Director of Regulatory Compliance

4 days ago


Chicago, Illinois, United States AbbVie Full time

Job Description

We are seeking a highly experienced Safety and Quality Assurance Leader to join our team at AbbVie. In this role, you will be responsible for leading the management of a global QA team providing independent quality oversight of GxP activities across the AbbVie drug, device, and cosmetic portfolio.

You will oversee the generation and assessment of current/new safety, regulatory, and medical affairs policies and procedures to ensure they meet and/or exceed expectations. As a thought leader/expert in R&D Quality Assurance strategic process updates, you will proactively assess evolving regulatory changes and generate new approaches to advance quality assurance excellence mindset.

The ideal candidate will have a Bachelor's degree in Life Sciences, Biology, Nursing, Pharmacy, or other science-based degree, with a minimum of 10 years of pharmaceutical experience, including substantial progressive leadership positions in quality and/or compliance. Proven leadership skills with direct reporting and matrixed environments are required.

Key Responsibilities:

  • Lead, develop, and implement routine and QA oversight strategies relating to R&D business stakeholders, including Pharmacovigilance and Patient Safety, Regulatory Affairs, and Medical Affairs.
  • Implement process to lead gap assessments of draft and final regulatory intelligence against internal core requirements and SOPs.
  • Oversee the development/implementation of safety, regulatory, and medical affairs corporate and/or organizational policies/procedures.
  • Review escalation issues to proactively identify emerging trends and develop appropriate action plans.

Required Qualifications:

  • Bachelor's degree in Life Sciences, Biology, Nursing, Pharmacy, or other science-based degree.
  • Minimum 10 years of pharmaceutical experience, including substantial progressive leadership positions in quality and/or compliance.
  • Proven leadership skills with direct reporting and matrixed environments.

Benefits:

  • Estimated salary: $120,000 - $180,000 per year.
  • Comprehensive benefits package, including paid time off, medical/dental/vision insurance, and 401(k) eligibility.
  • Short-term and long-term incentive programs.

About AbbVie:

AbbVie is an equal opportunity employer committed to operating with integrity, driving innovation, transforming lives, serving our community, and embracing diversity and inclusion.



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