Director External Quality Assurance

Job 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:

ultra focused – Work together to fearlessly uncover new possibilities

The Director, CMC QA will report to the Senior Director of CMC QA and be responsible formaintaining strategicresponsibilityoverQAManufacturingOperations,developingandimplementingUltragenyxCMC Quality approach for assigned programs, and working with colleagues to improve processes utilized to ensure product quality. In addition, this position will use strong management skills to independently manage external partnerships.

Inthisrole,incollaboration withkeystakeholdersin TechnicalOperations,DIRCMCQAprovidesquality oversight and support to ensure clinical through commercial development lifecycle activities for drug substance and drug product meet cGMP regulatory requirements and guidelines.

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:

1. Review/approve investigation of operations in manufacturing/laboratory or other related operations and lead the strategic discussion for investigations with respect to operations related matters. Oversee resolution of quality events, monitor that recurrent events are properly escalated and resolved. Ensure root cause is determined, evaluate impact on product quality, disposition, and corrective actions.
2. Review and approve changes related to facility, computerized systems, laboratory, or products.
3. Perform final review of test data/reports to ensure conformance to the established specifications and standard operating procedures.
4. Drive execution of risk assessments related to manufacturing processes for small molecule, biological products, and novel therapeutics (i.e., mRNA).
5. Manage the lifecycle of products within the portfolio according to quality standards.
6. Proactively engage with Tech Ops in addressing qualification requests.
7. Proactively engage with Tech Development in addressing process development requests.
8. Develop and maintain procedures and practices in compliance with FDA, EMA, and local regulations and guidance, ICH guidelines, Ultragenyx policies/procedures, and industry best practices.
9. Other duties as assigned.

Requirements:

1. Bachelor’s degree preferably in an Engineering, Biotechnology, Biological/Physical sciences, or equivalent.
2. 10+ years of experience in a GMP biopharmaceutical manufacturing environment in technical operations and/or quality.
3. Strong working knowledge and interpretation of FDA, EMA, local regulations and guidelines, Good Distribution Practices, ICH guidelines and industry best practice.
4. Experience using and facilitating use of risk management tools (FMEA, PHA, etc.)
5. Experience with performing technical assessment of changes for potential impact to qualification/validation of processes, equipment, utilities, facilities, and systems.
6. Capability of collaboratively engaging with Contract Organizations.
7. Experienced in all phases of biologic and small molecule drug development.
8. Demonstrated high personal and professional ethical standards.
9. Possesses excellent judgment with the ability to think and act quickly. Must be able to identify creative solutions to complex technical problems.
10. Ability to interpret and relate Quality standards for implementation and review.
11. Ability to communicate clearly and professionally both in writing and verbally.
12. Strong organizational and project management skills with a track record of meeting goals/objectives.
13. Strong experience with regulatory authority inspections, including both FDA and EMA.
14. Travel will be required when appropriate (approximately 10%)

#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

$215,600—$266,300 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 [email protected] .

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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] .