Quality Manager, Monograph Donorship Program
- North Chicago, IL
- Permanent
- Full-time
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.