Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.

The Global QA Specialist – Global Audit and Compliance is responsible for providing QA general support for the evaluation of the compliance status of Global GMP/GCP Suppliers, Third-Party Manufacturers (TPMs), Contract Manufacturing Operations (CMOs) and EPD Internal Manufacturing sites/locations that fall under the responsibility of EPD Global Audit.

The position reports to the Associate Director QA Global Audit and Due Diligence

The function serves to support a strategic global purpose for Abbott, with responsibility for GMP/GDP/GLP Global Audit program. The function leads and manages the Global Audit schedules (internal and external), as well as support with due diligence activities for product acquisition and in-licensing deals. Position also provides support for Global Auditor/Divisional Goals and initiatives.

The individual interacts with Division functions (Global Supplier/TPM QA, Global I&D QA, Global Distribution QA, Division Compliance) as well as with Regional and site functions for audit/project/metrics related activities

Core Job Responsibilities

• Manage back office Global Audit work related to audit scheduling, audit preparation coordination with all relevant stakeholders, audit record updates in Trackwise, audit data analysis and metrics management.

• Ensure that annual Global Audit schedules are created, in alignment with all relevant stakeholders, issued and regularly updated

• Support with the management of audit exceptions (i.e. missed audit frequency) and with completion of timely completion of any actions assigned to Global Audit

• Ensure that all audit related information is documented into the Audit Tracking system in a timely manner.

• QA support for all elements needed to facilitate new Licenses and Acquisition deals and associated product launch.

• Support with all activities required to plan, execute, report and close the audits assigned to Global Auditors

• Support with creation/update of supplier agreement with audit service providers in alignment also align with Global Legal requirements

• Manage time management system (Planisware) setup and updates for all Global Audit team

• Support with the review of Quality Questionnaire returned by the Suppliers/TPMs and resolve any issue, where required

• Support with timely completion of post audit activities (i.e. CAPA follow-up, scheduling of follow-up audits) for supplier and TPMs globally.

• Timely information of any audit refusal received by Suppliers of TPMs and support with any proposed remediating/mitigating action

Minimum Education and Experience

• Bachelor Degree or equivalent level of education at a relevant scientific discipline or other technical/scientific, or industry experience with sufficient exposure to pharmaceutical or related industries

• 5-7 years in the Pharmaceutical Industry and/or Government Regulatory Agency, including GXP Auditing experience and knowledge of GMP and ISO.

• Knowledge of Pharmaceutical Quality System

• Knowledge and understanding of the FDA, EU or other relevant GMP guidelines and

• ICH and other relevant technical guidelines

• Understanding of the WHO and other applicable regional and local regulations

• Good Communication skills

• Advanced written and verbal skills in Business English

• Awareness of intercultural differences

• Basic understanding of CFR part 11 and/or EU Volume 4, Annex 11

How do you apply?

If you are interested in this job and recognize yourself in the profile outlined, please express your interest via our website (http://abbott.jobs/) or by sending your application and CV to Talent Acquisition Specialist, Niels Dijkstra via recruitment.netherlands@abbott.com.

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 corpjat@abbott.com