Quality Manager / QP / Responsible Person Bausch + Lomb (NYSE/TSX: BLCO) is a leading global eye health company dedicated to protecting and enhancing the gift of sight for millions of people around the world—from the moment of birth through every phase of life. Our mission is simple, yet powerful: helping you see better, to live better. Our comprehensive portfolio of over 400 products is fully integrated and built to serve our customers across the full spectrum of their eye health needs throughout their lives. Our iconic brand is built on the deep trust and loyalty of our customers established over our 170-year history. We have a significant global research, development, manufacturing and commercial footprint of approximately 13,000 employees and a presence in approximately 100 countries , extending our reach to billions of potential customers across the globe. We have long been associated with many of the most significant advances in eye health, and we believe we are well positioned to continue leading the advancement of eye health in the future. This position is based in Dublin working on a hybrid model. The Quality Assurance Manager, QP/RP at Bausch + Lomb Ireland Limited has responsibility for the management and maintenance of BLIL Quality Management System. Furthermore, the job holder is acting as qualified person as per EU GMP and responsible person as per EU GDP requirements. KEY RESPONSIBILITIES: Responsibilities include but are not limited to: Manage the QMS, ensure the QMS is fit for purpose, making changes as necessary approving SOPs and Quality System documents. Maintain Quality processes in support of BLIL authorizations (WDA, MIA, ASR) Ensure processes are maintained in support of BLIL as MAH Manage communications with and represent BLIL in front of HPRA. Provide QA expertise to BLIL and manage any Quality issues that arise to closure. Support HPRA inspections of BLIL and prepare written responses to inspections. Support Bausch + Lomb internal compliance audits of the BLIL operations. Prepare and approve HPRA variations. Provide QA oversight and expertise for New Product Introductions Review and approve Non-Conformances (NC), CAPA, change controls and complaints. Ensure annual review of supplier and customer bona fides to verify compliance with Guidelines on Good Distribution Practice. Ensure Batch record review to verify compliance with GMP and Market Authorization prior to batch release. Review, and where appropriate, preparation and regular update of technical agreements with licensees and 3rd party contractors. Regular presentation and review of intercompany Quality service provider performance against measures relating to the BLIL Quality Objectives at periodically held Quality Operations meetings. Periodic review of QMS and operational procedures for regulatory compliance through internal audit system. Scheduling periodic Quality Operations management review meetings with third parties, annual Quality Management Review meetings, and preparing the agenda and minutes for both meetings. Attending the annual Quality Management Review meeting and participating in the review of the BLIL Quality and Regulatory Compliance Policy and Objectives for continuing suitability. Implementation of the Self Inspection/Internal Quality Audit program. Overall responsibility for reporting and investigation of non-conformances and identification of CAPAs to ensure continuous improvement of the QMS and operational procedures. Escalation of issues as appropriate. The QP must be eligible to act as a European Qualified Person (QP), certifying products in compliance with 2001/83/EC, 2003/94/EC and Annex 16. The RP must be eligible to act as EU GDP responsible person as per EU GDP guideline. PERSON SPECIFICATION BSc (Hons) in Science or equivalent. Thorough working knowledge of GMDPs and regulatory expectations for medicinal products and medical devices. Minimum of 5 years of experience working in Quality Assurance in the Health Care Industry. Ability to work on their own initiative and within teams. Be able to analyse complex problems and identify solutions. Strong communication and organizational skills. Excellent ability to deliver results, with strong interpersonal and influencing skills. Ability to build relationships internally and externally. Trained auditor. Available to travel if required to fulfil role. Bausch & Lomb is committed to equal employment opportunity and complies with equal employment opportunity laws in effect wherever it operates. #J-18808-Ljbffr
