EU QP, CMC Quality Assurance - Novato, CA | Biospace
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EU QP, CMC Quality Assurance

Ultragenyx Pharmaceutical Inc.

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Location:
Novato, CA
Posted Date:
11/22/2016
Position Type:
Full time
Job Code:
2016-1489
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
CMC, QA, Quality Assurance,

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!

Our headquarter is located in Novato, CA, 25 miles north of San Francisco.

Position Summary

Reporting to the Head of CMC Quality Assurance, the EU QP will support the Ultragenyx CMC Quality organization and execute the responsibilities of the EU Qualified Person for batch certification.  (S)he will work closely with colleagues in Quality, Technical Operations and Commercial to help deliver high quality,safe and efficacious products to patients in the EU.  The EU QP supports the development and manufacture of small molecule and biologic products from clinical through decommissioning, and develops and supports the Ultragenyx Corporate and Quality goals.

Responsibilities
•   Develop and lead a scalable, proactive Quality organization anticipating future needs in Europe.
•   Setting goals to support Quality and Corporate needs.
•   Represent Ultragenyx CMC Quality during inspections and / or during discussions with HA's and
with senior level leaders at Vendors when required.
•   Responsible for all duties of the Quality Person in the EU.
•   Responsible for product disposition decisions in the EU in consultation with the Head,CMC QA.
•   Support the development of a proactive, quality culture across the enterprise as required to fulfill duties.
•   Support the implementation of the Ultragenyx Quality System in Europe.
•   Collaborate with QA, Technical Operations and Vendors in resolving risks with permanent solutions.
•   Collaborate with business partners and Vendors to ensure successful planning, execution anddelivery of projects.
•   Help ensure activities and deliverables are in compliance with Swiss Medic, FDA, EMA and other global regulations and guidlines, ICH guidelines, Ultragenyx’ policies, SOP’s and industry best practices.
•   Other duties as assigned.

Requirements


•   Must be certified as a Qualified Person within the EU for both small molecule and Biologic
products.
•   A degree in a scientific discipline (Pharmacy, Biology, Chemistry, Biochemistry) required
depending on EU certification requirements.
•   Minimum of 10 years of experience in a CBER / CDER regulated industry.
•   Demonstrated ability to influence and maintain a quality culture.
•   Flexibility and the ability to manage change while accomplishing goals.
•   Knowledge of global cGMP’s, with a high focus on knowledge of EU laws and ordinances.
•   Strong interpersonal skills and the ability to work well as part of a team.
•   Exceptional verbal and written communication skills.
•   Demonstrated ability for analytical and systematic thinking.
•   Up to 30% travel required.