Product Complaint Manager

Employer
AbbVie
Location
Lake County, IL, US
Posted
Nov 27, 2018
Ref
1808652
Required Education
Bachelors Degree
Position Type
Full time
The R&D GMP Quality, Clinical Product Supplies, organization is responsible for Product Quality Assurance for investigational medicinal products (IMP), including both pharmaceutical drug and drug/device combination products. These activities comprise of disposition decisions for products, materials, protocols for clinical investigations, pilot plant and laboratory support for all Lake County R&D GMP facilities, and product complaint handling. In addition, the department has responsibility for corresponding satellite functions, currently located in Ludwigshafen, Germany. The basic functions are to assure that products (including API, drug product and finished packaging and labeled supplies) and data provided by the R&D organization are compliant with worldwide quality and regulatory requirements. The R&D GMP Quality, Clinical Product Supplies, organization has a prime opportunity for a Product Complaint Manager based in North Chicago, IL., reporting to the Assistant Director, Finishing QA.
Key Responsibilities Include:

  • SME of product complaint handling processes for R&D. Understand drug and device/combination product regulations.
  • Interface with external clinical investigators, drug depots/distributors, and partner companies to obtain complaint information.
  • Review adverse events for potential related product complaints. Ability to interpret medical terms contained in adverse event reports to evaluate potential linkage to product malfunction/issues.
  • Initiate new product complaint records in the electronic system, determine investigation needs based on complaint details, drive investigation activities, and document the final report.
  • Collaborate with equivalent role in Ludwigshafen R&D QA to ensure consistency and adequate support for all R&D product complaints.
  • Work closely with manufacturing and quality engineer personnel to perform complaint investigations and CAPAs, as necessary.
  • Assess risk/impact of complaints to clinical supplies.
  • Liase with Post Marketing Quality to assess reportability of complaints received for marketed products used in clinical studies to regulatory agencies.
  • Liase with safety organizations to ensure consistency of information between related product complaints and adverse events.
  • Perform complaint trending/tracking and present to management.
  • Maintain R&D standard operating procedures.
  • Interpret (new) regulatory requirements and support the implementation of compliant processes.
  • Provide consultation and training to internal and cross-functional groups.
  • Act as an advisor to management and customers.
  • Support regulatory inspections and internal audits.
  • Lead complex global cross-functional process improvement teams.


Basic:

Bachelor's degree or equivalent experience. 6-8 years of experience in cGMP related industry or in a clinical setting
Preferred:
• Bachelor's degree in nursing, pharmacy, medical technology, engineering or scientific background.

• Experience with device/combination product complaint handling

• Experience with reviewing/interpreting adverse event reports
Key AbbVie Competencies:

• Builds strong relationships with peers and cross functionally with partners outside of the team to enable higher performance.

• Learns fast, grasps the "essence" and can change the course quickly where indicated.

• Raises the bar and is never satisfied with the status quo.

• Creates a learning environment, open to suggestions and experimentation for improvement.

• Embraces the ideas of others, nurtures innovation and manages innovation to reality.

Equal Opportunity Employer Minorities/Women/Veterans/Disabled