Manager Quality Assurance (IQA)

Career Category Quality Job Description Join Amgen's Mission to Serve Patients At Amgen, our shared mission to serve patients living with serious illnesses drives everything we do. Every team member plays an important role in helping advance science and deliver medicines that make a meaningful difference for patients around the world. Amgen fights the world's toughest diseases by harnessing the best of biology and technology. We draw on our scientific expertise to push beyond what is known today and help people live longer, fuller lives. If you are energized by collaboration, continuous learning, and meaningful work, we invite you to join our team and help make an impact. Manager Quality Assurance I What you will do The Incoming Material Manager Quality Assurance is responsible to lead IQA team which is part of the Lot Disposition group of the Quality Assurance function. The IQA team provides expertise in performing inspection, sampling and testing of incoming materials to meet Amgen specifications and ensure a constant supply of raw materials for ASM.  The team provides these crucial services to ensure only raw materials meeting Amgen specification and sourced from approved vendor are used to manufacture products for our patients. Main Responsibilities : Responsible for leading and directing IQA staff Responsible for providing Quality oversight to ensure material inspection, sampling and rapid ID testing performed in accordance to written SOPs, Methods, Good Manufacturing Practices (cGMP) and other applicable regulations Comply with safety guidelines and procedures Complete required assigned training prior to execution of required tasks Ensure Raw Materials inspection, sampling and rapid ID testing are documented in accordance with Good Documentation Practice Principle Ensure controlled documents for the area of responsibility that require periodic review have an active owner assigned Ensure document periodic review activities are completed on time for documents owned by assigned areas of responsibility Review records to ensure raw materials are tested and inspected according to specification and SOPs Perform business operations related to inspection/sampling/testing (i.e. updating dashboards, relevant metrics, housekeeping, inventory management, audit support) Support site/network Continual Improvement initiatives Ensures facilities, equipment, materials and procedures comply with cGMP practices and other applicable regulations Alert management of quality, compliance, supply and safety risks in a timely manner Performs review, approval and tracking of cGMP processes, procedures, documents and records, including but not limited to Nonconformances, CAPAs and Change Control records and Protocols.  May also support execution of these tasks Ensures that changes that could potentially impact product quality are assessed according to procedures Ensures that deviations from established procedures are investigated and documented per procedures Ensure no overdue Deviation and CAPAs Represents IQA function during audits and inspections as needed and ensure successful audit and Regulatory Inspections Conduct trouble shooting and problem solving related to systems and operations Conduct onboarding training to new hires Maintenance of IQA related equipment Performs additional duties as specified by management Provide coaching, guidance, talent development and performance review for IQA team What we expect of you Doctorate Degree Master’s degree and 2 years of experience in pharmaceutical company or GMP environment OR Bachelor’s degree and 4 years of experience in pharmaceutical company or GMP environment OR Diploma and 8 years of experience in pharmaceutical company or GMP environment At least 5 years of experience in Pharmaceutical Industry Experience and basic troubleshooting skills with laboratory and process equipment Experience with LIMS, SAP, TrackWise Ability to lead the team effectively and develop high performing team