Senior Specialist, QA Document Control

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: ultrafocused – Work together to fearlessly uncover new possibilities Reporting to the Associate Director, Doc Control, the Senior Document Control Specialist will perform a wide variety of activities pertaining to GMP Document Control and Records Management for our Quality Control Labs and as needed, our Gene Therapy Manufacturing Plant. This is a critical position and will be responsible for the processing and maintaining of GxP documents and training records throughout their lifecycle. This position is considered a Core Lab and Operations role and will require on-site presence every day at our Woburn, MA Quality Control lab Work Model: Core Lab & Ops: This role typically requires that the majority of the work be conducted on-site. Responsibilities: Routine oversight of the document control and training systems effectiveness. Manage the documentation storage room. Organize and manage a high volume of documentation for archival in both electronic and paper-based processes Reviewing documents for completeness, grammar, formatting, and good documentation practices to ensure documents meet procedural and business required (e.g., appropriate metadata, references, etc.). Perform administrative tasks for electronic document/training management systems, including issuance of new accounts, revising user access levels, and updates to system set-up Issuing/Reconciling Controlled Documents Issuing/Reconciling Periodic Review Tasks Reporting and monitoring Document Control Metrics to ensure compliance within Ultragenyx processes and procedures Write, review, and approve SOPs in an area of expertise. Retrieval of documentation upon internal customer request Provide Document Control support in preparation of, during and after internal or external Audits/Inspections Requirements: BS in related field with 6+ yrs. experience, science degree preferred Direct experience in document control, quality systems and training Experience with e-DMS systems in pharmaceuticals and/or medical device (experience in Veeva Vaults preferred) Demonstrated working knowledge of GxP quality systems requirements Working knowledge of ICH/GxP regulations and expectations Strong attention to detail is required. A team player with excellent cross-functional partnership skills and proven track record to work across the organization. Collaborates and communicates transparently, listening and understanding effectively, and inviting response and discussion with key stakeholders. Strong knowledge of MS Word and MS Excel is required. Understanding of creating fillable forms in Adobe is a plus. Must be independent, self-motivated, organized, able to multi-task and skilled in communication. Ability to plan, organize and execute multiple documents and tasks simultaneously. #LI-CT1 #LI-Onsite 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 $103,400—$127,700 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. See our CCPA Employee and Applicant Privacy Notice. See our Privacy Policy. 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.