Manager, Quality Systems

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:

ultra dedicated – Your biggest challenges yield rare possibilities

The Manager Quality Systems will provide technical quality expertise in the development, implementation, and continuous improvement of cGMP compliant quality systems, to ensure compliance with internal policies and procedures and applicable regulations at Ultragenyx Gene Therapy. The Manager will support and provide oversight of quality system related activities for internal and external operations in areas such as Change Controls, Quality Management Review and Monthly Metrics, Supplier Notification of Changes, Deviation and CAPA, SNOC and SCAR.

The Manager reports to the Director, Quality System Operations at Ultragenyx Gene Therapy.

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:

• Actively partners with the Global and Site Teams to support adherence to the Quality Management System principles, company projects and other activities.

• Support compliant quality systems, including but not limited to document control, change control, investigations, deviations, CAPA, Audit readiness and product/customer complaints. Write and/or review associated SOPs, forms, and templates.

• Leads the review of site and global quality metrics by creating metric reports, participating in huddles/meetings, and following up with record owners to ensure a state of control by driving actions to resolve current or potential issues as appropriate.

• Manages the Change Control review board ensuring changes are meeting expectations and are presenting in a timely manner.

• Leads the issuance of SNOCs, SCARs and external deviations. Creating records, assigning numbers and tracking documents to closure where appropriate.

• Provide technical expertise and guidance to the user community by supporting, troubleshooting or managing deviations, investigations, changes, risk assessments and CAPAs.

• Leads small implementation projects for the QMS, ensuring configuration is completed per user requirements, and testing is completed correctly.

• Ensure that manufactured gene therapy products are of high quality, safe for human use, and are following cGMP and international regulations.

• Work effectively and collaboratively with local and global cross-functional teams, such as pharmaceutical development, manufacturing, quality control, regulatory affairs, and program management.

• Manage competing priorities to meet departmental and organizational targets and timelines

• Collaborate with QMS BSO and other Veeva BSOs on maintenance and enhancements and configuration testing for ITCRs

• Support CoP and QSMR activities where applicable

• Participate in internal audits and inspections as needed.
• Promote a culture of quality and operational excellence.
• Other activities as per request.

Requirements:

• A bachelor's degree in a scientific discipline required.

• 4 years of experience in pharmaceutical / medical device industry.

• Demonstrated experience with creating and implementing effective cGMP quality systems, inclusive of writing SOPs.

• Demonstrated experience managing Change Control, Deviation and their associated CAPAs, Investigations, Supplier Notification of Changes and Supplier Corrective Actions Requests a plus.

• Understanding and application of industry standards and cGMP/international regulations and guidelines.

• Experience in developing interactive quality system and cGMP training programs and tracking and trending quality metrics associated with key performance indicators

• The desire and ability to work in a fast-paced, start-up environment

• Strong collaboration, teamwork, organizational skills at attention to detail

• Excellent written and verbal communication skills including presentations to cross-functional meetings, senior management and to key external stakeholders

• GMP knowledge and experience required, GLP and GCP considered a plus.

#LI-CT1, #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.

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: [email protected].