Associate Director, Clinical Quality Assurance

Company Description

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions 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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Job Description

The Associate Director, Clinical QA is responsible for developing and implementing a strategy for proactive quality oversight of clinical development programs within their responsibility.

This role will ensure that R&D remains in compliance with the corporate policies and applicable worldwide regulations. The role assures inspection readiness within the scope of a Clinical Development program/system. Provide consistent and aligned consultation to R&D team members from multi-functional interactions and delivering a comprehensive QA perspective. Influencing the decision-making process to ensure quality requirements are included within improvement initiatives.

This position is accountable to the Director of Clinical Quality, RDQA.  The decisions and recommendations made by the individual will directly impact adherence to applicable regulations, and thereby promote the continued success of R&D.

Responsibilities:

• Lead collaboration across TAs to ensure best practices and lessons learned are applied both within their area of responsibility as well as across TAs.
• Lead cross-functional projects and strategies that directly benefit the programs in their Therapeutic Area and identify when cross-TA opportunities can be implemented.
• Monitor new regulations and industry trends.  Ensure Compliance with Regulations and Policies within AbbVie and in partnership with external collaborations as applicable.
• Identify and manage support of issues within their programs and escalate as appropriate.
• Deliver program plans to support Inspection Ready development programs
• Coordinate internal and external compliance actions, assessments and audits that will impact their area and align support with Business Partners and QA partners
• Lead efforts to review critical clinical documents, development approaches and engage with strategic business partners in support of a proactive CQA team with actionable understanding of the assets
• Lead Risk Management principles and establish strong, sustainable connections across RDQA QA teams supporting assets in development, proactively engaging across RDQA, including by expanding connections to also include the business, to deliver effective mitigation strategies to critical business partner networks.
• Leverage their comprehensive understanding of the programs and upcoming development milestones to build quality into development programs early, prevent risks from impacting submissions and approvals, while increasing success during GCP inspections. 
• Proactively identify, monitor, and ultimately improve the CQA organization's connections and utilization of critical Quality System Elements, applying quality by design principles across Risk Management, Change Management, and Exception Management (inclusive of planned changes, issues, and exceptions).
• Engage stakeholders in on-going reviews of the activities, issues and achievements and build forums to ensure QA inclusion for process improvements and team awareness of proactive QA activities.

This role can be based in Lake County, IL/Irvine, CA/ South San Francisco, CA/ Worcester, MA / Maidenhead, UK/ Dublin, Ireland

Qualifications

• Bachelor’s degree in a physical science, life science, nursing, pharmacy or equivalent technical experience required.
  10+ years of pharmaceutical industry experience in any combination of quality assurance/regulatory affairs/clinical research development.
• Well-developed leadership skills
  Demonstrated application of critical thinking and the ability to independently develop and implement strategic quality solutions in support of clinical research development programs.
  The incumbent must be able to evaluate the quality of clinical operations outputs, perform assessments to identify potential gaps and recommend mitigations.
• The incumbent must be agile and able to respond rapidly to unplanned events, changing needs of development programs as well as changing regulatory requirements and