Select how often (in days) to receive an alert: Location: IE - Waterford, Ireland - All, IE Bausch + Lomb (NYSE/TSX: BLCO) is a leading global eye health company dedicated to protecting and enhancing the gift of sight for millions of people around the world—from the moment of birth through every phase of life. Our mission is simple, yet powerful: helping you see better, to live better. Our comprehensive portfolio of over 400 products is fully integrated and built to serve our customers across the full spectrum of their eye health needs throughout their lives. Our iconic brand is built on the deep trust and loyalty of our customers established over our 170-year history. We have a significant global research, development, manufacturing and commercial footprint of approximately 13,000 employees and a presence in approximately 100 countries , extending our reach to billions of potential customers across the globe. We have long been associated with many of the most significant advances in eye health, and we believe we are well positioned to continue leading the advancement of eye health in the future. This position is based in Waterford, on a 4 cycle shift pattern. Implement preventative maintenance programmes (CBM & Planned Maintenance). Monitor and drive improvements in the effectiveness of all maintenance activities. Develop training plans and set goals for technicians. Lead daily Tier 1.5 meeting and prioritise resources to maximise lens output while maintaining quality and safety compliance. Own, monitor, report on and implement improvements to increase equipment OEE. Provide details of OEE detractors and collaborate with Engineering on improvement plans. Participate in the recruitment of staff as required. Work with Procurement and Logistics groups on the control of equipment spares. Work with Engineering to develop a predictive maintenance system. Complete Quality and Safety CAPA activities. Ensure all work is executed in line with health and safety and quality system requirements. Oversee the planning and execution of day-to-day maintenance, repairs and troubleshooting. Requirements Education: Bachelors Degree in Engineering or other relevant technical equivalent. Experience: 5+ years of experience in engineering / maintenance roles in high-volume industries with significant automation. 3+ years supervisory experience. Extensive hands-on experience of preventive / reactive maintenance and technician supervision / interaction. Knowledge of medical device and/or pharmaceutical production preferred (cGMP / FDA regulated environment). Self-directed with excellent communication skills. Demonstrates effective communication of technical issues and their corrective and preventive actions. Sets the standard of a right first time approach to maintenance and repair activities Bausch & Lomb is committed to equal employment opportunity and complies with equal employment opportunity laws in effect wherever it operates. #J-18808-Ljbffr
Quality Manager / QP / Responsible Person Bausch + Lomb (NYSE/TSX: BLCO) is a leading global eye health company dedicated to protecting and enhancing the gift of sight for millions of people worldwide—from birth through all life stages. Our mission: helping you see better, to live better. Our portfolio of over 400 products is fully integrated, serving customers across the entire spectrum of eye health needs. With a 170-year history, our trusted brand is supported by a global footprint of approximately 13,000 employees in around 100 countries, reaching billions of potential customers. We have contributed significantly to advancements in eye health and aim to continue leading in this field. This position is based in Dublin, adopting a hybrid work model. The Quality Assurance Manager, QP/RP at Bausch + Lomb Ireland Limited, is responsible for managing and maintaining the Quality Management System (QMS). The role also involves acting as the qualified person (QP) under EU GMP and the responsible person (RP) under EU GDP requirements. KEY RESPONSIBILITIES: Manage and ensure the effectiveness of the QMS, including approving SOPs and quality documents. Maintain quality processes supporting BLIL authorizations (WDA, MIA, ASR). Support BLIL as a Marketing Authorization Holder (MAH). Communicate with and represent BLIL to authorities like the HPRA. Provide QA expertise and manage quality issues to resolution. Support and prepare for HPRA inspections, including drafting responses. Support internal compliance audits and prepare HPRA variations. Oversee QA for new product introductions. Review and approve non-conformances, CAPA, change controls, and complaints. Verify supplier and customer compliance with Good Distribution Practice. Review batch records for GMP and market authorization compliance before release. Manage technical agreements with licensees and third-party contractors. Present and review quality performance at operational meetings. Conduct internal audits and review QMS and operational procedures for compliance. Organize and participate in management review meetings, preparing agendas and minutes. Implement and oversee internal quality audits. Investigate non-conformances, report findings, and implement CAPAs for continuous improvement. Escalate issues as needed. The QP must be eligible to act as