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.

QA Systems & Compliance

This position reports to the Associate Director, External Quality, Quality Systems, & Compliance. This role has four areas of responsibility:
• 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
• Supporting Continuous Improvement Governance and project implementation.
• Ensuring inspection readiness of the External Quality team and external partners.

Key Responsibilities for this Role as follows;
• Perform the Quality Systems Metric Review for External Quality and oversee relevant metrics and trending for each quality system 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 / External Quality.
• Deliver training on Quality Management Systems, 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 improvement initiatives to the External Quality systems.
• 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
• Other duties as assigned

The ideal candidate will have the following experience / skills:
• Bachelor’s Degree in science or engineering
• Minimum 3+ 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.