Senior Audit and Compliance Auditor

2 weeks ago

Dublin, Ireland AbbVie Full time
Job Description

We are looking for a Senior Audit and Compliance Auditor to join our team in Ireland.  The successful candidate will provide leadership, direction and perform evaluation for compliance with US and foreign regulation requirements and provide relevant and constructive evaluation of quality related systems for internal AbbVie manufacturing sites, affiliates, functional areas and external suppliers. You will also provide support to the manufacturing sites in the resolution of regulatory issues and issues related to suppliers.

Your leadership, direction and execution in the area of GMP compliance and quality assures that activities are performed and documented in accordance with AbbVie policies/ procedures and applicable quality regulatory requirements to assure the quality, effectiveness and safety of our products.

Roles and Responsibilities

  • Provide leadership, direction on performing evaluations for compliance with US and foreign regulation requirements and provide relevant and constructive evaluation of quality related systems for manufacturing sites, affiliates, functional areas and external suppliers that provide material services and products to AbbVie.
  • Support AbbVie manufacturing sites in the resolution of regulatory issues and issues related to suppliers.
  • Assess compliance of systems, facilities, procedures per applicable regulations through audits and assessments, assuring compliance to regulatory requirements and AbbVie specifications.
  • Provide feedback in the form of audit observations, formulate recommendations, and review corrective actions to determine if corrective actions and commitments have been properly implemented and proven to be effective.
  • The major responsibilities of this position are primarily focused on AbbVie facilities and key suppliers whose processes are more complex, comprehensive and critical to the business.
  • Lead or participate in more technically complex and strategic projects.
  • The position serves a tactical purpose for AbbVie and must achieve a difficult balance of involvement, independence and objectivity.
  • Lead or participate in strategic initiatives to improve compliance to regulatory requirements and standards.
  • The position also provides an active role within the organisation as experts in GMP requirements. The strategic focus is for early detection and prevention, followed by correction of issues.

Qualifications

  • Bachelors degree preferably in a technical or scientific area (Chemistry, Pharmacy, Biology, Microbiology, or Engineering) or at least 8 years industry experience with sufficient exposure to pharmaceutical, biotechnology, medical device or, combination product related Industries.
  • Technical background with a thorough understanding of the Audit process and an extensive knowledge of worldwide requirements related to GMP regulations for quality systems and compliance.
  • Must understand a variety of quality / operational systems that support facility, product design, development, production, distribution, installation, support and service and understand the principles of quality management.
  • Persuasive, effective communication skills are essential with an ability to work effectively outside the company and across divisional and technical areas.
  • 6+ years in quality assurance with some management experience preferred and 3+ years in another function in the pharmaceutical, biotechnology, medical device or related industry.
  • 4 years in compliance ./ auditing or regulatory affairs is desirable.
  • ASQ certification desirable


Additional Information

AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion.  It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.

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