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