• Job Description

  Req#: R010518

  Job Summary

  The Quality Complaint Lead is a customer facing role that is responsible for the product quality compliant process and overseeing the distribution and completion of the quality complaint cycle which includes intaking of calls, dispatching questions to product quality experts and business partners and closing the communication process with customers for the NAM region.
  
  This role acts as a single point of contact between the customer and the business as it relates to quality product complaints. It will be critical in this role to have deep understanding of the business processes and maintain strong relationships with relevant business leaders as this role works with the US Production Units and Third-Party Manufacturing Quality Assurance groups to facilitate the completion of complaint investigations.
  Impacts all product quality complaints for the NAM region (products released to US market by the 3 NAM PUs and TPM Quality Assurance), which plays a role in ensuring the region’s GMP/FDA compliance status. It is essential that duties are performed promptly and accurately with special attention to each incident as the product’s safety, quality, identity, purity and potency could be impacted.
  
  Supervises the work of the Quality Complaint Coordinator(s) and performs Peer Review of their gCMW entries. The Quality Complaint Lead provides coaching, mentoring and training to Quality Complaint Coordinator (s) and is responsible for ensuring compliance with cGMP, SOP, and FDA regulations. Directly communicates with Fresenius Kabi customers in North America. This position has no direct reports.
  
  This position is not eligible for current or future visa sponsorship.

  Responsibilities

  • The Quality Complaint Lead monitors and manages the US complaints intake email inbox and 1-800 intake phone line:
  • Responsible for intaking of quality product complaint calls, dispatching questions to product quality experts and business partners and dispatching potential adverse drug reaction reports to Vigilance and potential medial inquires to MedInfo and closing the communication process with customers for the NAM region
  • Leads and owns the intake of product quality complaints and ensures that quality complaints are addressed promptly and handled accurately in accordance with SOPs and quality agreements.
  • Ensures timely initiation of product quality complaints in global complaint management system and performs peer review of Quality Complaint Coordinator entries.
  • Participates in creating and updating SOPs, work instructions and internal training guides, to establish consistency and efficiency.
  • Supervises and assigns the work of the Quality Complaint Coordinator(s) and performs Peer Review of their gCMW entries. Provides coaching, mentoring and training to Quality Complaint Coordinator (s) as needed.
  • Conducts training of Quality Complaint Coordinators on procedures for intake of complaints and forwarding of medical inquiries and adverse drug events.
  • Reports to management regularly on product complaints.
  • Evaluates current systems/processes against new product launches and new portfolios.
  • Works with cross functional teams to evaluate impact of new product launches.
  • Works with the Production Units and Third-Party Manufacturing Quality groups to ensure follow-up with the customer, aiding in the timely investigation of each complaint.
  • Works cross functionally in developing standard intake questions for certain products and complaint types.
  • Communicates with customers and documents all communication promptly and accurately.
  • Responsible for maintaining the historical and current files for all complaint intake related documents.
  • Ensures compliance to company documents, programs and activities related to Health, Safety, Environment, Energy, and Quality Management Systems as per roles and responsibilities.
  • Creates and sends letters to customers who have requested follow-up on their reported complaint(s).
  • May back-up Complaint Specialists and Senior Complaint Specialists including :
    • Authors complaint investigations related to third party manufactured product, in a timely manner.
    • Authors investigations for shipping complaints received for products distributed to the US market, in a timely manner.
    • Drafts initial and final impact assessments and reviews completed investigations by third party manufacturers.
    • Enters data and manages complaint records in KabiTrack and gCMW
    • Serves as back-up to Complaints Manager to run and distribute complaint due date reports (daily / weekly) for team, to drive prioritization of work.
    • Supports Complaints Manager with QA approval of KabiTrack and gCMW records

  Requirements

  • Bachelor’s Degree required (scientific discipline preferred).
  • 5+ years of complaint handling experience in pharma
  • Excellent communication, writing, and reasoning skills.
  • Experience with Microsoft Office programs is required.
  • Prior technical report writing experience and/or exposure to investigations and product quality complaints preferred.
  • Must be able to comprehend scientific/technical descriptions of analytical specification and methods, manufacturing controls and processes.
  • Must be able to recognize and resolve discrepancies and deficiencies.
  • Must be able to manage time effectively in a fast-paced pharmaceutical environment.
  • Must be able to effectively work with all levels of personnel within Fresenius Kabi and Fresenius Kabi partners.
  • Maintains a courteous, cheerful and cooperative demeanor at all times, with both internal and external customers.

  Additional Information

  We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company match, and wellness program.

  Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.

• About the company

  caring for life – Fresenius Kabi’s corporate philosophy. Find further information about our healthcare company here: ✓ Business Fields ✓ Career ✓ more

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