Senior Director, Quality Systems & Support Services
AbbVie’s mission is to discover and deliver innovative medicines 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: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
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. AbbVie's quality foundation resides in the Quality Policy and Quality System, an integrated model in which AbbVie systematically defines quality objectives, both strategic and applicable regulatory requirements. AbbVie's One Quality System is divided into six Quality System Elements: Management Responsibilities, Process Performance & Product Quality, Corrective and Preventive Action, Change Management, Documentation, and Risk Management.
Advancing the AbbVie Quality System in R&D is the Quality System and Support Services (QSSS) organization's responsibility. This is accomplished by ensuring innovative, adaptive, effective, and fit-for-purpose solutions that can be transformational and drive quality excellence in R&D as a strategic advantage and accelerate access to innovative therapies for waiting patients.
Included with QSSS are support services functions of global Qualification & Validation, Quality Knowledge Management, Documentation Standards, Training, and Quality Data Analytics.
Incumbent of this role is a member of the R&D Quality Assurance (RDQA) Leadership Team (LT) and reports directly to the Vice President, R&D Quality Assurance. As a member of the RDQA LT and Head QSSS, 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.
- Accountability and direction for developing, deploying, managing, and continuously improving the AbbVie Quality System in R&D, an organization of approximately 12,000 employees. Ensures the AbbVie Quality Policy objectives are achieved by committing to quality and continuing effectiveness of the Quality System (QS).
- Drive continuous improvement and strategic initiatives for quality in RDQA and R&D, specifically Quality System Excellence (QSE) for R&D. Ensures targets and outcomes are met by R&D functions.
- Directs in strategy and tactics, a team of process owners responsible for policy/process for elements of AbbVie's Quality System and associated services.
- Oversees quarterly reporting from generation, analysis, and reporting of the organization's quality health along with quality metrics and remediation should it exist.
- Provide leadership, strategic direction, and growth and development of professional staff located in multiple countries to ensure that quality principles and practices comply with global regulatory requirements.
- Develop Key Performance Indicators (leading and lagging indicators) to measure compliance and quality and drive improvements with RDQA Senior Leadership.
- Ensure alignment with and provide input into AbbVie quality policies and processes, as well as ensuring that practices align with other Functional processes, especially with integration, alignment, and optimization with Allergan.
- Drive innovation and the power of data analytics and predictive analytics as new methods of ensuring quality data and first pass approvals.
- Provide expert input, advice, and counsel to business partners to master evolving regulations and regulatory expectations, and in partnership with the businesses, ensure implementation of compliant quality processes.
- Continuously evaluate quality processes to ensure that AbbVie R&D is in compliance with AbbVie quality policies and procedures, with country-specific and other applicable standards and global regulations.
- Develop and implement systems, technology, and processes required to support global processes and quality assurance requirements, including continuous improvement processes.
- Represent AbbVie at industry conferences/forums to advocate for AbbVie's position on evolving and emerging regulations.
- Define and execute goals per RA/RDQA goal framework and functional priorities in alignment with R&D Functional Priorities.
- Bachelor's degree required, preferably in Life Sciences, Pharmacy, Engineering, Nursing, or other medical science degree combined with equivalent technical experience. Masters / Ph.D. is desirable but not essential.
- 15+ years industry experience in any combination of pharmaceutical, device, combo/device, research, development, clinical research, pharmaceutical manufacturing, quality management systems, or a combination of those or comparable experiences.
- Understanding of international GXP regulations, pharmaceutical drug/device/combo-device development, and clinical research processes.
- Deep expertise in quality management principles, application, and implementation of Quality Management Systems, Quality Risk Management, Change Management, and Quality by Design.
- Lean Six Sigma Black Belt preferred or proven success with outcomes of improvement initiatives.
- Well-developed leadership competencies including motivation, cultural awareness, active engagement, relationship building, sound judgment, and the management of sensitive proprietary information.
- 10+ years in the successful management of employees, including large groups where management of people managers and directors has been successful. 5+ years in a Quality Assurance environment
- 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.
- Identify key talent and create an environment that motivates all to high performance. Experience in conducting yearly performance reviews with candid feedback and ongoing coaching throughout the year.
- Strong, strategic, creative, and "big picture" thinker, considered a visionary. Proactive leader with well-developed management skills and the ability to anticipate and identify potential issues to address early to mitigate or prevent. Demonstrated executive presence. Ability to make difficult decisions under pressure.
- Ability to direct and coach all aspects of QS work projects effectively within evolving and at times rapidly changing priorities and deadlines.
- Ability to direct and coach to prioritize and balance multiple tasks simultaneously to achieve goals and satisfy internal stakeholders.
- Evaluates performance, ability to differentiate various performance levels, and assists in career development planning for employees within responsibility.
Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Yes, 15 % of the Time
Job Level Code
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.