Senior Manager, GCP Inspection Management (hybrid)

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 – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. 

This role is based onsite at our North Chicago, IL headquarters 3 days weekly.

Purpose:

Primarily responsible for managing GCP inspection activities to assure that R&D quality systems, , clinical and pre-clinical study conduct, personnel and records in support of worldwide regulatory filings are able to demonstrate compliance to policies, procedures and applicable government regulations

Responsibilities:

• Possess a working knowledge of GCP data collection systems like EDC, ePRO, IRT, eCOA and the corresponding regulatory requirements for these systems as it relates to system development, release and update, maintenance of appropriate clinical site user access reports and audit trail requirements.
• Act as the IM Liaison/partner with CDSO to advocate for expectations for health authorities and records needed to demonstrate clinical data integrity during inspections.
• Strategize fit-for-purpose inspection prep plans based on the drug, agency and previous inspection history.
• Mentor IM managers entering the department and/or GCP space.
• Coordinate IM resources, globally, for Clinical inspection preparation, conduct and response writing.
• Strategize corrective action plans and provide compliance support during implementation ensure successful inspections
• Effectively communicate risks to management, both orally and in writing
• Seek Intelligence from industry on global GCP inspections.  Represent AbbVie at AVOCA and other conferences

Qualifications:

• Bachelor’s degree, preferably in physical science (e.g. chemistry) life science (e.g. microbiology or biology), pharmacy, computer science. Strong technical background is required because the scope of the responsibilities is broad and requires the ability to communicate, understand and direct individuals in highly specialized technical fields
• Quality Assurance required.  Experience following areas highly preferred: Clinical Operations, Pharmacovigilance,
• Thorough understanding / knowledge of AbbVie GCP processes and regulations. Knowledge of pharmaceutical drug development and clinical research processes.
• Regulatory inspection experience preferably with direct agency inspector interaction
• Must have understanding and ability to anticipate and manage the sensitive nature of proprietary information.
• Strong project management skills are essential.
• Excellent oral and written communication skills required with the capability of clearly presenting and justifying quality requirements.

Key leadership competencies include cultural awareness, relationship building, ability to influence at all levels of the organization, teamwork building, sound judgment and the ability to make

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ​

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• 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 this posting 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 short-term incentive programs. ​​
• This job is eligible to participate in our long-term incentive programs. ​

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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 and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law. ​

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AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion.  It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because 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, status as a protected veteran, or any other legally protected group status.