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.
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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
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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.
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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.
