Who We Are BioMarin's Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin's cutting edge manufacturing processes and sites, provide quality assurance and quality control to ensur

DESCRIPTION The Senior Technical Manager, Supplier Quality Management (SQM) will be responsible for owning and ensuring the quality and compliance of a category of supplier's within BioMarin's global supplier network. Emphasis will be on Single Use Technologies (SUTs) such as Filters, Bioprocess Containers, Reusable Tubing Assemblies, and some Consumables used in BioMarin'

Who We Are BioMarin's Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin's cutting edge manufacturing processes and sites, provide quality assurance and quality control to ensur

Lead and Support Possess a proven ability to lead and mentor investigators, fostering their professional growth and enhancing team performance. Spearhead comprehensive investigations and CAPAs, ensuring a sense of urgency, exemplary communication, and a focus on substantive content. Inspection Presentation Present investigation findings and Corrective and Preventive Actio

Department Leadership and Management Collaborate with QC Functional Head and People Department to identify needs and participate in recruiting, hiring, and promoting staff Lead and develop a cohesive, balanced, and high functioning team focused on producing high quality deliverables and outcomes Optimize the organizational design and allocation of team resources across th

The Senior Technical Manager is part of the Novato Quality Compliance group reporting to the Head of Compliance. The role is responsible and accountable for establishing and maintaining Novato's self inspection program for all GMP areas including clinical manufacturing and testing areas including network services that are managed out of the Novato site. This position will

Provide on the floor QA oversight and support to manufacturing operations Review executed batch records and associated document to ensure compliance with approved procedures and cGMP expectations Respond to quality related incidents or non conformances on the floor and secure necessary documentation for real time investigations Represent QA in support of deviations includ

Provide on the floor QA oversight and support to manufacturing operations Review executed batch records and associated document to ensure compliance with approved procedures and cGMP expectations Respond to quality related incidents or non conformances on the floor and secure necessary documentation for real time investigations Represent QA in support of deviations includ

ThisSenior Accounting Managerrole is part of theU.S.Controllershipteam, with a focus on the accounting for theWWRD (World wide Research and Development) function.This role will be reporting to the Director,U.S.Controllership, and be part of a great team who values flexibility, excellence, integrity, and work life balance. We are a global company with teams across the US,

ThisSenior Accountantrole is part of theU.S.Controllershipteam, with a focus on the accounting for theTechnical Operations (TOPS) function.This role will be reporting to the Director,U.S.Controllership, and be part of a great team who values flexibility, excellence, integrity, and work life balance. We are a global company with teams across the US, EUCAN, ICON, and other

This S enior Accountant role is part of the U . S . Controllership team , with a focus on the accounting for the WWRD (World wide Research and Development) function . This role will be reporting to the Director , U . S . Controllership , and be part of a great team who values flexibi lity, excellence, integrity, and work life balance. We are a global company with teams ac

This Manager Level role will support the execution of the WWRD GxP Audit Program with heightened focus in pharmacovigilance audit related responsibilities. Primary Responsibilities Participate in audit planning including internal or external audit risk assessment, audit scheduling, development of audit scope/agenda, and managing pre audit meetings Host and manage internal

The Head of Novato Quality Compliance is part of the Novato Quality Leadership team (NQLT), reporting to the Site Head of Quality and is accountable for all GMP compliance activities for the Novato Site and network services that are managed out of the Novato site. The Associate Director of compliance is a pivotal role in setting the GMP compliance tone for the Novato Site

The Senior Quality Coordinator is part of the Novato Quality Leadership Team (NQLT) reporting to the Head of Site Quality in Novato, California. The role is responsible for supporting MSA, NDA and SOW for the head of Global Quality Assurance, Novato Site Quality Head and Head of Product Quality Lifecycle Management Head. The Senior Quality Coordinator will work in a fast

DESCRIPTION The Manager/Sr. Manager, External Quality Planner reports to the Director of QA CMO Operations and is responsible for oversight of processes to ensure on time batch release for External Quality as per long range planning requirements. In addition, this role is responsible for alignment of Quality Capacity within the Supply Planning Cycle, including maintenance