Why Join Us?
Be a hero for our rare disease patients
Ultragenyx is a biopharmaceutical company committed to developing treatments for rare and ultra-rare diseases. Founded in 2010, the company has rapidly built a diverse portfolio of small molecule, monoclonal antibody, mRNA and gene therapy candidates with the potential to address debilitating genetic diseases for which the unmet medical need is high, the biology for treatment is clear, and for which there are no approved therapies.
Developing new treatments for rare genetic diseases is challenging work. It takes courage, talent, and dedication to look past the easy answers and uncover new solutions that can make a meaningful impact. At Ultragenyx we push each other to perform at our very best because we never lose sight of our mission – to make a difference in our patients’ lives.
Come join our team during this exciting time of growth and opportunities!
Position Summary
ultrainnovative – Tackle rare and dynamic challenges
Ultragenyx is undergoing an organizational transformation that requires efficient and effective formalization of risk management and continuous improvement processes in a highly regulated global workplace. Reporting to the Senior Director, Quality and Compliance, Ultragenyx is seeking a highly motivated and experienced Head of GxP Risk Management. This individual is responsible for the design, implementation, usability, and effectiveness of the Risk Management System. Position will be additionally responsible for the implementation and maintenance of a program that spans the functional spectrum of the organization and the lifecycle of the products.
Currently focused on Quality Risk Management, the Head of Risk Management will have the opportunity to provide the strategic direction and leadership of the risk management processes and tools across the greater organization. The position can be based in Novato or Brisbane, CA. This position requires up to 20% travel.
Responsibilities include, but not limited to:
- Implementation of risk management and continuous improvement programs (compliant with internal standards and ICH Q9) designed to efficiently and effectively identify, assess, score, and mediate risks
- Develop risk management toolkits, procedures, governance processes, and training materials
- Active collaboration with functional Subject Matter Experts in process and documentation development
- Proactively engage with both internal and external stakeholders, including health authorities and industry trade organizations
- Actively support inspection readiness activities and associated Health Authority Inspections relating to risk management approaches and processes
- Leverage external parties (e.g. consultants, suppliers, contractors, etc.) to execute robust and complex programs
- Provide skillset training in risk management processes such as FMEA.
Requirements:
- Bachelor’s Degree required in Biological Sciences, Chemistry, Engineering or related technical discipline, advanced degree or training in adult learning deployment is a plus
- Minimum of 10 years previous Quality Assurance experience at least 3 of which were focused in the area of Risk Management in the pharmaceutical, biotech or other related life-sciences industry; experience with Lean / Operational Excellence is a plus
- Experience with software related to risk management
- Able to design, implement and maintain compliant cross-functional Risk Management processes and tools
- Able to define and implement risk mediation measurements
- Proficient in Global cGMP’s and pharmaceutical industry practices
- Proficient in MS applications such as Power Point, Word, and Excel
- Strong influencing skills and creative problem solving capabilities
- Exceptional teamwork and collaboration skills with internal and external parties
- Must be able to proactively provide real-time resolutions and approaches balanced with long-term objectives
- Acts with a sense of urgency and be self-motivated with the ability to demonstrate initiative
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Ultragenyx Pharmaceutical Inc. is an equal opportunity employer. We understand that diversity of thought, culture and background will help us do the best for our patients. We prohibit unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status.
Note to External Recruiters: All candidate activity and open positions are managed strictly through our Human Resources Department. Our Human Resources Department kindly requests that recruiters not contact employees/hiring managers directly in an attempt to solicit business and present candidates. Please note that failure to comply with this request will be a factor in determining a professional relationship with our organization. Submission of unsolicited resumes prior to an agreement set in place between the Human Resources Department and the recruiting agency will not create any implied obligation. Inquiries on developing a recruiting relationship with us, may be directed to: talentacquisition@ultragenyx.com.
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