Technical Manager External Quality

Kentucky, United States of America

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The Position

This role provides quality oversight to the US Affiliate Complaint Management (ACM) product complaint (PC) process including PC record initiation and closure, reconciliation, and oversight of contracted call centers performing such activities on behalf of the US Affiliate Complaint Management Office.

Job Responsibilities

  • Product complaint record initiation and/or oversight
    • Oversight of contracted call center performing record intake
    • Manual initiation of records for exception processes (Lash, TeleRx, etc)
  • Product complaint closure oversight including final review of all US complaint investigations for accuracy and completeness according to established procedures.
    • Facilitation and prioritization of resources available for record closure.
  • Draft complaint closure letter to customers at close of investigation.
  • Initiation and reconciliation of Medical Product Complaints (MPCs)
  • Perform call center oversight and support in the form of training, documentation, process improvements, and issue resolution.
  • Perform and document various reconciliation efforts (PCs to AEs, AEs to PCs, etc).
  • Lead or support initiatives aimed at improving compliance, effectiveness, and efficiency of operations. Generate relevant metrics and KPIs.
  • Additional product complaint activities in support of the US ACM.

Job Requirements

List the minimal job requirements required for the job.

  • BA/BS in Life Science or equivalent experience
  • Minimum of 1-2 years in the pharmaceutical/biotechnology industry
  • Demonstrated knowledge and proficiency in complaint management processes and procedures
  • Ability to interpret and apply Quality standards
  • Ability to represent Quality processes during audits and inspections
  • Ability to build relationships with key stakeholders both in person and remotely
  • Strong communication skills, both verbal and written
  • Good judgment and decision-making skills
  • Travel as needed up to 15%

Who We Are

A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 40 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious illnesses. Please take this opportunity to learn about Genentech where we believe that our employees are our most important asset & are dedicated to remaining a great place to work.

The next step is yours. To apply today, click on the "Apply online" button.

Genentech is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status. For more information about equal employment opportunity, visit our Genentech Careers page.

At Genentech, we share salary ranges with applicants during the recruiting process, if requested. Third party salary estimates may not be accurate or up-to-date.

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