Associate Director, Deviation Management at Ultragenyx in Bedford, 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:

This role will provide Quality Assurance oversight for the execution of the Deviation and CAPA Management process for internal GMP operations at both the Gene Therapy Manufacturing Facility (GTMF) located in Bedford, MA and the Quality Control Laboratories located in Woburn, MA. This role will ensure Deviations and CAPA are executed in a robust manner to prevent recurrence of nonconformances by driving to root cause and establishing effective CAPA. This role will assess and improve maturity of the Deviation and CAPA process using various techniques such as trend analysis, review of establish metrics, and auditing of records. The role will also support Deviation and CAPA training. This position will work closely with Manufacturing, (Local) Supply Chain / Warehouse, Facilities, Engineering, Quality Control, and MSAT.

ultraimpact – Make a difference for those who need it most

Work Model:

Core Lab & Ops: This role typically requires that the majority of the work be conducted on-site

Responsibilities:

Provide oversight of open Deviation and CAPA records to ensure timely and effective completion
Evaluate maturity of the Deviation and CAPA process execution; identify and drive improvement opportunities
Provide training and coaching on the Deviation and CAPA process for new and existing owners or approvers. Constantly improve existing training to facilitate improved execution
Develop and maintain Quality System metrics to measure the health and effectiveness of Deviation and CAPA process execution at UGT
Perform trend analysis on deviations to proactively identify repeat or recurring trends. Escalate negative trends and lead corrective actions
Be an expert with the Deviation and CAPA process. Own and/or approve critical deviations when necessary
Work closely with the Global Quality Systems team to drive continuous improvement to the Deviation and CAPA process and platform (ie. Veeva)

Requirements:

Minimum of a Bachelor’s Degree in a science, engineering, or related technical discipline
8+ years of experience in biopharmaceutical or biotechnology GMP operations with at least 4+ years of experience with commercial products
Demonstrated experience with Deviation and CAPA management by owning, writing, or approving complex deviation records
Strong organizational and project management skills with a track record of meeting goals/objectives
Broad and direct experience with regulatory authority inspections, including both FDA and EMA inspections
Proficiency with data analysis tools to identify trends
Excellent communications skills, both written and verbal
Excellent teamwork, interpersonal skills, influencing skills and negotiation skills
Travel may be required up to 10%. Most travel will be between Ultragenyx locations located in Boston or San Francisco areas

#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$180,300—$222,700 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.

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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: talentacquisition@ultragenyx.com.