Abbott Senior Validation Manager in Sligo, Ireland
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 109,000 colleagues serve people in more than 160 countries.
Abbott serves the Irish market with a diverse range of healthcare products including diagnostics, medical devices and nutritionals products. In Ireland, Abbott employs over 4,000 people across nine sites. We have six manufacturing facilities located in Clonmel, Cootehill, Donegal, Longford and Sligo and a third-party manufacturing management operation in Sligo. Abbott has commercial, support operations and shared services in Dublin and Galway. We have been operating in Ireland since 1946.
Abbott Ireland Diagnostic Division Sligo
Abbott Diagnostic's is a global leader of in vitro diagnostics with approximately 70,000 institutional customers in more than 100 countries. Our diagnostic products offer a broad range of innovative instrument systems and tests for hospitals, reference labs, blood banks, physician offices and clinics.
Abbott’s diagnostic products offer customers automation, convenience, cost effectiveness and flexibility. Abbott has helped transform the practice of medical diagnosis from an art to a science, helping to create the modern diagnostics industry through the company's commitment to improving patient care and lowering overall costs. The history of Abbott Diagnostics is filled with examples of first-of-a-kind products and significant technological advancements.
PURPOSE OF THE JOB
The incumbent will be responsible as Process Owner for the Validation Process within the ICHP (Immunoassay, Clinical Chemistry, Haematology and Professional Services) areas. This process is a cross Division Process and ownership is shared with the ATM (Abbott Transfusion Medicine) Validation Process Owner. The responsibilities of the roles are to manage and oversee the process to ensure compliance with the relevant regulatory requirements. This position is a Divisional role and reports to the Quality Director, ADD Sligo.
Key Quality and Manufacturing Process Owners are responsible for the oversight and continuous improvement of their process globally.
Act as the Document Owner and can act as Document SME for all global documents associated with the process (e.g. Process-level documents and Learning materials)
Perform periodic review as defined in Operating Procedure Q05.01.011
Ensure that the process remains current, complete, and compliant with Abbott Policy documents and external regulatory requirements as defined in Operating Procedure Q01.12.001
Review all proposed changes as appropriate with the Process Community
Assemble PO/PC Metrics per internal Form 08001 requirements for Management Reviews
Oversight of global investigations and associated corrective/preventive actions
Analyse Tracking and Trending of Nonconformances that have exceeded control limits
Provide support for Nonconformance and Corrective and Preventive Action (CAPA) process as defined in Operating Procedure Q14.14.001
Identify potential Quality Plan projects
Assess documents and Learning Materials for process improvements
Lead process improvement projects
Establish annual goals and strategic direction of the Validation Process Community
Ensure open channels of communication and alignment on approach with ATM Validation Process Owner
Ensure Environmental Health & Safety standards are met and all EHS regulations and procedures are adhered to.
This position does not have any permanent direct reports but may be required to supervise individuals or teams on an as needed basis.
Elevate any areas of potential risk as appropriate mapping out options, risks and recommended path forward
Complete a monthly summary and detailed report for area of responsibility covering achievements, updates, risks.
EDUCATION & COMPETENCIES
Bachelor’s degree preferably in technical/scientific/engineering discipline.
Minimum 5 year’s experience in Quality or Technical role preferably in Management/Supervisory role
Minimum 5 years Medical Device Industry experience in validation
Validation SME knowledge
Results driven with a collaborative style and positive attitude
Experience of working in a matrix organisation and liaising with cross-functional teams
Excellent communication and interpersonal skills with an ability to effectively manage all stakeholders, including effective conflict resolution
Proven track record of proactively seeking feedback and driving continuous improvement
Demonstrated experience of effective decision skills.
Connect with us at www.abbott.com , on LinkedIn at www.linkedin.com/company/abbott-/ , on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email firstname.lastname@example.org