Company Description
About AbbVie
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. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.
Job Description
* This role could be based in any of our hub locations (North Chicago, IL/Cambridge, MA/Worcester, MA/Florham, NJ/Irvine, CA/San Francisco, CA) in US
Purpose:
As the Head of the Americas Clinical Quality Audit team, leads a high performing team to deliver on the Clinical Audit strategy and assure the quality and compliance of AbbVie clinical trials and studies in the region.
- Assures quality and compliance in a regulated environment including AbbVie policies and procedures, country specific requirements, 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.
Responsibilities:
- Leads and develops a team of Clinical Auditors, based in the Americas, in the development and execution of all clinical audit types. Build a strategic, high-performing team that operates cross functionally to build-in quality to AbbVie processes from the outset.
- As part of the Clinical Audit Leadership Team, contributes to the development of the global Clinical Audit strategy while driving this at an Americas level.
- 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.
- 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.
- Analyses and evaluates processes that support clinical development in order to assure quality and compliance.
- 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.
- Provide strategic input to the inspection support model and actively support GCP inspections onsite or remotely if needed
- 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
- 7+ years of experience in the pharmaceutical industry in the fields of clinical development, clinical trials regulatory affairs and/or quality assurance supporting those areas, or with a regulatory authority.
- Detailed knowledge of quality systems and auditing standards.
- Extensive knowledge of worldwide clinical regulatory requirements and industry best practices, quality management principles, including global and regional regulations and internationally recognized standards (e.g. ICH, ISO).
- 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 manage complex issues and distil information. Strong analytical skills and the ability to proactively identify, rapidly assess, and effectively manage business and compliance risks.
- Significant experience leading cross-functional and multi-location teams through complex projects with demonstrated 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
Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of thisposting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location,and we may ultimately pay more or less than the posted range. This range may be modified in the future.
We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
This job is eligible to participate in our long-term incentive programs.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission,incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless anduntil paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html