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Audit Program Manager - Quality Assurance
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 103,000 colleagues serve people in more than 160 countrie
De functie / The role
The Diagnostics division is recruiting for an Audit Program Manager - Quality Assurance who can be home or office based in UK, Ireland, Germany, France, Italy, Spain or Netherlands.
MAIN PURPOSE OF JOB
This position administrates regulatory compliance activities related to the Internal Audit Program. The position is key in the facilitation/execution of the internal inspection process and ensures the Internal Audit Program across the Abbott Diagnostic Division (ADD) Sites/Commercial Affiliate Sites serves to identify Quality System improvements. Independently conducts assigned audits of Suppliers and Third Party Manufacturers (TPM"s) to assess compliance to all applicable external standards and regulations as well as Abbott Quality System requirements at a standard commensurate with regulatory external audits.
Plans and conducts internal audits across the ADD Sites/Commercial Affiliate Sites to assess compliance to all applicable External Standards and Regulations as well as Abbott Quality System requirements.
Identifies compliance risks to current regulations and guides the sites in the planning and execution of Quality System improvements.
Prepares and implements Internal Audit schedules spanning the ADD manufacturing sites, Commercial Affiliate sites, as well as the scheduling and performance of Supplier / TPM audits.
Uses current regulatory trends to identify potential compliance risks or opportunities for improvement in ADD's Quality System.
Conducts internal audits at a standard commensurate with regulatory external audits.
Leads initiatives to address compliance gaps across the Commercial Affiliate Sites. This may include the development of CAPA plans and resulting follow-up guidance activities in support of the Commercial Affiliates to attain the required level of compliance.
Reports progress of audits within Sites and to Division personnel as appropriate.
Provides guidance to applicable "Inspection-Readiness" activities across ADD Sites.
Performs topic specific SIM audits at ADD Sites as requested by management.
Reports audit findings in a timely manner.
Generates and reports internal audit metrics to Site and Division Management.
Maintains files and documentation associated with internal and external inspections.
Participates as SME in audits; provides compliant, and strategic solutions to complex quality issues.
May assist with audit support activities during external audits of Sites.
Leads projects that are cross-functional in scope; directly influences project direction and scope; champions new initiatives and acts as the catalyst for change within and potentially across Divisions
Maintains and demonstrates understanding of global standards, regulations and regulatory bodies
May assume managerial responsibilities as needed
Het profiel / Your profile
Degree preferably in Science or technical discipline such as biology ,chemistry, engineering or Certification in Medical Technology or Quality Management.
Working knowledge of Good Manufacturing Practices (GMPs), Quality System standards and regulatory requirements such as 21 CFR 820, 21 CFR Part 600, ISO 13485, and IVDD etc.
Demonstrated experience in pharmaceutical or medical device industry or other regulated industry.
Trained in auditing techniques; Certified Auditor qualification or equivalent is preferred.
As you"d expect from a global healthcare company, we offer a fantastic range of benefits including competitive salaries, a superb defined contribution pension scheme, private healthcare, life assurance and a flexible benefits scheme.