Product Quality Complaint Manager

Date: Sep 11, 2022

Location: US-NJ-Bridgewater, New Jersey, US

Company: Bausch Health

Position summary:

Oversees complaint management for External Manufacturing Quality Assurance.

Identify and implement effective quality systems to oversee the complaint management process.

Manager of Product Complaints will work directly with Bausch Health External Manufacturing suppliers to provide sustaining quality and compliance leadership as well as routine support related to commercialized products. Responsible for field alert reporting and recall activities for US EMQA

Assist the site quality leader in developing an engaged team with expertise and skill sets to advance ‘Quality First’ culture. Support audits from quality related regulatory agencies and notified bodies.

Provides direction and coordination of quality activities utilizing continuous quality improvement principles and methodologies.

 

Key responsibilities:

  • Oversee complaint management process in compliance with directives/country regulations, process improvements, metric tracking, and risk mitigation activities.
  • Manages the Complaint Review Board to review complaint trending with a cross functional team.
  • Escalates issues related to complaint trends, nonconforming product, etc.  Drives CAPAs related to complaints.
  • Leads Field alert report process and recalls for US market.
  • Sponsor and/or lead quality improvement activities.
  • Support North America supplier management team in identifying opportunities for improvements. Responsible for overseeing NC/CAPAs related to finished good/external manufacturing suppliers and Bridgewater site within required timelines.
  • Proactively investigate, identify, and implement best in class quality practices.

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Qualifications/experience:

  • Education: Bachelor’s or Master’s degree in Chemistry, Chemical Engineering, Microbiology, or a related science.
  • A minimum of 8 years’ experience in pharmaceuticals and/or medical devices, with a minimum of 5 years in complaint management.  Experience in leading teams.
  • Knowledge of 21 CFR 210, 211, 820, and ISO 13485. Working knowledge of FDA/other country regulations and experience with interacting with external agency audits necessary.
  • Good organizational skills a must. Effective communication skills needed to provide clear and concise information to team members.
  • Technology Skills: Windows, MS Word, MS Excel, Database Management. 
  • ASQ certification preferred but not required.
  • Training in problem solving tools is required (ex: Process Mapping, Histograms, FMEA, Risk Assessment, Cause & Effect Diagrams, PCDA, Pareto Analysis).