Associate Director, Product Quality

Lake County, IL, US
Jul 16, 2019
Required Education
Bachelors Degree
Position Type
Full time
The Associate Director, Product Quality is responsible for:
  • Driving life cycle management of Medical Devices and Combination Products (New Product Introduction & On-Market Support).
  • Leverage molding technology / device experience in order to act as molding / assembly of molded components quality SME for internal AbbVie and external key stake holders.
  • Responsible for quality of assigned molded components to ensure business objectives are met with regards to on time delivery of molded components and /or assembly of molded components while assuring compliance to local, divisional, and corporate policies and external agency regulations worldwide.
  • Manage quality relationship with assigned molded component suppliers to ensure compliance with AbbVie requirements, adherence to applicable regulations and utilization of industry best practices for molding operation.

Key Responsibilities Include:
  • Drive Lifecycle Management of Medical Devices and combination products through new product introduction and on market support. Support design changes to existing medical devices and combination products. Understand sources of engineering and sustain engineering.
  • Leverage platform technology to understand design space and relationships that design outputs and environmental factors have on the design space (design and process).
  • Utilize risk management and failure analysis proactively to anticipate events and implement mitigation.
  • Work with external and internal partners to establish best in class practices for injection devices and other assigned molded critical components, devices, biologics or combination products.
  • Participates in the development of global Quality Assurance strategy to support pharmaceuticals, biologics, device and combination products produced at AbbVie plants as well as third party manufacturing (TPM) facilities. Implements agreed strategy.
  • Makes recommendations for key decisions on product quality and compliance and regulatory conformance issues for sterile, biological, liquid, solids, and/or device products / critical molded components and elevates medium and high risk events to AbbVie management.
  • Ensures alignment of Quality and Technical Agreements with the legal contracts and that the commitments of the quality and technical agreements are being fulfilled. Helps facilitate resolution in cases where they are not.
  • Establishes and maintains relationships and open communication with Medical Device suppliers, Molded Component Suppliers, AbbVie plants, Affiliates and other functional groups to maintain roles and responsibilities, identify potential projects and issues, obtain an in-depth understanding of the quality, compliance, and resource needs at each site and provide guidance on quality concerns.
  • Perform base business quality assurance activities for assigned products and suppliers, including supplier management, product annual review, design transfer, design verification/validation, change control, complaint trend investigation and exception reporting.
  • Completes management reviews with assigned Medical Device and Molded Component Suppliers that identify and address quality, operational, and organizational issues and track supplier performance metrics to ensure accuracy, completeness, timeliness, and trends are identified and addressed in an appropriate manner.
  • Provides quality oversight and support for both external and internal assembly operations utilizing critical molded components. Assists in resolving quality issues pertaining to molded components used in assembly .

Grade is commensurate on level of overall responsibility.

Basic Qualifications:
  • Bachelor's Degree in Life Science or other technical discipline. Graduate degree desired.
  • 10+ years of total combined experience. At least 7 years of experience in Quality Assurance Operations Management; 4 years in Operations, Research and Development or Consulting.
  • Knowledge and a comprehensive understanding of biological and/or pharmaceutical technologies (sterile, biological, liquid, ointments, devices, solid tablets and caplets, suspensions, granulations, soft elastic capsules, gel caps, extended release products, coating solutions and/or active pharmaceutical ingredients).
  • Possesses knowledge and skill set to operate within an environment that requires a high degree of urgency, strong analytical and problem solving skills, positive interpersonal skills, ability to manage multiple complex tasks simultaneously, and capable of performing as leaders, members, and individuals

Key Stakeholders:

External Manufacturing Business Relationships, Operations, Third Party Manufacturers Business Alliance, Operations or Commercial Brand Teams, Commercial, Global Supply Chain, Domestic and International AbbVie Plants and Affiliates, Regulatory Affairs.

Equal Opportunity Employer Minorities/Women/Veterans/Disabled