Senior Manager Supplier Quality

Job description

JOB DESCRIPTION:About Abbott Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries. Abbott in Ireland Abbott has been operating in Ireland since 1946 and serves the Irish market with a diverse range of healthcare products including diagnostics, diabetes care, medical devices and nutritional products. In Ireland, Abbott currently employs about 6,000 people across ten sites located in Dublin, Donegal, Clonmel, Cootehill, Galway, Kilkenny, Longford and Sligo. Please note any offer of employment for this position is conditional upon the successful completion of a pre-employment medical examination, including drug and alcohol screening, conducted by a medical practitioner designated by the Company. Abbott Diabetes Care Kilkenny Abbott Diabetes Care in Kilkenny, is at the forefront of Diabetes care with the latest technology, to manufacture FreeStyle blood glucose test strips and FreeStyle Sensors for use in diabetes management. Among Abbott Diabetes Care leading brands are the FreeStyle Precision, FreeStyle Lite and FreeStyle Libre systems. This is how you can make a difference at Abbott: About the Role We are seeking an experienced and strategic Senior Manager, Supplier Quality Assurance to provide leadership and oversight of quality assurance activities across Third Party Manufacturers (TPMs) and suppliers. The successful candidate will be responsible for ensuring compliance with applicable regulatory requirements, quality standards, and Quality Agreements while driving continuous improvement across the supplier network. This is a global role and will lead a team of Supplier Quality Engineers across multiple manufacturing locations and geographies, partnering closely with cross-functional stakeholders to ensure products are manufactured to the highest standards of quality, safety, and efficacy. The position plays a critical role in supporting business objectives while maintaining compliance with global medical device and regulatory requirements. Travel up to 40% for this position. Key Responsibilities Provide strategic and functional leadership for Supplier Quality Assurance activities across TPMs and suppliers. Lead and develop a team of Supplier Quality Engineers across multiple manufacturing locations and geographies, fostering professional growth and high performance. Monitor supplier performance and communicate quality trends, risks, and improvement opportunities to senior leadership. Develop, implement, and maintain supplier quality management review programs and quality performance metrics. Act as the primary quality reviewer and decision-maker for significant TPM exception documents, assessing potential impacts on product quality, safety, efficacy, and regulatory compliance. Drive supplier continuous improvement initiatives and support the development of corrective and preventive action plans. Ensure TPMs and suppliers comply with Quality Agreements, applicable regulations, Abbott policies, and quality system requirements. Evaluate and approve supplier-initiated changes, including: New supplier approvals Alternate material qualifications Manufacturing process changes Site transfers and modifications Provide expert Quality Assurance guidance on validation strategies, including product, process, equipment, and analytical method validation and revalidation requirements. Serve as a Subject Matter Expert during internal audits, regulatory inspections, and supplier assessments. Build and maintain strong working relationships with Design & Development, Engineering, Manufacturing, Operations, Quality Control, Quality Assurance, and Quality Systems teams. Manage Supplier Quality budgets and contribute to long-term resource and capacity planning. Support qualification and validation activities for processes, methods, and equipment at TPMs and supplier sites. Lead quality-related activities at external manufacturing sites to ensure safe, effective, and compliant product supply. Education and Experience Bachelor's Degree in: Life Sciences, Physical Sciences, Engineering, Bioengineering, Or a related scientific discipline Minimum of 10 years' experience in supplier quality, supplier management, or related quality functions within a regulated industry. Strong working knowledge of medical device regulations and standards, including: FDA Quality System Regulation (QSR) ISO 13485 European and international quality system requirements Proven experience developing, implementing, and managing quality system procedures and practices across an organization. Demonstrated ability to work effectively in cross-functional environments and influence internal and external stakeholders. Experience leading complex projects, driving problem-solving initiatives, and providing quality leadership. Strong analytical and statistical skills with proficiency in Microsoft Office applications and quality/statistical analysis tools. Proven leadership track record with excellent organizational, communication, and people management skills. Ability to engage effectively across multidisciplinary functions and organizational levels. Knowledge of Design Controls, Verification & Validation (V&V), and manufacturing operations is highly desirable. Professional certifications such as CQE (Certified Quality Engineer), CQA (Certified Quality Auditor), or CQM (Certified Quality Manager) from ASQ are preferred. What we Offer Attractive compensation package that includes competitive pay, as well as benefits such as Family health insurance, Excellent pension scheme Life assurance Career Development Fantastic new facility Growing business plus access to many more benefits. Connect with us at www.abbott.com or https://www.ie.abbott/, on LinkedIn at www.linkedin.com/company/abbott-/, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews. Abbott is an equal opportunities employer. The base pay for this position is N/AIn specific locations, the pay range may vary from the range posted. JOB FAMILY:Operations Quality DIVISION:ADC Diabetes Care LOCATION:Ireland > Kilkenny : Kilkenny Business and Technology Park ADDITIONAL LOCATIONS: WORK SHIFT:Ie - Dl39S8 (Ireland) TRAVEL:Yes, 50 % of the Time MEDICAL SURVEILLANCE:Yes SIGNIFICANT WORK ACTIVITIES:Not Applicable