Associate Director / Director, CMC QA

Company: Ultragenyx Pharmaceuticals
Location: Novato
Posted on: January 11, 2021

Job Description:

Why Join Us?Be a hero for our rare disease patientsUltragenyx is a commercial-stage biopharmaceutical company committed to developing novel therapies for the treatment of rare and ultra-rare genetic diseases. The company has rapidly built a diverse portfolio of small molecule, monoclonal antibody, mRNA and gene therapy candidates with the potential to address debilitating genetic diseases for which the unmet medical need is high, the biology for treatment is clear, and for which there are typically no approved therapies treating the underlying disease. Developing new treatments for rare genetic diseases is challenging work. It takes courage, talent, and dedication to look past the easy answers and uncover new solutions that can make a meaningful impact. At Ultragenyx we push each other to perform at our very best, because we never lose sight of our mission --- to make a difference in our patients--- lives.Come join our team during this exciting time of growth and opportunities During the COVID-19 Outbreak we are committed to our hiring process. The health and safety of our employees and prospective employees take priority which means at this time our process will include WebEx video discussions, interviews & onboarding.Position Summaryultrafocused --- Work together to fearlessly uncover new possibilitiesThe Associate Director/Director, CMC QA will maintain strategic responsibility over QA Manufacturing Operations and will implement and communicate Ultragenyx---s CMC quality approach for the company. This role will direct and oversee operations in accordance with GxP regulations and Ultragenyx standards. This is an individual contributor role. Responsibilities including, but not limited to:Collaborate with Management and lead strategic interactions with internal and external customers to negotiate actions impacting implementation and supply of quality product to patients from design/development stages to and including commercial operations.Design, develop, and lead efforts for QA oversight of the manufacture and disposition of pre-clinical, clinical and commercial product materials, DS, DP and Finished Goods at CMOs in partnership with Technical Operations, Product Development, Supply Chain and other functions.Manage and develop processes and talent that provides overall Quality oversight to CMOs that manufacture small molecules, biologics and novel therapeutics (i.e., mRNA).Deploy resources to and/or negotiate and manage quality agreements.Help ensure quality of products produced / maintained at CMOs through review and approval of cleaning, sterilization and process validation, process simulations, shipping qualifications, equipment/facility/utility qualifications, deviation investigations, lot release, significant changes, and CAPA development related to manufacturing of Ultragenyx products, and work with Technical Operations and our CMOs to resolve recurring problems with permanent solutions. Execution of Quality Systems in an Owner/SME or QA role, for Deviations, Change Controls, Risk Management, Quality Review Board, and Annual Product Quality Review. Lead and actively participate in Continuous Improvement initiatives and projects, ensuring a focus on increasing both efficiency and quality output from all processes used by the CMC QA and cross-functional partners.Ensure development and monitoring of quality metrics at the CMOs that predict the performance and health of the quality systems and processes.Represent Ultragenyx to health authorities as a company expert.Knowledge of clinical and commercial supply chain including orphan drug distribution channels, early access programs and partner management Assume leadership roles in CMC teams as assigned (either as an active participant or as a CMC lead).Ensure completeness of technical evaluation and quality due diligence activities in support of CMO site selection process Provide stewardship of the quality risk profile and team risk; log and approve risk controls strategies at CMOs both in the selection and manage phases. Author/Reviewer CMC BLA, INDs, MAA and other relevant regulatory dossier sections based on area(s) of knowledge and expertise. Strategize responses to regulatory questions during review period and product lifecycle. Participate in Governance support teams at CMO sites. Act as co-auditor during cGMP audits at CMOs, when requested by Inspection Management.Collaborate with CMC Leads and Portfolio Management partners to ensure successful planning, execution and delivery of projects.Design, develop, and review CMC QA standards and procedures (i.e., policy documents and SOPs). Review and support deployment of Quality Standards generated by the Quality System Department.Ensure activities and deliverables are in compliance with FDA, EMA and local regulations and guidance, ICH guidelines, Ultragenyx policies, SOPs and industry best practices.Support and endorse completion of regulatory requirements and expectations for manufacturing network.Represent CMC QA at various forums May participate in external collaborations to influence policy, practices and current guidance for the manufacture of biologics, small molecules and novel therapeutics.May act as deputy of Quality in governance bodies making decisions on product and material specifications.Other duties as assigned.Requirements: Level commiserate with experience.Bachelor---s degree or equivalent work experience in QA Manufacturing Operations or related discipline. 10 years of experience in a GMP biopharmaceutical manufacturing environment in technical operations and/or quality. Demonstrated ability to lead, participate and successfully complete continuous improvement projects, applying concepts such as project management, lean, 6-sigmaProficient in root cause analysis tools.Experience using and facilitating use of risk management tools (FMEA, PHA, etc.)Ability to develop CMC QA vision and mission. Constantly inspires team to realize department vision and mission.Demonstrate quality mindset and influences across the entire organization.Understanding of unique quality and manufacturing expectations from other regulatory authorities such as EMA, ANVISA, MHRA, etc.Expert knowledge of cGMPs. Knowledge and experience negotiating quality agreements. Flexibility and the ability to manage change.Strong interpersonal skills and the ability to work well as part of a team.Demonstrated ability for analytical and systematic thinking.20% TravelLI-CV1Ultragenyx 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 status. Reasonable accommodation will be provided for qualified individuals with disabilities and for qualified disabled veterans in job application procedures, as required by applicable law. If 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 talentacquisitionultragenyx.com. For electronic email and mail inquiries, please include a description of your requested accommodation, your name and contact information.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: talentacquisitionultragenyx.com.Novato, CA or Brisbane, CA /Ultragenyx --- Quality /Full-time

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