AbbVie

Associate Director Quality Assurance, Combination Product & Medical Devices

Employer
AbbVie
Location
Lake County, IL, United States
Posted
Oct 26, 2020
Ref
2001690
Required Education
Bachelors Degree
Position Type
Full time
About AbbVie
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 , Facebook , Instagram , YouTube and LinkedIn .

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.

Responsibilities:
  • 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.


Qualifications
  • 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
Keyboard use (greater or equal to 50% of the workday)
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel
Yes, 20 % of the Time
Job Type
Experienced
Schedule
Full-time
Job Level Code
M
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.