Clinical Process Compliance Manager I

United States
Nov 17, 2021
Required Education
Bachelors Degree
Position Type
Full time
About AbbVie
AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

The Clinical Process Compliance Manager will support the interpretation and application of GCP and regulatory principles (EU MDR, ISO 14155, CFR 812) into action in support of Development and business partners to drive execution of high-quality clinical trial conduct with minimal supervision.  Leads issue management activities for business partners demonstrating excellence in the identification, assessment and delivery of documentation of potential non-conformities, non-conformities, and oversight of effectivity checks with limited managerial oversight.  Demonstrates high degree of competence in delivering effective issue escalation and business continuity meetings. 


  • Partners with BPO, Functional and Development Leaders to support delivery of program, business process and functional compliance-related deliverables with minimal management oversight.
  • Partner with peers to share best practices and to align in delivery of strategic objectives.
  • Able to translates the vision, mission, and operational tactics of Clinical Compliance and apply them to functional deliverables, including but not limited to issue capture, assessment and documentation.
  • Oversees compliance metrics for assigned BPO and Function, and delivers on-time and comprehensive compliance metrics to support functional activities and overarching compliance metrics for Sr Leadership and business partners.  Using expertise to providing interpretation of possible signals or trends.
  • Drive meetings and discussions, managing delivery of actions to closure, and general oversight of the business continuity plan for Development Operations as it impacts areas or BPOs supported with minimal managerial oversight.
  • Represents Clinical Compliance in various initiatives within Development Operations or drives initiatives within Clinical Compliance.
  • Apply and lead discussions with business partners regarding application of Quality Manual principles in support of the ways we work.
  • Effectively manages, prioritizes and balances work activities for areas supported to effectively utilize resources to ensure business needs are met.
  • Reviews new and revised regulations, determining and interpreting content and implications with business partners to assess impact to clinical trial conduct and associated processes.  Drives discussions with business partners relative during procedural or process changes to ensure regulatory requirements are understood and maintained.
  • Delivers Development inspection support provided by Clinical Compliance (inspection support, response review and coordination, evidence review) with minimal oversight

  • BS or BA required; advanced degree preferred
  • Quality certification highly preferreduired
  • 6 +years’ experience in Pharma, Deviceor Related Field (e.g. Compliance or Quality leader)
  • Must have medical device experience and well-versed in EU MDR, ISO 14155, CFR 812
  • Demonstrates analytical and critical thinking skills. 
  • Possesses good communication skills and demonstrated leadership abilities and problem-solving skills
  • Able to translate strategy into operations and manage multiple changing priorities.

Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Yes, 10 % of the Time
Job Type
Job Level Code
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis 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, protected veteran status, or any other legally protected characteristic.