AbbVie Associate Director Quality Assurance, Combination Product & Medical Devices 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 as the Quality Assurance lead on R&D combination product / medical device development teams. Mentor/lead product team members through the design control process. Provide product QA support, reviews and approval for design control and risk management. Utilize quality engineering methods.
Provide QA support for new drug-device Combination Product development from late stage feasibility through transfer into commercial and/or clinical manufacturing operations
Perform and review/approve design control and risk management activities. Work closely with research and development organization to ensure potential product issues are identified and addressed in the design.
Work effectively and influence multiple functions (R&D, Operations, Commercial, Regulatory, Supply Chain, Medical etc.) to ensure design control expectations are met
Perform 3rd party management activities such as review of design control deliverables, assessment of supplier changes, supplier controls (corrective actions), quality agreements, relationship development, etc.
Ensure compliance with corporate and regulatory body requirements for medical devices and combination products.
Support resolution project team issues with minimal oversight
Work on complex technical problems, utilize quality engineering methods and provide innovative solutions
Interact with and have ability to influence decisions of R&D and Operations Directors and Vice Presidents. Requires high level of competence, confidence, and credibility.
Provide consultation and training on combination products and medical devices to internal and cross-functional groups
Lead quality system improvement initiatives
Assure integration of device, drug and biologic regulations into quality system
Represent the company as the combination products Quality Assurance subject matter expert during internal and external regulatory inspections.
Ensure design control documentation and requirements are met.
Bachelor’s degree is required; typically in sciences, engineering or other technical/scientific area
Master’s & above degree preferred. Engineering degree preferred
7-10 years of experience in Quality, Development or related field
Proven track record in successful execution of device development / design control and risk management in R&D; preferably in QA.
Device regulation (design control) experience required
Combination product and experience with supplier management preferred
Leadership of other technical professionals and experience in leading global cross-functional teams with results-orientation
Skilled in the initiation, selection, coordination and management of projects and have ability to resolve unusually complex technical problems by providing solutions that are highly innovative
Knowledge of regulations and standards affecting devices, biologics and pharmaceutical products
Knowledge of ISO standards, US Code of Federal regulations, and the EU regulations
Conflict resolution skills including persuasive management techniques required
Strong oral and written communication skills needed
Excellent interpersonal skills required
Makes critical, creative and strategic decisions as a result of rapid analysis of available information including risk-assessment for the patient and for the business
Must be able to respond quickly to unplanned events, technical issues and changing needs from development programs by making sound quality judgment from complied factual data provided by the different functional areas, each presenting varied viewpoint of regulatory requirements or project needs and requirements
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, 20 % 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.
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