Quality Manager, Monograph Donorship Program

Company Description

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.

Job Description

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.

Qualifications

• 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