Director, Clinical Quality Assurance

About This Role

This role involves developing and implementing global strategic quality oversight for Therapeutic Areas within clinical development programs. The Director, Clinical Quality Assurance ensures R&D compliance with corporate policies and worldwide regulations, providing strategic leadership, inspection readiness, and comprehensive QA perspectives for assigned TAs. This position focuses on proactive quality to support global Clinical Development, ensuring quality excellence, data integrity, and the realization of R&D goals.

Responsibilities

• Deliver innovative quality strategies and solutions through collaboration within RDQA and R&D personnel, all levels of AbbVie management, other GxP functions, and external service providers to support effective and timely solutions/responses to compliance issues/questions
• Build a strategic, high-performing team within the TAs that can leverage their comprehensive understanding of the TA, 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
• Connect to Vendor QA and AREA QA upholding the core principles of GCP across the matrix of QA teams supporting development
• Engage across QA GxPs and deliver mitigation strategies to critical business partner networks
• Develop a sustainable, collaborative relationship with clinical development leaders and organizations to ensure, promote, and guide that AbbVie quality systems and objectives are understood and maintained
• Drive development/continuous improvement and implementation of necessary GCP systems by leading and/or collaborating on implementation of cross-functional initiatives to assure compliance to regulations and corporate policies
• Analyze and evaluate processes that support clinical development to assure quality and compliance
• Lead and develop a team of Program Managers per assigned therapeutic areas in the development and execution of comprehensive quality assurance plans, performance, and Ways We Work
• Drive for results for self and staff by providing clear direction, establishing stretch goals/assignments and communicating expectations and objectives in a clear and well-planned manner
• Maintain two-way dialogue with others related to work assignments and results, bringing out the best in people
• Perform strategic planning to ensure resources are available for essential quality assurance activities
• Provide leadership/collaboration in health authority inspections to assure success and support resolution of findings by working with development business partners
• Provide expert consultation and direction on complex quality assurance and GCP compliance inquiries from supported organizations
• Promote continuous education on quality assurance and GCP guidelines and regulations for self/direct reports and other AbbVie staff

Requirements

• Strong analytical skills and the ability to organize work in a logical, thorough, and succinct manner
• Ability to work at an experienced level, demonstrating effective leadership in interactions with business partners at all levels
• Steps up and takes leadership to own toughest challenges, persisting to achieve the right results for the organization
• Motivates and can influence others, including those over whom they have no direct authority
• Professional, accountable, energetic, and collaborative team player
• Ability to advance relationships within function and business partners
• Thorough knowledge of quality systems, auditing standards, and quality management processes
• Advanced business acumen, understands complexities of organizational design, working knowledge of current and future practices
• Extensive knowledge of worldwide regulatory requirements and industry best practices that govern clinical development
• Ability to work in a fast-paced, high-pressure, and changing environment in an autonomous manner
• Flexibility to adapt to changing conditions and ability to effectively prioritize
• Grasps the “essence” and can change course quickly, where indicated
• Project management, interpersonal, and communication skills with the ability to influence
• Builds strong teams and relationships with peers and cross-functionally at both global and local levels to drive performance
• Excellent communication skills, including superior negotiation and influencing skills
• Acute listening skills to gain understanding or to solve a problem and the ability to recognize the difference
• Ability to manage difficult conversations and seek alignment
• Ability to motivate and develop high-performing teams with challenging goals that bring growth and development
• Well-developed leadership competencies include motivation, cultural awareness, active engagement, relationship building, sound judgment, and the management of sensitive proprietary information
• Ability to direct and coach to prioritize and balance multiple tasks simultaneously to achieve goals and satisfy internal stakeholders
• Extensive knowledge of clinical development for biopharmaceuticals
• Bachelor’s degree in science (physical, life, health), a health care profession (e.g., nursing or pharmacy) or equivalent experience
• Bachelor’s or Master’s Degree or equivalent education with typically 12+ years in the function or closely related field
• Biopharmaceutical industry experience in quality assurance, compliance and/or other related development functions that includes 5 years in leadership positions (people and/or initiatives/projects)
• Ability to travel (on average 10-20%) including willingness and ability to perform international travel

Benefits

• Comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees
• Eligible to participate in short-term incentive programs

Important Details

• Locations: Lake County, IL; Irvine, CA; EU; UK

About the Company

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. They strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in their Allergan Aesthetics portfolio. ``