Sr Manager QA - QVTS

Location: Northern

#
** SR MANAGER QA – QUALITY VALIDATION & TECHNICAL SERVICES**##
** What you will do
** Let’s do this. Let’s change the world. In this vital role you will lead activities associated with quality oversight of the design, installation, commissioning & qualification and process qualification of the new facility and equipment. You will collaborate cross-functionally through all stages (construction, facility start-up, operational readiness, operations) to ensure project timelines and landmarks are met. You will lend quality expertise and guidance to strategic and tactical decisions, ensuring both efficiency and compliance in business and operational processes.

This includes partnership with Manufacturing, Facilities & Engineering and other support functions providing coaching, guidance and direction on cGMP processes, procedures, protocols, assays, documents, records, quality systems, and compliance aspects.
* Ensure the design of the facilities and equipment, materials, organization, processes, procedures and products stay in sync with cGMP requirements and other applicable regulations.
* Provide quality and compliance expertise and agree on execution strategies related to the design, installation, commissioning & qualification and process qualification of the new facility, equipment, and information systems.
* Directly support and provide leadership for quality review and approval of documents to support facility commissioning and qualification, according to project timelines.
* Ensure the Quality unit provides review, approval and tracking of cGMP processes, procedures, protocols, assays, documents and records including but not limited to Work Orders, Deviations, CAPA's, and Change Controls.
* Ensures that all activities & related documentation for facilities, equipment, materials and processes align with applicable regulations and Amgen requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and Controls.
* Identify and drive implementation of continuous improvement opportunities.
* Collaborate cross functionally and across the Amgen Enterprise/Network to ensure the Quality Management System processes are implemented, maintained and carried out in accordance with established procedures and applicable regulations.
* Build and manage a strong team of Quality professionals that will partner effectively and provide quality oversight for the current and new facilities in the future.
* Ensures deviations from established procedures are investigated and documented per procedures
* Represent the quality unit during audits and inspections as needed.## ##
** What we expect of you
** We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a person with these qualifications.
*
* Basic Qualifications:

*** High school diploma / GED and 12 years Quality and/or Operations experience OR
* Associate’s degree and 10 years of Quality and/or Operations experience OR
* Bachelor’s degree and 8 years of Quality and/or Operations experience OR
* Master’s degree and 6 years of Quality and/or Operations experience OR
* Doctorate degree and 2 years of Quality and/or Operations experience
In addition to meeting at least one of the above requirements, you must have a minimum of 2 years’ experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources.  Your managerial experience may run concurrently with the required technical experience referenced above
*
* Preferred Qualifications:

*** 2+ years of management experience at a senior quality level.
* Experience in (or strong understanding of) biologics drug substance operations.
* Strong understanding of regulatory…