Associate Director, RDQA US Clinical Audit

About AbbVie
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.

• Assures quality and compliance in a regulated environment including AbbVie policies and procedures and country specific and other applicable standards and worldwide regulations
• Contributes to the strategic direction of the Clinical Audit Team, ensuring alignment with RDQA policies and procedures.
• Advances the AbbVie Quality System through robust collaboration with business partners and other GxP RDQA functions and implementation of systems and processes required to support global quality assurance requirements
• Builds and leads high performing teams by creating an inclusive environment, focusing on people development, setting clear expectations, engages team members with clear vision on strategy and implementation.  Accountable to employees to coach for success in performance and Ways We Work (behaviours)
• Leads and delivers innovative quality strategies and solutions through collaboration with business partners and other GxP RDQA functions to support effective and timely solutions to compliance issues and/or questions.
• Drives development/continuous improvement of necessary quality and clinical systems by leading and/or supporting implementation of initiatives to assure compliance to regulations and corporate policies.
• Analyzes and evaluates processes that support clinical development in order to assure quality and compliance.
• Leads and develops a team of Clinical Auditors in the development and execution of all clinical audit types, performance and Ways We Work.
• Provides leadership and strategic insight to the risk-based clinical audit program, execute more complex audits and work with auditees to resolve any non-compliance(s) identified.
• Drives for results for self and staff by providing clear direction, establishing stretch goals/assignments and is able to communicate 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.
• Provides expert advice and support on clinical regulations, guidance and expectations to RDQA and business colleagues
• Promotes continuous education on quality and clinical guidelines and regulations for self and other AbbVie staff.

Qualifications

 

• Bachelor’s degree in science (physical, life, health), a health care profession (e.g., nursing or pharmacy) or equivalent experience
• 8+ years of experience in the pharmaceutical industry in the fields of clinical development, regulatory affairs and/or quality assurance supporting those areas.
• 5 years of experience in Quality Assurance.
• 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. 
• Strong analytical skills and the ability to organize work in a logical, thorough and succinct manner.
• Detailed knowledge of quality systems and auditing standards
• Extensive knowledge of worldwide clinical regulatory requirements and industry best practices.
• Ability to work in a fast paced and changing environment in an autonomous manner. Flexibility to adapt to changing assignments and ability to effectively prioritize.
• Ability to think strategically and communicate effectively with colleagues at all levels, including senior management. 
• Well-developed leadership competencies to deliver team objectives and projects.
• Willingness and ability to perform domestic and international travel

Significant Work Activities
Keyboard use (greater or equal to 50% of the workday)
Travel
Yes, 15 % of the Time
Job Type
Experienced
Schedule
Full-time
Job Level Code
M
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.