New

Novato QC Project Management Specialist (Sr. Associate / Technical Manager)

BioMarin Pharmaceutical Inc.
life insurance, paid time off
United States, California, Novato
Jul 24, 2025
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. Novato QC Project Management Specialist (Sr. Associate / Technical Manager) The QC Project Management specialist is a leadership position in the Novato Quality Control team, reporting into the Head of Novato QC, focused on managing all projects for Novato Quality Control. The incumbent will develop a project intake process, assessment process of resources and prioritization, and work with the Novato QC Leadership Team (NQCLT) to ensure a robust project governance process and adherence to schedules. This role will work in collaboration with all teams within Novato Quality Control and will partner with stakeholders, such as Technical Development counterparts, Product Quality Leads, other teams within Novato and other testing sites, as required, to ensure on-time delivery of project work. Detailed Responsibilities: QC Project Management Create and maintain a robust project intake process that includes assessment of criticality and resource requirements. Create and maintain project governance and oversight in partnership with the NQCLT to ensure project visibility, status, and effective prioritization of resources. Leverage and improve existing tools for capacity planning for project work and ensure that risks are easily identified. Leverage and improve project management tools and timelines and provide active oversight of ongoing work, driving accountability across stakeholders. Create a project dashboard and integrate fully into the QC Risk log to ensure that risk mitigation is prioritized effectively. Partner with QC teams to ensure that progress is actively tracked, ensuring a robust escalation pathway to NQCLT for triaging and addressing issues with urgency. Manage and/or drive change controls for projects as required and ensure timely closure of all associated QMS records. Manage CAPAs as required in support of QC project work. Participate in / or author Quality Risk Assessments as required. Run workshops to engage QC teams in continuous improvement efforts, compiling continuous improvement ideas and projects and aiding in the prioritization of work. Implement and engage others in QC in lean tools across the QC organization. Aid in change management of new process improvements for QC and stakeholders, driving or developing training materials as required. Other duties as assigned. Required Skills Driving multiple complex projects and managing cross-functional teams to a shared end goal Influencing stakeholders to ensure timely completion of project work Proactively identify issues and ensure mitigation, with support from NQCLT as required Drive accountability with project owners and team members Familiarity with project management tools and Excel Familiarity with RCAR and lean tools to drive process improvements Strong OE mindset Ability to work on multiple, complex projects simultaneously Previous experience in a QC laboratory setting (pharma/biotech) Working knowledge of analytical methods, sample lifecycle, and lab workflows Familiarity with Binocs or similar scheduling tools is a plus Experience with Quality Systems (e.g., Veeva, CAPA, Change Control) EDUCATION BS with at least two years of Biotech experience. QC experience is preferred. SHIFT DETAILS Monday-Friday standard work hours ONSITE, REMOTE, OR FLEXIBLE Hybrid - would be onsite in Novato 3-4 days/week 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. The salary range for this position is: $91,200 to $125,400. BioMarin considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans. For additional benefits information, visit: https://careers.biomarin.com/benefits. Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.