Quality Assurance Manager EMEA- Fixed Term Contract at Ultragenyx Pharmaceutical

Amsterdam, North Holland, Netherlands -

Full Time

Start Date

Immediate

Expiry Date

04 Feb, 26

Salary

0.0

Posted On

06 Nov, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Assurance, GMP, GDP, Analytical Thinking, Systematic Thinking, Team Player, Compliance, Quality Systems, Pharmaceutical Activities, Batch Review, Deviation Handling, Supplier Qualification, Technical Agreements, Change Management, IT Programs, Collaboration

Industry

Biotechnology Research

Description

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 review and distribution activities. You preferably live in the Netherlands as our office is located at Schiphol (Amsterdam) with the possibility to work both from the office and from home. If you are curious, like to explore new challenges, prefer working in an international environment, and quality and compliance are important to you, 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. Managing and maintenance of the Quality Systems related to the Manufacturing and Importation Authorisation (MIA) and Wholesale Distribution License (WDA) of our office in the Netherlands and supporting the offices in the EMEA region. Writing and revising quality procedures related to the pharmaceutical activities of Ultragenyx EMEA in collaboration with the Global Quality team (US Headquarters). Supporting the EU QPs with manufacturing batch record review and the EU batch certification process. Including handling of deviations, technical product defects and complaints in the wholesale with medicinal products including participating in investigations. Support with the handling of changes that may affect the manufacturing or distribution of medicinal products. Participate in the self-inspection and supplier qualification program, including monitoring the performance at appropriate regular intervals following a prearranged program and necessary corrective measures are put in place. Support in setting up Quality and 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 Good knowledge of the GMP and GDP requirements and applicable EU guidelines. 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, etc.) Willingness to work in a hybrid environment in an international and interdisciplinary team #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 talentacquisition@ultragenyx.com. See our CCPA Employee and Applicant Privacy Notice. See our Privacy Policy. 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: talentacquisition@ultragenyx.com.

Responsibilities

Support the Ultragenyx EMEA Quality team with compliance to EU and national quality provisions. Manage Quality Systems related to Manufacturing and Importation Authorization and support the EU Qualified Persons with batch record review and certification processes.