Director/Executive Director, CMC QA & External Manufacturing

Company: Amazon Workforce Staffing
Location: Cambridge
Posted on: September 17, 2020

Job Description:

Senior Director/Executive Director, CMC QA & External Manufacturing Company: Lever

Location: Cambridge

Posted on: September 12, 2020

Job Description:

Senior Director/Executive Director, CMC QA & ExternalManufacturing Ultragenyx is a commercial-stage biopharmaceuticalcompany committed to developing novel therapies for the treatmentof rare and ultra-rare genetic diseases. The company has rapidlybuilt a diverse portfolio of small molecule, monoclonal antibody,mRNA and gene therapy candidates with the potential to addressdebilitating genetic diseases for which the unmet medical need ishigh, the biology for treatment is clear, and for which there aretypically no approved therapies treating the underlyingdisease.

With the company’s recent acquisition of Dimension Therapeutics,the Ultragenyx Gene Therapy division was established. TheUltragenyx Gene Therapy division is headquartered in Cambridge, MA.We are looking for exceptional individuals who share our passionfor developing novel therapies to treat rare diseases and advancingthe field of gene therapy.

Developing new treatments for rare genetic diseases ischallenging work. It takes courage, talent, and dedication to lookpast the easy answers and uncover new solutions that can make ameaningful impact. At Ultragenyx we push each other to perform atour very best, because we never lose sight of our mission – to makea difference in our patients’ lives.

Come join our team during this exciting time of growth andopportunities! During the COVID-19 Outbreak we are committed to ourhiring process. The health and safety of our employees andprospective employees take priority which means at this time ourprocess will include WebEx video discussions, interviews &onboarding.

Position Summary

-Maintain strategic and operational responsibility over QAManufacturing Operations.

-Implement and communicate Ultragenyx’s CMC qualityapproach.

-Direct, oversee and enable staff and operations in accordancewith GxP regulations and -Ultragenyx standards.

-Manage performance and development of direct reports to ensureachievement of organizational and department goals and an engagingand productive environment

Responsibilities Lead interactions with senior management andinternal and external customers to negotiate actions impactingimplementation and supply of quality product to patients from earlydevelopment stages to on-going commercial operations.

Design, develop and lead efforts for QA oversight of themanufacture of pre-clinical and commercial DS and DP at CMOs inpartnership with Technical Operations, QC, Product Development,Supply Chain and other functions.

Manage and develop talent that provides overall Qualityoversight to CMOs manufacturing gene therapies, plasmids, andclinical trial materials.

Deploy resources to and/or negotiate and manage qualityagreements. Ensure effective execution of our Quality TechnicalAgreements.

Help ensure quality of products produced / maintained at CMOsthrough review and approval of key activies to include; cleaning,sterilization and process validation, process simulations, shippingqualifications, equipment/facility/utility qualifications,deviation investigations, significant changes, and CAPA developmentrelated to the manufacturing of Ultragenyx products. Partner withTechnical Operations and our CMOs to resolve recurring problemswith permanent solutions.

Ensure development of quality metrics at the CMOs that predictthe performance and health of the quality systems andprocesses.

Represent Ultragenyx to health authorities as a companyexpert.

Support and coach team members that represent QA on CMCteams

Ensure completeness of technical evaluation and quality duediligence activities in support of the CMO site selectionprocess.

Provide stewardship of the quality risk profile and approve riskcontrol s strategies at CMOs both in the selection and managephases.

Author/Reviewer CMC BLA, INDs and other relevant regulatorydossier sections based on area(s) of knowledge and expertise.Strategize responses to regulatory questions during the reviewperiod and product lifecycle.

Participate in Joint Steering Committee (JSC) at CMO sites.

Collaborate with CMC Leads and Portfolio Management partners toensure successful planning, execution and delivery of projects.

Design, develop, and review CMC QA standards and. Own, Reviewand support deployment of Quality Standards.

Ensure activities and deliverables are in compliance with FDA,EMA and local regulations and guidance, ICH guidelines, Ultragenyxpolicies, SOPs and industry best practices.

Represent CMC QA at various forums as assigned by the UGT VP ofQuality Assurance.

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 makingdecisions on product and material specifications.

Other duties as assigned.

Requirements A Bachelor’s degree or equivalent work experiencein QA Manufacturing Operations or related discipline, master degreeor above preferable.

+15 years’ experience in pharmaceutical / device industry.

Minimum of 10 years of experience in a Quality Organization in aCBER/CDER regulated industry.

+10 years’ experience leading and developing teams.

Experience in product lifecycle management as CMC teammember.

Ability to develop CMC QA vision and mission. Constantlyinspires team to realize department vision and mission.

Demonstrate quality mindset and influences across the entireorganization.

Ability to manage budget and resourcing and to lead adepartment.

Understanding of unique quality and manufacturing expectationsfrom 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 partof a team.

Exceptional verbal and written communication skills.

Demonstrated ability for analytical and systematic thinking.

Proficient in risk assessment and root cause analysis tools.

Ingenuity to develop quality processes that fit virtual DS andDP product manufacturing operations for biologics, small moleculesand novel therapeutics.

Support and recommend approaches to CMC rapid development forrare and ultra-rare disease products.

Experience with the following software: Microsoft Word, Excel,PowerPoint, and Project is required. Experience with Veevaelectronic quality management system (eQMS) is a plus.

Travel up to 30% of total work hours.

#LI-CZ1 Ultragenyx Pharmaceutical is an equal opportunityemployer & prohibits unlawful discrimination based on race, color,religion, gender, sexual orientation, gender identity/expression,national origin/ancestry, age, disability, marital and veteranstatus. Reasonable accommodation will be provided for qualifiedindividuals with disabilities and for qualified disabled veteransin job application procedures, as required by applicable law. Ifyou have any difficulty using our online application system andneed an accommodation due to a disability, you maycontact Talent Acquisition by calling: (415)483-8800 or by emailing us at talentacquisition@ultragenyx.com . For electronic email and mailinquiries, please include a description of your requestedaccommodation, your name and contact information.

Note to External Recruiters : All candidate activity and openpositions are managed strictly through our Human ResourcesDepartment. Our Human Resources Department kindly requests thatrecruiters not contact employees/hiring managers directly in anattempt to solicit business and present candidates. Please notethat failure to comply with this request will be a factor indetermining a professional relationship with our organization.Submission of unsolicited resumes prior to an agreement set inplace between the Human Resources Department and the recruitingagency will not create any implied obligation. Inquiries ondeveloping a recruiting relationship with us, may be directed to: talentacquisition@ultragenyx.com .

Keywords: Lever, Cambridge , Senior Director/Executive Director, CMC QA & External Manufacturing, Other , Cambridge, Massachusetts

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Keywords: Amazon Workforce Staffing, Cambridge , Director/Executive Director, CMC QA & External Manufacturing, Other , Cambridge, Massachusetts