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Director, CMC Quality Assurance
Location:
Bedford, MA
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 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: ultra impact - Make a difference for those who need it mostThe Director, CMC QA will report to the Executive Director of CMC QA and be responsible for maintaining strategic responsibility over QA Operations, developing and implementing Ultragenyx CMC Quality approach for assigned Gene Therapy programs, and working with colleagues to improve processes utilized to ensure product quality. In addition, this position will use strong management skills to independently manage external partnerships. In this role, in collaboration with key stakeholders in Technical Operations, Regulatory Affairs and extended Quality (ie. QC, Supplier Quality), you will provide Quality oversight and support to ensure clinical through commercial development lifecycle activities for drug substance and drug product meet cGMP regulatory requirements and guidelines at GTMF and/or contract manufacturing organizations (CMO). 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: Quality Assurance Lead for the cross-functional CMC Sub-Teams Influence the overall CMC development strategy throughout the product lifecycle based on current industry standards and health authority guidances Ensure GMP processes are implemented in the Quality Management System (QMS) for clinical and commercial product process lifecycle (e.g. control strategy, technology transfer, process validation lifecycle, continuous process verification) Provide oversight to ensure the creation of product characterization, product specifications, method validation, stability, and comparability assessments for technology transfers are in accordance with global regulatory requirements and internal procedures/policies Develop, approve, monitor and maintain critical quality standards to proactively minimize product quality risks, including application of controls supporting risk-based continued process verification and monitoring of lifecycle product quality Provide strategic guidance and quality support for significant changes and issue management (Deviations/CAPA) Author/review CMC sections of relevant regulatory dossiers and strategize responses to regulatory agency queries and Qualified Person (QP) queries throughout the product lifecycle Represent Ultragenyx to Health Authorities as a product quality expert Communicate and promote a culture of quality and operational excellence Other duties as assigned Requirements: BS degree preferably in an Engineering, Biotechnology, Biological/Physical sciences or equivalent. Minimum of 12 years experience in a GMP biopharmaceutical manufacturing environment in Technical Operations and/or Quality. Strong working knowledge and interpretation of FDA, EMA, local regulations and guidelines, Good Distribution Practices, ICH guidelines and industry best practice. Experience using and facilitating use or risk management tools (FMEA, PHA, etc.) Experience leading and participating in investigations into manufacturing and analytical deviations and determination of product impact, root cause, and corrective and preventive actions. Experience with performing technical assessment of changes for potential impact to qualification/validation of processes, equipment, utilities, facilities, and systems. Capability of collaboratively engaging with CMO's. Experienced in all phases of biologics, gene therapy, and/or cell therapy drug development. Demonstrated high personal and professional ethical standards. Possesses excellent judgement with the ability to think and act quickly. Must be able to identify creative solutions to complex technical problems. Abilit to interpret and relate Quality standards for implementation and review. Ability to communicate clearly and professionally both in writing and verbally. Strong organizational and project management skills with a track record fo meeting goals/objectives. Strong experience with regulatory authority inspections, including FDA and EMA. Travel may be required when appropriate (approximately 10%). Expert knowledge of cGMP compliance regulations and industry practices for US/Ex-US #LI-CK1 #LI-Onsite 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 XXXX@ultragenyx.com . See 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 : XXXX@ultragenyx.com . PDN-9bc96697-711f-4679-bae0-46ce439a4d82
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More About this Listing: Director, CMC Quality Assurance
Director, CMC Quality Assurance is a Quality Assurance QA Job at Ultragenyx located in Bedford MA. Find other listings like Director, CMC Quality Assurance by searching Oodle for Quality Assurance QA Jobs.
Director, CMC Quality Assurance is a Quality Assurance QA Job at Ultragenyx located in Bedford MA. Find other listings like Director, CMC Quality Assurance by searching Oodle for Quality Assurance QA Jobs.