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Listed below are the top 10 out of 47 listings that are in the same industry and location as the job you were looking for. To see more than 10 listings, click here to search similar jobs in Thousand Oaks, CA
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For your reference, we have included the original job posting below.
Senior Manager QA - Product Complaints Process
Job Number:
38272125
Company Name:
Amgen
Job Location:
Thousand Oaks, CA US
Job Categories:
Engineering & Architecture Manufacturing & Production
Senior Manager QA - Product Complaints Process
The position will serve as the Complaints business process owner (BPO) with responsibility for the Product Complaints Process across Amgen. Responsibilities include global trending, adverse event and product complaint reconciliation, complaint risk matrix maintenance and management of Quality Management System process maturity. This position will own product complaint operating standards and global procedures and be the business owner of global technology tools that support the process. Responsibility also includes overseeing trending for site execution and adherence to process, timelines and interim reports of investigations, trending of cross product and cross site issues and maintaining current knowledge of industry standards and regulatory requirements related to product complaints.
This position will lead global product complaint forums, trending meetings and will serve as the back-up contact for Amgen Global Safety, regulatory and inspection interactions.
Other responsibilities may include: Interfacing with Senior Management, data management and presentation, leading process improvement and operational excellence initiatives
Basic Qualifications Doctorate degree & 2 years of experience directly related to the job OR Master's degree & 6 years of experience directly related to the job OR Bachelor's degree & 8 years of experience directly related to the job OR Associate's degree & 10 years of experience directly related to the job OR High school diploma / GED & 12 years of experience directly related to the job AND 2 Previous managerial experience directly managing people and/or experience leading teams, projects, programs or directing the allocation of resources
Preferred Qualifications Doctorate degree and 2 years of directly related experience
OR
Master's degree and 6 years of directly related experience
General knowledge of cGMP and filing regulations, practices, and trends pertaining to the manufacture, testing and distribution of biopharmaceuticals
Strong knowledge of U.S. and International regulations and practices pertaining to product complaint and adverse event reporting
