Hybrid Sr. Associate, Quality SAP, Quality Systems & Compliance at BioMarin Pharmaceutical Inc.

Description

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.

• Engage in project meetings to learn about system capabilities and processes, as well as provide input as a SME.
• Collaborate with stakeholders to define test scenarios, document results and Execute User Acceptance Testing (UAT).
• Support assessments to understand the impact of SAP implementation on current processes and systems.
• Serve as a Master Data subject matter expert, collaborating on data review, loading, migration, and maintenance of master data in the SAP system.
• Support review and approval of document revisions and applicable change controls.
• Participate in the cleansing and management of quality data to ensure accuracy and integrity in the new system.
• Collaborate cross-functionally to develop and execute a detailed site readiness plan to transition to SAP.
• Provide input to develop and implement plans to ensure business continuity during the transition.
• Communicate and share up-to-date information about the project with Quality Leadership.
• Participate in training activities to prepare to support end-user training and potentially co-facilitate training sessions. Support the use and learning of these materials.
• Serve as the first line of support for technical questions and troubleshooting within functional area.
• Drive knowledge management, sustainable knowledge transfer & management within function​
• Pre-Go-Live Activities: Before the system goes live, superusers help test and provide feedback on processes and systems, collaborate on training materials, and participate in data validation and other training activities.
• During Go-Live: They participate in Train-the-Trainer sessions, deliver training to users in their functional area, and provide on-the-ground, first-line support during go-live and escalate questions or concerns of peers as needed.
• Post-Go-Live Support: Superusers continue to provide support, gather feedback, drive continuous improvement, and address any issues that arise after the system goes live.
• Drive engagement and belonging activities at the Novato site in support of the Quality organization, leading teams as needed.
• Provide support to the Quality Leadership Team (QLT) on key initiatives.
• Other duties as assigned.

• Minimum of 5 years within the biotechnology or pharmaceutical industry.
• Strong knowledge of quality management systems 
• Extensive knowledge of GMP, FDA, EMA, and other regulatory requirements.
• Excellent written and verbal communication and interpersonal skills
• Must display strong analytical and critical thinking skills
• Demonstrated influencing, interpersonal and teamwork skills.
• Demonstrated ability to work independently, proactively identifying opportunities and taking actions
  
   

• BA/BS in life sciences or related field

• This role requires to be onsite two days a week. Additional days may be needed due to business needs (i.e. configuration, UAT, training, etc.)

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.

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.