Director, Risk Management - Brisbane, CA | Biospace
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Director, Risk Management

Ultragenyx Pharmaceutical Inc.

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Location:
Brisbane, CA
Posted Date:
7/20/2017
Position Type:
Full time
Job Code:
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Director, Quality,

Job Description

Why Join Us?

Ultragenyx is a clinical stage biotechnology company committed to bringing to market novel products for the treatment of rare and ultra-rare diseases with an initial focus on serious debilitating metabolic genetic diseases. Founded in 2010, the company has rapidly built a diverse portfolio of both large and small molecule candidates with the potential to address diseases for which the unmet medical need is high, the biology for treatment is clear, and for which there are no approved therapies.

Come join our team during this exciting time of growth and opportunities!

We are located in Novato, CA, 25 miles north of San Francisco with additional office space in Brisbane, California and Basel Switzerland.

Position Summary:

Ultragenyx is undergoing an organizational transformation that requires efficient and effective formalization of risk management processes in a highly regulated global workplace. Reporting to the Vice President of Quality Systems, Ultragenyx is seeking a highly motivated and experienced Head of 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 life cycle 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 but weekly time shared in both locations is required.  This position requires up to 10% travel.

Responsibilities, including but not limited to:

•   Implementation of risk management programs (compliant with internal standards and ICH Q9) designed to efficiently and effectively identify, assess, score, and mediate risks
•   Develop risk management tool kits, 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 skill set 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 15 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

Ultragenyx Pharmaceutical is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status.