Senior Manager, Quality Control Operations
4 weeks ago
Why Join Us?Be a hero for our rare disease patientsAt 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:ultrafocused - Work together to fearlessly uncover new possibilitiesReporting to the Director, Quality Control Operations, the Senior Manager, QC Operations and Stability will perform quality control functions supporting drug substance, drug product and cell banks. This individual with collaborate with cross functional stakeholders and externally with contract manufacturing facilities.Work Model: Core Lab & Ops: This role typically requires that the majority of the work be conducted on-site and thus will be subject to certain on-site safety protocols during the pandemic.Responsibilities:Evaluate product stability data to establish and extend product shelf-life.Assure ongoing readiness for regulatory inspection; participate in audits and inspections.Create and improve procedures.Support Regulatory submissions (e.g, INDs, BLAs), coordinate data requests, compilation and management of externally generated dataEnsures appropriate data integrity controls/ALCOA/data integrity issues for system requirements.Generation of Certificate of AnalysisServe as a technical lead for management of Quality Records: Global application of root cause, deviations, impact assessments, complex investigations in collaboration with other departments.Provide hands-on leadership for the QC Operations oversight of the group, data review, schedule and training.Provide oversight and support to contingent staff on siteRequirements:BS in Biology, Biochemistry, Chemistry or equivalent are of study/discipline7+ years of GMP experience in Pharmaceutical IndustryExperience in data management, LIMS experience preferredOrganized and skilled in managing multiple responsibilities, priorities, tasks and projects simultaneouslyStrong interpersonal skills that include negotiation, active listening, and relationship managementComfortable with interfacing effectively across all levels and organizationsIndependently motivated and detail-oriented with good critical thinking, problem-solving ability, and analytical skills #LI-CS1 #LI-OnsiteFull 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 countryUltragenyx 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.comSee our CCPA Employee and Applicant Privacy Notice.See our Privacy Policy.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.
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