversight of suppliers' manufacturing processes in alignment with cGMP requirements. Lead and be accountable for the review of product testing data in accordance with our QMS. Review, discuss and provide recommendations to suppliers on any product recall. Lead and be accountable for processes and activities in connection with any product recalls in compliance with our QMS, including activities and coordination with suppliers, communication protocols to customers and management of physical returns, track tracing for product lots released for distribution and restriction of inventory. Accountable for the design and execution of supplier audits and inspections to assess compliance with relevant regulatory requirements and standards, and identify areas for improvement or correction and coordination with suppliers on implementation of improvements and corrective actions. Lead the monitoring and assessment the performance of suppliers and vendors to ensure ongoing compliance and product quality. Accountable for the prepare and submission of necessary reports to regulatory authorities, as mandated. Communicate regularly with other quality assurance and regulatory affairs leadership regarding QA/RA activities and issues. Lead a global team of quality, supply chain, and regulatory team members and instill confidence and competence in executing GDPR practices, fostering a culture of quality excellence, accountability and continuous learning. Provide leadership updates regarding the health and initiatives relating to QMS/quality assurance during management reviews. Required Qualifications: Extensive experience in quality assurance roles within the pharmaceutical industry, with a strong understanding of cGMP regulations, quality systems and pharmaceutical manufacturing processes. Practical experience in handling, storage and distribution of medicinal products and transactions in or selling or procuring medicinal products with previous experience as Responsible Person (RP). Certification as a Responsible Person or equivalent, depending on local regulations. Experience in implementation of a Quality Management System. In-depth knowledge and experience with GDPR regulation - Knowledge of the role of the MHRA & HPRA in the licensing of medicines. Knowledge of relevant EU and Ireland-specific regulatory requirements. Strong leadership and communication skills, with the ability to effectively collaborate, influence, and educate stakeholders at all levels of the organization. Preferred Qualifications: Full-time direct GDPR experience. Strong analytical, problem-solving, and communication skills. Attention to detail and a commitment to maintaining high-quality standards. Ability to work collaboratively and effectively with cross-functional teams. 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.
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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