a European Qualified Person, certifying products in accordance with relevant EU directives. The RP must be eligible to act as the EU GDP responsible person per EU GDP guidelines. PERSON SPECIFICATION: BSc (Hons) in Science or equivalent qualification. Thorough knowledge of GMDPs and regulatory expectations for medicinal products and medical devices. Minimum of 5 years’ experience in Quality Assurance within the healthcare industry. Ability to work independently and in teams. Strong analytical, problem-solving, communication, and organizational skills. Proven ability to deliver results, with interpersonal and influencing skills. Ability to build internal and external relationships. Trained auditor certification. Willingness to travel if required. Bausch & Lomb is committed to equal employment opportunity and complies with applicable laws. #J-18808-Ljbffr
Select how often (in days) to receive an alert: Bausch + Lomb (NYSE/TSX: BLCO) is a leading global eye health company dedicated to protecting and enhancing the gift of sight for millions of people around the world—from the moment of birth through every phase of life. Our mission is simple, yet powerful: helping you see better, to live better. Our comprehensive portfolio of over 400 products is fully integrated and built to serve our customers across the full spectrum of their eye health needs throughout their lives. Our iconic brand is built on the deep trust and loyalty of our customers established over our 170-year history. We have a significant global research, development, manufacturing and commercial footprint of approximately 13,000 employees and a presence in approximately 100 countries , extending our reach to billions of potential customers across the globe. We have long been associated with many of the most significant advances in eye health, and we believe we are well positioned to continue leading the advancement of eye health in the future. This position is based in Dublin on a hybrid working model of 3 days on site, 2 days in the office. The Quality Assurance Manager, RP at Bausch + Lomb Ireland Limited has responsibility for the management and maintenance of BLIL Quality Management System. Furthermore, the job holder is acting as qualified person as per EU GMP and responsible person as per EU GDP requirements. KEY RESPONSIBILITIES: Responsibilities include but are not limited to: Manage the QMS, ensure the QMS is fit for purpose, making changes as necessary approving SOPs and Quality System documents. Maintain Quality processes in support of BLIL authorizations (WDA, MIA, ASR) Ensure processes are maintained in support of BLIL as MAH Manage communications with and represent BLIL in front of HPRA. Provide QA expertise to BLIL and manage any Quality issues that arise to closure. Support HPRA inspections of BLIL and prepare written responses to inspections. Support Bausch + Lomb internal compliance audits of the BLIL operations. Prepare and approve HPRA variations. Provide QA oversight and expertise for New Product Introductions Review and approve Non-Conformances (NC), CAPA, change controls and complaints. Ensure annual review of supplier and customer bona fides to verify compliance with Guidelines on Good Distribution Practice. Ensure Batch record review to verify compliance with GMP and Market Authorization prior to batch release. Review, and where appropriate, preparation and regular update of technical agreements with licensees and 3rd party contractors. Regular presentation and review of intercompany Quality service provider performance against measures relating to the BLIL Quality Objectives at periodically held Quality Operations meetings. Periodic review of QMS and operational procedures for regulatory compliance through internal audit system. Scheduling periodic Quality Operations management review meetings with third parties, annual Quality Management Review meetings, and preparing the agenda and minutes for both meetings. Attending the annual Quality Management Review meeting and participating in the review of the BLIL Quality and Regulatory Compliance Policy and Objectives for continuing suitability. Implementation of the Self Inspection/Internal Quality Audit program. Overall responsibility for reporting and investigation of non-conformances and identification of CAPAs to ensure continuous improvement of the QMS and operational procedures. Escalation of issues as appropriate. It is desirable to have a QP qualification must be eligible to act as a European Qualified Person (QP), certifying products in compliance with 2001/83/EC, 2003/94/EC and Annex 16. The RP must be eligible to act as EU GDP responsible person as per EU GDP guideline. PERSON SPECIFICATION BSc (Hons) in Science or equivalent. Thorough working knowledge of GMDPs and regulatory expectations for medicinal products and medical devices. Minimum of 5 years of experience working in Quality Assurance in the Health Care Industry. Ability to work on their own initiative and within teams. Be able to analyse complex problems and identify solutions. Strong communication and organizational skills. Excellent ability to deliver results, with strong interpersonal and influencing skills. Ability to build relationships internally and externally. Trained auditor. Available to travel if required to fulfil role. Bausch & Lomb is committed to equal employment opportunity and complies with equal employment opportunity laws in effect wherever it operates. #J-18808-Ljbffr
