Director, Clinical Quality Assurance

About the role

The Director, Clinical Quality Assurance is responsible for developing and implementing global strategic quality oversight for Therapeutic Areas (TAs) within clinical development programs. This role ensures that R&D complies with corporate policies and worldwide regulations. This position provides strategic leadership, ensuring inspection readiness and delivering comprehensive QA perspectives for assigned TAs.

Responsibilities

• Delivers 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.
• Builds 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 our Development Programs early, prevent risks from impacting submissions and approvals, while increasing success during GCP inspections.
• Connects to Vendor QA and AREA QA, upholding the core principles of GCP across the matrix of QA teams supporting development. Engages across QAGxPs and delivers mitigation strategies to critical business partner networks.
• Develops a sustainable, collaborative relationship with clinical development leaders and organizations to ensure, promote, and guide that AbbVie quality systems, quality objectives, are understood and maintained to achieve AbbVie, R&D and RDQA goals.
• Drives 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.
• Analyzes and evaluates processes that support clinical development to assure quality and compliance. Leads and develops a team of Program Managers per assigned therapeutic areas in the development and execution of comprehensive quality assurance plans, performance, and Ways We Work Drives 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.
• Maintains two-way dialogue with others related to work assignments and results, brings out the best in people. Performs strategic planning to ensure resources are available for essential quality assurance activities.
• Provides leadership/collaboration in health authority inspections to assure success and supports resolution of findings by working with development business partners.
• Provides expert consultation and direction on complex quality assurance and GCP compliance inquiries from supported organizations.
• Promotes continuous education on quality assurance and GCP guidelines and regulations for self/direct reports and other AbbVie staff.

Qualifications

• 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.
• Buils 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 including 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. Bachelors degree in science (physical, life, health), a healthcare profession (e.g., nursing or pharmacy) or equivalent experience.
• Bachelors or Masters 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.