Quality Manager - Ireland
Are 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?
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 the Quality Director (Global).
The responsibilities of the position include, but are not limited to, the following:
* Fulfilling the role of management representative including:
o Representing Ashland in company visits and audits
o Ensuring that processes needed for the quality management system are established, implemented, and maintained
o Reporting to top management on the performance of the quality management system and any need for improvement
o Ensuring the promotion of awareness of regulatory and customer requirements throughout the organization
o Supervise the Quality Assurance Specialists and Quality Control Technicians
* Upkeep and maintenance of the Quality Management System within Ashland
* Implementation of documents, training, and strategies to ensure Quality levels meeting requirements of the ISO 13485, ISO 9001, and EXCiPACT guideline standards
* Management and delegation over activities in sub-teams including completion of tasks towards quality improvement
* Some overlap working with the team to design and develop 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 commercialization
* Project management of a team, delegation of tasks, decision making, company representation in quality-related areas
* Preparation of technical documentation in accordance with regulatory and the company's processes
* Conducting regular management reviews as management representative for quality within the company
* Management of CAPA’s/NCRS
* Lead audit representative in company visits
* Leading the team through audits and navigating regulatory requirements
* Actively contribute to the organizational goals by taking initiative, executing on goals, and focusing on performance and safety
* Improve the organization capacity and capabilities through building collaborative relationships, optimizing diverse talent, and utilizing positive communications and influence with others
In 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 compulsory
* Demonstrated 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 environment
* Quality 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 complaints
* Understanding of equipment qualification and process validation requirements
* Experience with Medical Device Regulations including ISO 13485 (Quality Management Systems) and ISO 14971 (Risk Management)
* Proven Project Management and Team Participation experience
* Certified auditor qualification (e.g. IRCA Lead Auditor) would be advantageous
* A demonstrated track-record of being part of successful cross-functional product development teams
* Advanced problem solving, decision making, and root cause analysis skills
* Knowledge of and experience in applying Six Sigma and Lean methodologies
* Demonstrated responsible and ethical behavior at all times
* The ability to help the company drive greater value through understanding the business, making complex decisions, and creating the new and different
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