Director, Quality Assurance Operations at Ultragenyx in Woburn, MA

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:

ultradedicated – Your biggest challenges yield rare possibilities

The Director, QA Operations supports all quality activities including disposition of product manufactured at Contract Organizations for early and late stage clinical programs as well as commercial product. The Director, Quality Operations provides technical quality expertise in the review and maintenance of cGMP batch production files and label/packaging records. This role is responsible to lead quality decision-making in the execution of quality systems: change management, deviation/CAPA management, and product quality complaint handling management. The successful candidate will ensure product quality operations is compliant with applicable GxP regulations, ICH guidelines, Ultragenyx standards, and industry best practices.

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:

Leads on time disposition of Ultragenyx’s multi-product Biologics and Small Molecule portfolio in compliance with cGMPs across various manufacturing stages including cell banks, drug substance, drug product, and finished product
Provides QA review and approval of production batch records, change controls, deviations, CAPA and product quality complaints
Supports internal and external Qualified Persons (QP) activities related to QP batch confirmation and batch certification
Develops and prepares quality metrics for Quality Systems Management Review
Participates in continuous improvement projects to enhance the overall health of the quality systems and drive efficiencies in operational processes
Ensures significant quality risks are escalated and mitigated in a timely manner
Supports Global Annual Product Review/Product Quality Review in partnership with Quality Leads and collaboration with Tech Ops and Reg CMC
Represents Ultragenyx to Health Authorities during inspections
Communicates and promotes a culture of quality and operational excellence
Other duties as assigned

Requirements:

BS degree in a scientific/technical discipline is required, advanced degree preferred
Minimum of 10 years’ experience in a GxP biotechnology or pharmaceutical environment is required, Biologics and Small Molecule experience preferred
Minimum of 5 years’ experience in Quality in a CBER/CDER regulated industry
Minimum of 5 years’ experience leading and developing high performing teams
Proficiency in Oracle is desired
Strong understanding of cGMP compliance regulations and industry practices
Demonstrated quality mindset and ability to influence across a matrix organization
Ability to manage multiple priorities and aggressive timelines
Experience with Veeva electronic quality management system (eQMS) is a plus
Travel: approximately 5% #LI-CS1 #LI-Hybrid

The typical annual salary range for this full-time position is listed below. This range reflects the characteristics of the job, such as required skills and qualifications and is based on the office location noted in this job posting. The range may also be adjusted based on applicant's geographic location.

This position is eligible for annual bonus and equity incentives. Actual individual pay is determined by demonstrated experience and internal equity alignment.

Pay Range$213,400—$263,700 USD 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. 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.