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The Director, CMC QA will report to the Senior Director of CMC QA and be responsible for maintaining strategic responsibility over QA Manufacturing Operations, developing and implementing Ultragenyx CMC 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.
In this role, in collaboration with key stakeholders in Technical Operations, DIR CMC QA provides quality 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:- 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.
- Review and approve changes related to facility, computerized systems, laboratory, or products.
- Perform final review of test data/reports to ensure conformance to the established specifications and standard operating procedures.
- Drive execution of risk assessments related to manufacturing processes for small molecule, biological products, and novel therapeutics (i.e., mRNA).
- Manage the lifecycle of products within the portfolio according to quality standards.
- Proactively engage with Tech Ops in addressing qualification requests.
- Proactively engage with Tech Development in addressing process development requests.
- 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.
- Other duties as assigned.
- Bachelor’s degree preferably in an Engineering, Biotechnology, Biological/Physical sciences, or equivalent.
- 10+ years of experience in a GMP biopharmaceutical manufacturing environment in technical operations and/or quality.
- Strong working knowledge and interpretation of FDA, EMA, local regulations and guidelines, Good Distribution Practices, ICH guidelines and industry best practice.
- Experience using and facilitating use of risk management tools (FMEA, PHA, etc.)
- Experience with performing technical assessment of changes for potential impact to qualification/validation of processes, equipment, utilities, facilities, and systems.
- Capability of collaboratively engaging with Contract Organizations.
- Experienced in all phases of biologic and small molecule drug development.
- Demonstrated high personal and professional ethical standards.
- Possesses excellent judgment with the ability to think and act quickly. Must be able to identify creative solutions to complex technical problems.
- Ability to interpret and relate Quality standards for implementation and review.
- Ability to communicate clearly and professionally both in writing and verbally.
- Strong organizational and project management skills with a track record of meeting goals/objectives.
- Strong experience with regulatory authority inspections, including both FDA and EMA.
- 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.
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].
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.
Skills Required
- Bachelor’s degree, preferably in engineering, biotechnology, biological or physical sciences, or equivalent
- 10+ years of experience in a GMP biopharmaceutical manufacturing environment in technical operations and/or quality
- Strong knowledge and interpretation of FDA, EMA, local regulations, Good Distribution Practices, ICH guidelines, and industry best practices
- Experience using and facilitating risk management tools such as FMEA and PHA
- Experience technically assessing changes affecting qualification or validation of processes, equipment, utilities, facilities, and systems
- Ability to collaboratively engage with contract organizations
- Experience across all phases of biologic and small molecule drug development
- High personal and professional ethical standards
- Excellent judgment and ability to act quickly and develop creative solutions to complex technical problems
- Ability to interpret and relate quality standards for implementation and review
- Clear and professional written and verbal communication skills
- Strong organizational and project management skills with a track record of meeting goals and objectives
- Strong experience with FDA and EMA regulatory authority inspections
Ultragenyx Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Ultragenyx and has not been reviewed or approved by Ultragenyx.
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Healthcare Strength — Benefits begin on the first day with multiple medical plan options alongside dental and vision coverage. Employer-funded HSA contributions and employer-paid mental health support via Spring Health add notable depth to healthcare support.
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Leave & Time Off Breadth — Paid time off is broadened by two fully paid company shutdown weeks in August and December in addition to holidays and baseline vacation. Paid sick time, paid volunteer time, and a substantial paid leave program further expand time-off support.
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Retirement Support — Retirement support includes a 401(k) program with a match on employee contributions and immediate vesting. An employee stock purchase plan discount also strengthens the overall financial rewards package.
Ultragenyx Insights
What We Do
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.
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