Senior Manager, CMC QA in Bedford

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:

The Senior Manager, CMC QA will report to the Sr Director, CMC Quality Assurance. This role supports UGX QA Lot Disposition team performing tasks related to disposition and documentation activities for UGX and UGT product lots. This position is responsible for oversight and management of the Lot Release system, working proactively and cross-functionally to ensure lots are released according to schedule and Patient need.

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:

• Work proactively with TechOps planning function, to ensure lot release dispositions are clearly and appropriately scheduled.
• Work proactively to schedule and facilitate Production Planning meetings to ensure complete planning for production and subsequent lot release.
• Ensure review CMO executed manufacturing batch records per QA SOPs, according to schedule and internal KPI requirements.
• Ensure Certificate of Analysis documents are evaluated and found to be accurate by QC group.
• Understand QA systems such as raw material disposition, deviations, and change control to ensure batch records are compliant with these systems.
• Ensure batch record history files are compiled and KPIs are updated and current.
• Apply disposition to lots of material manufactured for Clinical, Early Access, and Commercial use. This includes, but not limited to, Starting Materials, DS, DP, FG.
• Ensures archival of completed and reviewed manufacturing batch records.
• Drive change control accuracy, completeness, and transparency through the Change Review Forum.
• Perform the Change Control QA Role, where needed.
• Identify opportunities for improvement in Lot Release and Change Control, and use continuous improvement tools to drive implementation of improvements.
• Perform QMS data collection and trending for all APQR activities.
• Plan and coordinate cross-functional meetings with QP/QO/RP.
• Other duties as assigned.

Requirements:

• Bachelor’s degree in a science or related technical field with no less than 7 years relevant industry experience.
• Working knowledge of desktop computers.
• Demonstrated ability for detail-oriented work.
• This individual must exhibit strong compliance, organization, and communication skills.
• In depth knowledge of pharmaceutical regulations including 21 CFR Part 11, GMPs, GCPs, GAMP 5, and Annex 11.
• Extensive experience in managing multiple validation projects, developing plans, managing to project schedules and directing vendor/contract resources in creating CSV deliverables.
• Diverse experience validating GxP-regulated applications for quality management, regulatory submissions, controlled document management solutions and clinical development.
• Must possess excellent communication, conflict resolutions, influence and problem-solving skills.
• Deep understanding of the validation methodologies applied to on-prem applications and hosted environment.
• Strong attention to detail, quality oriented.
• Must be self-motivated and comfortable in a fast-paced, demanding and dynamic work environment.

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: $174,900 - $216,100 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.