AbbVie Senior Manager, Clinical Product Supplies (CMC) in North Chicago, Illinois
AbbVie’s mission is to discover and deliver innovative medicines 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, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on Twitter at https://twitter.com/abbvie , Facebook at https://www.facebook.com/AbbVieGlobal , Instagram , YouTube at https://www.youtube.com/user/AbbVie and LinkedIn at https://www.linkedin.com/company/abbvie .
Primarily responsible for ensuring the successful and timely release of GMP clinical supplies by providing direction and oversight of the overall manufacturing, testing and release processes from drug substance to drug product to finished product
Serve as the QA point of contact in CMC and Supply Chain meetings and direct QA functional areas to facilitate the approval of drug to clinical trials to meet project timelines
• Provide management of clinical supply product actions and recalls
• Support in-licensing and collaboration activities
• Ensure suitable quality agreements or quality aspects of contracts are in place between R&D and third party manufacturers, third party laboratories, other service providers and other sites
• Support the preparation of regulatory inspections and internal audits, and represents GMP Quality in inspections and audits
• Interact and influence decisions of the various R&D Directors and Vice Presidents as well as external customers and mentor Quality Engineers
• Provide consultation & training on QA specific items to internal and cross-functional groups
• Lead complex global cross-functional process improvement teams
• Work on unusually complex technical problems and provide solutions that are highly innovative and ingenious; resolve project team issues with minimal oversight
• Review and approve extemporaneous dose preparation instructions
• Bachelor's degree or equivalent experience is required; typically in life sciences, engineering
• Minimum 6+ years of industry experience in Quality Assurance, drug development or other healthcare related field; less experienced considered with advanced degree
• Broad understanding of pharmaceutical manufacturing processes (chemical and biological), analytical sciences, and worldwide requirements for GMP is required.
• Knowledge of regulatory compliance requirements should include historical perspectives and current trends of the regulatory agencies as they apply to the clinical pharmaceutical and chemical manufacturing processes.
• Good communications skills
• Must have leadership skills and have been seen to take a position on quality issues and standards, and must be capable of clearly and logically justifying such positions.
• Other competencies are required, e.g., making difficult decisions, relationship-building, influencing, fostering teamwork, knowledge of the business and sound judgment.
Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Keyboard use (greater or equal to 50% of the workday)
Yes, 10 % of the Time
Job Level Code
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis 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, protected veteran status, or any other legally protected characteristic.