Regulatory Compliance Manager

5 days ago


North Chicago, Illinois, United States AbbVie Full time

About Us

AbbVie is a global leader in developing and marketing innovative pharmaceuticals. Our commitment to research and development has led to breakthrough treatments in a range of therapeutic areas, including immunology, oncology, neuroscience, and eye care.

Job Description

We are seeking an experienced Manager to lead our validation quality systems team. The ideal candidate will have a strong background in quality assurance, regulatory compliance, and leadership. Key responsibilities include providing quality assurance support, implementing and maintaining effective validation quality systems, and ensuring compliance with corporate policies and regulations.

Key Responsibilities

The key responsibilities of this role include:

  • Providing quality assurance support to pharmaceutical products, cosmetics, and biologics
  • Implementing and maintaining the effectiveness of the validation quality system in compliance with Corporate policies, processes, and procedures
  • Designing effective quality systems, procedures, and/or processes within cross-functional teams to ensure compliance and efficiency throughout our quality system
  • Preparing and presenting validation data for management or during regulatory audits (FDA, EMA, Anvisa, etc.) and internal audits
  • Managing and overseeing a group of validation engineers

Requirements

To succeed in this role, you will need to have:

  • Bachelor's degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering, or a related field
  • 8+ years of experience in quality assurance, quality oversight, or a related field
  • Leadership experience, including managing technical professionals and leading cross-functional teams
  • Technical knowledge in Validation, including Equipment Qualification, Process and Cleaning Validation
  • Manufacturing Operations knowledge and familiarity with product, process, equipment, and facilities of pharmaceutical and biological related products
  • Knowledge of QA systems and GMP compliance requirements, including regulations and standards affecting biologics, and pharmaceutical products
  • Excellent oral and written communication skills, as well as strong interpersonal skills

Benefits

AbbVie offers a comprehensive benefits package, including paid time off, medical/dental/vision insurance, 401(k) plan, and short-term/long-term incentive programs.



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