Sr. Coordinator, Quality

4 weeks ago

Novato, United States BioMarin Pharmaceutical Inc. Full time

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 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.

Senior Coordinator, Quality SUMMARY  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-paced environment that requires efficient and timely completion of duties.  This role also supports the Novato Site Head of quality in developing and managing visual displays, metrics pertinent Novato Quality.  This position requires critical thinking ability, influencing, collaboration, multi-tasking, independent execution, and leadership skills.     KEY RESPONSIBILITIES  -Develop and maintain visual displays for monitoring key performance indicators for Novato Quality Leadership team. -Manage department budget and associated processes.  -Assist NQLT in the creation and maintenance of RACIs and SLAs -Develop and implement NQLT sponsored projects and timelines. Serve as project manager as needed. -Create presentation slide decks as needed. -Attending NQLT staff meetings and serving as a scribe to capture decisions and action log.  Maintain NQLT action log. -Initiate and process MSA/NDA and SOW contracts in support of Global Quality Assurance, of Product Quality Lifecycle Management and Novato Site Quality Heads. Onboard New Suppliers in Coupa  -Proactively coordinate, create, and manage Novato site visit agenda and itinerary for the Chief Quality Officer (SVP)  -Create and maintain distribution lists for Novato Quality.  Develop a system for maintaining the lists current. -Perform other duties as assigned.   Experience: -Excellent interpersonal and communication skills (written & verbal) and ability to influence diverse stakeholders and drive accountability and decision-making cross functionally and at all levels. -Demonstrated ability to partner with other functional groups to achieve business objectives. -Demonstrated ability to work independently and effectively. -Demonstrated ability to drive continuous improvement and operating with a Lean and Agile mindset. -Experience in project management is a plus. -Ability to create slide presentations.  -Ability to work in a fast-paced environment.   -Results oriented; effectively manage multiple projects efficiently. -Demonstrated knowledge in data analytics and visual management tools required. -Proficiency in Microsoft office Suites required. -2+ years' experience in Biotechnology, Pharmaceutical or other regulatory industry preferred but not required.  Education: -BA/BS in life sciences or related field -Advance degree desirable, but not required.  Other: -This role requires being on site and 5 days/week. -Ability to travel domestically and internationally up to 30%  

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.

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