Senior Validation Manager

Abbott Ireland (Sligo, Ireland) 28 days ago

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 107,000 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.

MAJOR RESPONSIBILITIES

  • 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 years’ 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

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JOB FAMILY:Operations Quality

DIVISION:ADD Diagnostics

LOCATION:Ireland > Finisklin : Carbury Point, Finisklin Industrial & Technology Park, Sligo

ADDITIONAL LOCATIONS:

WORK SHIFT:Ie - 40.0Hst0 (Ireland)

TRAVEL:Yes, 25 % of the Time

MEDICAL SURVEILLANCE:Not Applicable

SIGNIFICANT WORK ACTIVITIES:Not Applicable

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