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:

We are looking for an experienced Quality Assurance (QA) Manager to support the Ultragenyx EMEA Quality team and the EU Qualified Persons (QP) with Quality operations, manufacturing batch documentation review and distribution activities of our biological products, ensuring compliance and operational excellence across the activities. You must be living in the Netherlands as our office is located at Schiphol (Amsterdam) with the possibility to work hybrid.

If you are curious, like to explore new challenges, enjoy working in an international environment, and value quality and compliance, you are the right candidate to join our team.

ultrainnovative – Tackle rare and dynamic challenges

Work Model:

Flex: This role will typically require onsite work 2-3 days each week, or more depending on business needs. In many locations, the business will set certain days each week that Flex employees are required to be onsite.

Responsibilities:

Support the Ultragenyx EMEA Quality team with ensuring compliance with EU and national quality provisions for the pharmaceutical activities performed under Good Manufacturing and Good Distribution Practices.
Supporting the EU QPs with manufacturing batch record review and preparation for batch certification process.
Handling of deviations and CAPAs, change controls and complaints associated to the manufacturing and distribution of medicinal products.
Managing and maintaining the Quality Systems including key performance indicators related to our pharmaceutical licenses for the Netherlands and other offices in the EMEA region.
Act as regional training coordinator, LMS and Veeva SME key contact point.
Manage the self-inspection and supplier qualification program regionally.
Support in setting up Quality Technical Agreements with contract organizations and distribution partners.

Requirements:

At least a Bachelor’s degree or equivalent in a bio-scientific discipline (Pharmacy, Biology, Chemistry, Biochemistry) is required, with at least 5 years of work experience in the pharmaceutical industry
At least 3 years of experience working in batch documentation review of Biological Drug substances (Upstream and Downstream operation) as well as filling and finishing of sterile Drug Products..
Strong experience working with LMS and Veeva Vault as key user or SME.
Good knowledge of the GMP and GDP guidelines and regulatory frameworks
Fluent orally and written in English, Dutch is a preference.
Team player who would like to become part of our international team.
Quality mindset and ability for analytical and systematic thinking.
Knowledge of IT programs (e. g. MS Office, QMS Electronic Data Management Systems).
Willingness to work in a hybrid environment in an international and interdisciplinary team.
Good collaboration and communications skills.
Must hold a valid work permit for the Netherlands

#LI-CK1 #LI-Hybrid

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

· Long term incentive and Employee stock purchase plans or equivalent offerings

· Employee wellbeing benefits

· Fitness reimbursement

· Tuition sponsoring

· Professional development plans

* Benefits vary by region and country

Ultragenyx Pharmaceutical is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status, and any other status or classification protected by applicable federal, state, and/or local laws. Reasonable accommodation will be provided for all protected statuses or classifications protected by applicable law, including individuals with disabilities, disabled veterans, for pregnancy, childbirth, and related medical conditions, and based on sincerely held religious beliefs. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or in any part of the recruitment process, you may contact Talent Acquisition by emailing us at [email protected].

See our CCPA Employee and Applicant Privacy Notice.

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It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

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: [email protected].

Quality Assurance Manager EMEA- Fixed Term Contract

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