Description

Who We Are

BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health.

Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities.

Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best – people with the right technical expertise and a relentless drive to solve real problems – and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we’ve produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options.

About Technical Operations

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 ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients.

• Supporting the Quality Validation oversight of technical transfers and Commercial Readiness within Global External Operations (GEO).
• Supporting the Quality Systems program within External Quality ensuring key Quality System elements such as Deviations, CAPA’s, and Change Controls are consistently administered and in compliance with relevant Regulatory Standards
• Providing External Quality’s oversight of Contract MFG Organizations including process, packaging and shipping validation activities.
• Collaborating with BioMarin’s GEO MSAT, and Contract Manufacturing Organization (CMO) Operations functions to deliver and sustain compliant products and processes

• Perform the Quality Systems Metric Review for GEO and oversee relevant metrics and trending for each quality system within GEO to proactively drive on-time closure of Quality records.
• Responsible for managing routine cross-functional meetings to ensure timely closure of Deviations, CAPAs and Change Control, with leadership endorsement.
• Responsible for development/reporting of metrics and supporting standardization of these across the Organization.
• Co-ordinate monthly governance site quality review team (SQRT) meeting for GEO.
• Deliver training on Quality Management Systems within GEO, as required.
• Partner with the Global Quality Systems Management Team and other cross functional groups to ensure proper application of the QMS.
• Identify and implement continuous improvements initiatives to the External Quality systems.
• Participate in the change control program for modifications to qualified systems (within GEO).
• Assist as needed in audits and inspections.
• Participate in development and implementation of global alignment projects with BioMarin’s sister sites.
• Manage the Self Inspection Programme for External Quality
• Act as Quality support for Technology Transfers of BioMarin’s manufacturing processes to CMO’s focusing on establishing robust Quality Assurance control systems in partnership with the CMO’s to develop planned, predictable performance.
• Other duties as assigned

• Bachelor’s Degree in science or engineering
• Minimum 1+ years of biopharmaceutical experience in a Quality, Compliance, and/or Regulatory setting
• Skilled in data analysis and excel. Power bi experience desirable.
• Strong communication and interpersonal skills – Oral, written and presentation skills
• Works collaboratively with others to meet shared objectives.

Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.

Equal Opportunity Employer/Veterans/Disabled

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.