Quality Manager, Monograph Donorship Program

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 X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

Purpose
The Manager will be responsible for driving activities related to the planning and execution of AbbVie's Monograph Donorship Program. 

Responsibilities

• Lead the creation and alignment of the Monograph Donorship Long Range Plan.
• Manage the execution of the Monograph Donorship Long Range Plan, including the creation of monographs.
• Work cross-functionally to collate the required information for monograph creation from relevant functions.
• Develop monograph drafts.
• Serve as the primary point of contact for Monograph Donorship, both internally and externally (towards applicable pharmacopoeia).
• Lead cross functional team review and approval for monograph submission (e.g. operations leadership, legal, etc...).
• Lead quarterly Monograph Donorship Long Range Plan review meetings and present program status update to stakeholders and executive leadership.
• Establish and maintain the necessary process and work instruction procedures for the program.
• Manage the assessment and implementation of compendial changes according to official timelines.

• Bachelor’s Degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering, or other technical/scientific area.
• Minimum of 6 years in quality assurance and/or quality system oversight. 5+ years of experience with working and/or developing analytical methods in QC, S&T or R&D labs.
• In-depth knowledge and experience of compendia. 
• Excellent verbal and written communication skills, effective facilitation and collaboration with a cross-functional team.
• Experience working in a manufacturing sites preferred.
• Experienced in the use of standard software applications including Office 365.
• Strong interpersonal & communication skills.
• Proficient organization, planning, and project management skills.
• High level of competence, confidence, and credibility for interaction with senior and executive management.
• Demonstrate high level of independence, decision making, anticipate program scope and deliverable changes, and effectively communicate issues with management.

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 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. 

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:

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