Manager, QC Systems

Why Join Us?   Be a hero for our rare disease patients   At Ultragenyx, we fundamentally believe that taking real impactful action to care for the needs of patients and our people is always the right thing to do. To achieve this goal, our vision is to lead the future of rare disease medicine. For us, this means going where other biopharma companies won’t go – challenging the status quo and creating a new model that advances our field so more patients and caregivers can benefit from life-changing treatments. We do this by following the science, applying a novel rapid development approach, making innovative medicines at fair and reasonable prices, and creating a collaborative ecosystem to reach patients in ways that are most meaningful for them.    Our commitment and care for patients extends to our people, so culture is an essential cornerstone for Ultragenyx. We remain continuously focused on creating a supportive and inclusive environment of profound learning and growth – so employees can thrive in all areas of their lives, in and outside of work. Ultimately, we want to be an organization where we would be proud for our family, friends and children to work.   If you want to have a meaningful impact, do the best work of your career, and grow a lot, both professionally and personally, come join our team.

Position Summary:

This position is in the Ultragenyx Gene Therapy Quality Control Systems group. The primary functions of the Quality Control (QC) Manager will be to lead, own, and support Investigations/Quality Systems in support of Quality Control and manage key aspects of the analytical method lifecycle. The individual will operate as an independent contributor working collaboratively and closely with QC and QA peers to establish/maintain a high bar of quality mindset/quality culture within the Quality Control organization. 

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Work Model:

Core Lab & Ops: This role typically requires that the majority of the work be conducted on-site

Responsibilities:

• Lead and support complex technical investigations related to Quality Control (e.g. Out of Specification, Out of Expectation, Trend Investigations, etc.) 
• Manage key aspects of the analytical method lifecycle, including, but not limited to: 
  • Coordinate and author invalid trend reports
  • Coordinate the execution of annual analytical method performance trending reports
• Own and facilitate Change Control and CAPAs in support of Quality Control operations
• Provide coaching and training to junior analysts for deviations, root cause analysis, change control, and CAPAs 
• Support the establishment, tracking and communication of key performance indicators (KPIs) and other key operational metrics both internally to QC and to other UGT stakeholders within the organization
• Support a matrixed organization by cross training to support Quality Control enterprise systems (e.g. LabVantage LIMS and Learning Management System) as needed 
• Model leadership behaviors and mentor/train junior staff   

Requirements:

• Bachelor’s or Master’s degree in Biology, Chemistry or equivalent 
• Minimum 5-8 years of experience in the biotech industry 
• Demonstrated experience authoring and owning simple and complex Quality Systems (Deviation, Change Control and CAPA)
• Expertise in project management both individually and within teams is essential
• Demonstrated written and oral communication skills at individual, team and organizational levels
• Possesses strong time management skills 
• Experience working on cross-functional teams and managing relationships in collaborative, constructive manner with internal stakeholders required
• Independently motivated, detail oriented and strong problem-solving ability 

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  Full Time employees across the globe enjoy a range of benefits, including, but not limited to:   ·         Generous vacation time and public holidays observed by the company ·         Volunteer days ·