Join our team! We are a global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health outcomes. We develop, manufacture and market a range of products, primarily in gastroenterology, hepatology, neurology, dermatology, medical aesthetic devices and international pharmaceuticals. Our 7,000 employees share a common goal and values, propelling us to provide essential care to millions of people globally. We seek dedicated individuals who share our sense of urgency, unity, and excellence. We are looking for a trustworthy, respectful individual who consistently makes decisions based on integrity and accountability. A self-motivated, imaginative, and proactive person with a keen eye for opportunities and solutions. The ideal candidate will be adaptable, action-oriented and disciplined, with the ability to manage multiple tasks effectively. If you’re a focused and accountable professional who thrives in a collaborative environment, we’d love for you to join us. Be part of a culture that doesn’t wait for change but actively creates it—where we are all in it together to make a difference and your skills and values drive our collective progress and impact. The Professional Affairs Manager (EMEA) The Professional Affairs Manager (EMEA) is accountable for designing & executing Solta’s EMEA education strategy, developing & nurturing relationships with internal & external stakeholders, and playing a key role in guiding innovation pipelines and medical communications based on R&D and commercial strategies. This role will also be a thought partner to the global business on strategies related to claims requirements, evidence generation plans, clinical study approach, and R&D innovation pipeline. Key Responsibilities: Lead the execution of Solta professional programs in EMEA including facilitation, coordination and management of KOLs, global and regional Medical and Scientific advisory boards, stakeholders, logistics and vendors to ensure that programs are conducted efficiently, effectively, and compliantly. Collaborate with cross-functional partners to support the team on medical insights, technology, and Key Opinion Leader (KOL) insights & engagement. Lead, supervise, and participate in the execution of company-sponsored workshops and educational programs. Interact with external customers/doctors to convey strategic vision, clear and appropriate messaging, to create deep business relationships. Lead Professional projects through application of customer insights and strategic planning to develop and implement new education offerings to meet business plan requirements. Develop measurable project plans with clear objectives, milestones, resource requirements, and deliverables. Manage priorities to ensure maximum effectiveness. Translate customer insights to the broader organization. Utilize metrics for process improvement. Review and drive consistency on professional affairs related materials and communications globally. Help guide evidence generation plans or clinical studies needs to differentiate SOLTA devices from the competition via customer insights. Understand and utilize existing and new technology to effectively reach multiple stakeholders to engage and reinforce key learning concepts throughout the Education Continuum; optimize the education modality for the most effective and efficient approach. Apply strategic and big picture thinking in developing professional services structure, approach with buy-in from stakeholders. Business planning and budget forecasting to ensure strategy aligns with broader organizational goals. The Minimum Requirements: A minimum of a bachelor’s degree is required in the clinical field. 5+ years of experience in professional, clinical and/or medical affairs within the medical device industry. Knowledge in key specialties aligned to the role is required, such as adult learning methodologies, e.g., building curriculum for healthcare providers. KOL interaction/management. Strong understanding of technology and the ability to lead web-based meetings and customer-facing events expertly and articulately. Requires up to 50% travel. The masculine is used in this publication without prejudice for the sake of conciseness. Bausch Health is committed to equal employment opportunity and complies with equal employment opportunity laws in effect wherever it operates. #J-18808-Ljbffr
