Job details
Job type temporary
Full 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 doTo achieve this goal, our vision is to lead the future of rare disease medicineFor 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 treatmentsWe 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 themOur commitment and care for patients extends to our people, so culture is an essential cornerstone for ultragenyxWe 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 workUltimately, we want to be an organization where we would be proud for our family, friends and children to workIf 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 teamDuring the covid-19 outbreak, we are committed to our hiring processThe health and safety of our employees and prospective employees take priority which means at this time our approach will include video discussions, interviews, and onboarding.
Position summary ultra dedicated – your biggest challenges yield rare possibilities we are seeking a highly motivated qa analytical senior manager/associate director with experience in quality control in support of early/late phase clinical and commercial stage development and productionThe candidate will report to the cmc qa technical & qc support director and will support analytical qa activities, while working closely with cmc qa, analytical development and cmc quality control, and other cross-functional teams in pre-clinical, clinical and commercial biologics and small molecule ds and dp programs.
Starting on january 3rd, 2022, full vaccination against covid-19 is a condition of employment at ultragenyxThis requirement applies to almost all roles at ultragenyx based in the u.s., with very limited exceptionsIf you are unable to receive a covid-19 vaccine due to a disability, serious medical condition, or because it would violate your sincerely held religious belief, you will have an opportunity to request a reasonable accommodation.
Responsibilities:
Provide qa support of activities related to method development, method validation and transfer studies, method performance monitoring, specification settings, important reagent and assay standards suitability for continued use, reference standards, trending and stability programsThis includes qa oversight of method lifecycle and documentation (e.gMethod development reports, method validation studies, sops, important reagent qualification, implementation/maintenance of standards and controls, reference standard qualification, stability protocols/reports, specifications, certificate of testing/analysis) requirements.
Provide change management and deviation/oos/ooe/oot investigation event support.
Provide qa review of source documentation supporting cmc bla, inds, regulatory information requests, and other relevant regulatory dossier sections based on area(s) of expertise.
Ensure activities and deliverables comply with fda, ema and local regulations and guidance, ich guidelines, ultragenyx policies, sops and industry best practices.
Other responsibilities as assigned, such as participate in internal discussions to support development of quality agreements with contract testing laboratories, root cause analysis and risk assessments.
You may be remote or located in brisbane, ca, with occasional on-site meetings in novato.
Technical requirements & skills:
A bachelor`s degree or equivalent work experience in quality control or related discipline.
Minimum of 3 years of experience in qa.
5+ years of experience in a cber/cder regulated industry.
Understanding of quality, and stability expectations from other regulatory authorities such as ema, anvisa, mhra,
Expert knowledge of cgmps.
Experience with analytical development and qc (e.gCompendial methods, hplc, ce, gc, sds-page, nmr) support product lifecycle development from early-phase clinical through commercial.
Experience with application of statistical tools for data analysis/trending.
Experience managing contract testing labs and cmos.
Experience establishing quality agreements with contract testing laboratories a plus.
Strong interpersonal skills and the ability to work well as part of a team.
Ability for systematic thinking.
Exceptional verbal and written communication skills.
Experience in risk assessment and root cause analysis tools.
Experience with the following software: microsoft word, excel and powerpoint is required.
Experience with veeva electronic quality management system (eqms) or similar.
Ultragenyx pharmaceutical is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran statusReasonable accommodation will be provided for qualified individuals with disabilities and for qualified disabled veterans in job application procedures, as required by applicable lawIf you have any difficulty using our online application system and need an accommodation due to a disability, you may contact talent acquisition by calling: (415) 483-8800 or by emailing us at talentacquisition@ultragenyx.comFor electronic email and mail inquiries, please include a description of your requested accommodation, your name and contact information.
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Note to external recruiters: all candidate activity and open positions are managed strictly through our human resources departmentOur human resources department kindly requests that recruiters not contact employees/hiring managers directly in an attempt to solicit business and present candidatesPlease note that failure to comply with this request will be a factor in determining a professional relationship with our organizationSubmission of unsolicited resumes prior to an agreement set in place between the human resources department and the recruiting agency will not create any implied obligationInquiries on developing a recruiting relationship with us, may be directed to: talentacquisition@ultragenyx.com.
