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

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 Manufacturing Quality Management System Review as well as establishing and executing site Annual Product Review (APR) programs. This position will be responsible for establishing

DESCRIPTION The Manager/Sr. Manager, CTO Quality Management & Operations, reports to Associate Director, CTO Quality Management & Operations and is responsible for the oversight of Contract Testing Organizations (CTO's) where the CTO performs testing of BioMarin Intermediates, Drug Substance/API and Drug Product. The Manager/Sr. Manager, CTO Quality Management & Operations

Description BioMarin is seeking a Director to lead the Product Quality Controls & Performance Systems (CPS) team. Reporting to the Head of Product Quality Lifecycle Management, this individual will be responsible to develop a high performing team driving the continuing development and implementation of key systems and controls that define, maintain, and identify opportunit

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

Coordinate commissioning and qualification activities involving cross functional, multi departmental teams Manufacturing, Process Sciences, Quality Control, Quality Assurance, Quality Validation, Capital Projects, Facilities, and various Engineering groups. Develop C&Q Project plans for large capital projects and review plans generated by contract staff. Develop scope of

The QC Analyst is responsible for performing environmental monitoring and microbiological test methods on in process intermediates and varying stages of drug products under minimal supervision and within cGMP guidelines, to support further manufacturing of commercial and clinical therapeutics. This role will involve knowledge that includes but is not limited to the follow

Strategy Single point of accountability for performance of managed service provider Collaborate with the Chief Procurement Officer and other leadership to align operational strategies with overall GSP goals. Design, develop and execute strategies that enable a world class procurement managed services function. Design, develop and execute process, data and technology strat

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

Counsel internal stakeholders regarding advertising and promotion, external communications, sales and marketing initiatives, FDA and OIG guidance, and industry codes (e.g. PhRMA) as they relate to business activities and communications with healthcare professionals, payors, patients, and/or patient advocacy organizations. Independently draft, review, and negotiate commerc