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Lead Compliance Auditor

2 months ago


Westport, Connecticut, United States AbbVie Full time
Company Overview

AbbVie is dedicated to discovering and delivering groundbreaking medicines and solutions that tackle significant health challenges today while preparing for the medical hurdles of tomorrow.

Our commitment is to make a profound impact on the lives of individuals across various therapeutic domains, including immunology, oncology, neuroscience, and eye care, alongside our offerings in the Allergan Aesthetics portfolio.

For further details about AbbVie, please visit our website.

Position Overview

We are seeking a Senior Audit and Compliance Auditor (Quality) to enhance our operations in Ireland.

The ideal candidate will provide leadership and strategic direction, conducting evaluations to ensure adherence to both US and international regulatory standards. This role will involve a thorough assessment of quality-related systems across AbbVie’s internal manufacturing sites, affiliates, functional areas, and external suppliers.

Your expertise will be pivotal in assisting manufacturing sites with the resolution of regulatory challenges and supplier-related issues.

Key Responsibilities
  • Deliver leadership and guidance in evaluating compliance with US and international regulatory standards.
  • Conduct comprehensive assessments of quality systems for manufacturing sites, affiliates, and external suppliers providing materials and services to AbbVie.
  • Support AbbVie manufacturing sites in addressing regulatory challenges and supplier-related concerns.
  • Evaluate compliance of systems, facilities, and procedures in accordance with applicable regulations through audits and assessments.
  • Provide constructive feedback through audit observations, formulate actionable recommendations, and review corrective actions to ensure effective implementation.
  • Focus on AbbVie facilities and key suppliers with complex processes critical to business operations.
  • Lead or engage in technically intricate and strategic projects.
  • Participate in strategic initiatives aimed at enhancing compliance with regulatory standards.
  • Act as a subject matter expert in GMP requirements, emphasizing early detection and prevention of issues.
Qualifications

A Bachelor’s degree in a technical or scientific discipline (Chemistry, Pharmacy, Biology, Microbiology, or Engineering) or a minimum of 8 years of relevant industry experience in pharmaceutical, biotechnology, medical device, or combination product sectors.

A strong technical background with a comprehensive understanding of the audit process and extensive knowledge of global GMP regulations related to quality systems and compliance.

Familiarity with various quality and operational systems that support facility, product design, development, production, distribution, installation, support, and service, along with an understanding of quality management principles.

Excellent communication skills are essential, with the ability to collaborate effectively across divisions and technical areas.

A minimum of 6 years in quality assurance, with some management experience preferred, and at least 3 years in another function within the pharmaceutical, biotechnology, medical device, or related industry.

Experience in compliance, auditing, or regulatory affairs for 4 years is desirable.

ASQ certification is a plus.

Additional Information

AbbVie is an equal opportunity employer committed to integrity, innovation, and community service, while embracing diversity and inclusion.

We strive to employ qualified individuals of the highest caliber without discrimination based on race, color, religion, national origin, age, sex, physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, veteran status, or any other legally protected status.