Ash Spec Ireland LtdAre you the kind of person that is always thinking, sketching, seeking, and adjusting? Who needs to understand how things work and then figure out how they can work better? Are you a passionate, tenacious, solver who loves to work with others who share your drive? Are you positive, constructive, and ingenious?Are you always solving?Then we’d like to meet you and bet you’d like to meet us.Ashland has an exciting opportunity for a Quality Manager to join our Life Sciences business at our Mullingar, Ireland location. This is a very visible, significant role within the Company and the Quality function. This position will report to Quality Director (Global).The responsibilities of the position include, but are not limited to, the following:Fulfilling the role of management representative including:Representing Ashland in company visits and auditsEnsuring that processes needed for the quality management system are established, implemented and maintainedReporting to top management on the performance of the quality management system and any need for improvementEnsuring the promotion of awareness of regulatory and customer requirements throughout the organizationSupervise the Quality Assurance Specialists and Quality Control TechniciansUpkeep and maintenance of the Quality Management System within AshlandImplementation of documents, training and strategies to ensure Quality levels meeting requirements of the ISO 13485, ISO 9001 and EXCiPACT guideline standardsManagement and delegation over activities in sub-teams including completion of tasks towards quality improvementSome overlap working with team to design and develop of new innovative products, including concept development, high-level design feasibility, prototype development, detailed design, test method development, design verification/validation, shelf-life determination and product commercializationProject management of a team, delegation of tasks, decision making, company representation in quality related areasPreparation of technical documentation in accordance with regulatory and with the company's processesConducting regular management reviews as management representative for quality within companyManagement of CAPA’s/NCRSLead audit representative in company visitsLeading team through audits and navigating regulatory requirementsActively contribute to the organizational goals by taking initiative, executing on goals and focusing on performance and safetyImprove the organization capacity and capabilities through building collaborative relationships, optimizing diverse talent and utilizing positive communications and influence with othersIn order to be qualified for this role, you must possess the following:Level 8 or above qualification in a related discipline (science, tech, engineering, manufacturing)A technical master’s degree or PhD in a related discipline is advantageous but not compulsoryDemonstrated knowledge in pharmaceutical and/or chemical manufacturing operation (e.g. Manufacturing, Quality etc)A minimum of 3 years+ experience in the pharmaceutical industry or a similar operating environment which includes significant leadership roles with experience in a front-line supervisory role in an operation environmentQuality Management & regulatory compliance requirements in alignment with the IPEC GMP and ISO 13485:2016, ISO 9001.Proven experience in managing key elements of QMS e.g., Change Management (MOC), NCR/process deviation, CAPAs, Supplier Management, Risk Management, auditing and handling of Customer complaintsUnderstanding of equipment qualification and process validation requirementsExperience with Medical Device Regulations including ISO 13485 (Quality Management Systems) and ISO 14971 (Risk Management)Proven Project Management and Team Participation experienceCertified auditor qualification (e.g. IRCA Lead Auditor) would be advantageousA demonstrated track-record of being part of successful cross-functional product development teamsAdvanced problem solving, decision making and root cause analysis skillsKnowledge of and experience in applying Six Sigma and Lean methodologiesDemonstrated responsible and ethical behavior at all timesThe ability to help the company drive greater value through understanding the business, making complex decisions and creating the new and different In more than 100 countries, the people of Ashland LLC. (NYSE: ASH) provide the specialty chemicals, technologies and insights to help customers create new and improved products for today and sustainable solutions for tomorrow. Our chemistry is at work every day in a wide variety of markets and applications, including architectural coatings, automotive, construction, energy, personal care and pharmaceutical. Visit www.ashland.com to see the innovations we offer. At Ashland our vision is to be a leading, global specialty chemicals company whose inspired and engaged employees add value to all we touch. In fact our people, employees, customers and vendors define who we are. They are the driving force behind everything we do. Not only do we value our customers but we value our employees, and we work to offer them a dynamic and challenging environment. We hold ourselves to high standards at Ashland, and we value integrity and honesty. Ashland has a history of attracting the best people and keeping them. The reasons are simple: industry competitive salary and benefits, pay-for-performance incentive plans and a diverse work environment where employees feel challenged and valued. People come to Ashland and stay. As a growing Fortune 500 specialty chemicals company, we offer opportunities for development and advancement throughout our global organization. Our values define who we are and what we care about as a company. If you are looking for a relationship with a company instead of simply a job, this may be a great fit.Ashland is proud to be an Equal Opportunity Employer Minorities/Women/Veterans/Disabled/Gender Identity/Sexual Orientation. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity, sexual orientation, national origin, or protected veteran status and will not be discriminated against on the basis of disability. NOTE: We do not accept resumes from external staffing agencies or independent recruiters for any of our openings unless we have a signed recruiting agreement in place to fill a specific position.