Vp Of Clinical Quality Assurance

Job Description
AbbVie is dedicated to delivering a consistent stream of innovative, safe, and effective quality medicines and products that solve serious health issues and have a remarkable impact on people’s lives. As a quality organization in research &
development, R&
D Quality Assurance is committed to driving quality excellence across all stages of discovery and development for the product’s lifecycle to achieve product realization and accelerate access to innovative therapies and products for our patients.
Patient needs, stakeholder demands, industry innovation, regulatory landscape, and AbbVie’s evolved business strategy are complex, rapid pace, and dynamic. Emphasizing and embedding quality in the execution of clinical trials, assures patient safety, maintains data integrity, fosters regulatory compliance, and contributes to the overall success of drug/device development programs. An elevated, focused, and evolved Good Clinical Practices (GCP) strategy and pipeline partnership are essential. The Vice President Clinical Quality Assurance is a key role in R&
D, responsible for leading the Clinical Quality Assurance function and partnering with AbbVie’s R&
D Clinical Development organization to achieve consistent high-quality clinical research outcomes.
The VP Clinical Quality Assurance provides strategic leadership and direction for clinical quality assurance operations, ensuring compliance with regulatory standards and driving continuous improvement of Good Clinical Practices (GCPs). The role collaborates with R&
D clinical development senior leaders and stakeholders to develop, implement, and continuously improve global and local GCP quality strategies that align with AbbVie R&
D pipeline goals and objectives, setting the overall vision and long-term priorities for the Clinical Quality Assurance organization.
This role reports directly to the Vice President of R&
D Quality Assurance and is a member of the R&
D Quality Leadership Team. There is an expectation that in performance, leadership, and behaviors (AbbVie's Ways We Work), they serve as a role model to the organization at large.
Major Responsibilities:
Develop, implement, and ensure continuous improvement of the clinical quality assurance strategy ensuring compliance with applicable regulations, industry standards, and company polices.
Drive the strategic planning process for the Clinical Quality Assurance organization through ongoing assessment of regulatory, industry, technological, and internal trends/best practices, determining impact to the business.
Drive effective and efficient execution of clinical quality assurance projects/initiatives including associated activities stemming from new project acquisitions, collaborations, mergers/acquisitions, CAPAs, and continuous improvement efforts.
Pioneer industry leading clinical quality assurance techniques and approaches while maintaining compliance and efficiency in related operational processes. Develop strategies to identify and mitigate related risks across GCP activities.
Establish and maintain robust clinical quality standards. Develop and implement standard operating procedures (SOPs), quality manuals, and other related quality documents. Ensure that these systems are effectively communicated, understood, and followed by relevant stakeholders.
Develop and implement clinical quality risk management strategies to identify, assess, and mitigate risks associated with clinical operations. This involves conducting risk assessments, developing risk mitigation plans, and overseeing their implementation.
Consult and partner with the R&
D Quality Internal Auditteam to ensure appropriate focus areas of clinical operations, including investigator sites, vendors, and internal processes. Support regulatory inspections, ensuring preparedness and appropriate responses to findings and observations.
Provide leadership and oversight for training programs related to clinical quality assurance. Ensure that employees and relevant stakeholders receive appropriate training on quality standards, regulations, and procedures.
Evolve and chair the Clinical Quality Functional Area review to ensure the review meets its intended purpose and remains current with external/internal requirements including seamless integration with R&
D and Executive Management review.
Establish and monitor quality metrics and key performance indicators for the effectiveness of clinical quality assurance activities. Prepare regular reports and presentations for executive management highlighting quality performance, trends, and areas for improvement.
Collaborate with cross-functional teams, including clinical operations, regulatory affairs, pharmacovigilance, and other relevant departments, to ensure alignment and integration of clinical quality assurance activities. Build and maintain effective relationships with internal and external stakeholders, including regulatory agencies and auditors.
Drive a culture of continuous improvement in clinical quality assurance. Identify areas for enhancement, implement process improvements, and promote best practices to enhance an overall culture of quality, efficiency, and compliance.
Evolve, develop, lead, guide, and mentor a growing geographical dispersed clinical quality assurance team, responsible for the execution and sustainability of GCP across the R&
D clinical trial/study portfolio.Set clear expectations, manage performance, and foster a positive collaborative working environment for a geographically diverse team located around the world. Develop talent and build a skilled motivated team.
Significant Work Activities -Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)