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Head of Quality

Company: Amazon Shopper
Location: Kirkland
Posted on: September 12, 2020

Job Description:

Company: Fred Hutchinson Cancer Research Center

Location: Seattle

Posted on: August 14, 2020

Job Description:

Cures Start Here. At Fred Hutchinson Cancer Research Center,home to three Nobel laureates, interdisciplinary teams ofworld-renowned scientists seek new and innovative ways to prevent,diagnose and treat cancer, HIV/AIDS and other life-threateningdiseases. Fred Hutch's pioneering work in bone marrowtransplantation led to the development of immunotherapy, whichharnesses the power of the immune system to treat cancer. Anindependent, nonprofit research institute based in Seattle, FredHutch houses the nation's first and largest cancer preventionresearch program, as well as the clinical coordinating center ofthe Women's Health Initiative and the international headquarters ofthe HIV Vaccine Trials Network. Careers Start Here.The Fred HutchTherapeutic Products Program (TPP) encompasses two, distinct,clinical manufacturing facilities in support of Phase I/II clinicaltrials. Trials consist of both internal, faculty-driven protocolsas well as external partnerships with peer institutions andindustry partners.The Cell Processing Facility (CPF) performs cGMPmanufacturing activities for cell therapy clinical trials involvingthe selection, genetic modification, and ex-vivo expansion of stemcells, T-cells, and B-cells. The CPF works with both internal FredHutch investigators and external collaborators to manufacturecellular products in support of early phase clinical trials anddevelopment programs. Similarly, the Biologics Production Facility(BPF) performs cGMP manufacturing activities in support of PhaseI/II clinical trials involving monoclonal antibodies, fusionproteins, plasmids, Lentiviral vectors and similar, mammalian andbacterial-based cultures.Reporting to the Sr. AdministrativeDirector of TPP (with a dotted-line reporting to the Chief Ethicsand Compliance Officer), the responsibilities of the Head ofQuality are to provide leadership, direction, and coaching to thesite quality organizations. This individual will be responsible forleading the day to day Quality Operations for Quality Assurance,Document Control and Quality Control. Responsibilities includeimplementation and continuous improvement of policies, proceduresand standards necessary to ensure compliance with Phase I/II GMPs.Additional responsibilities include team building, careerdevelopment, assisting with financial reviews, establishment ofannual budgets and identification and rollout of yearly goals andobjectives and longer-term strategic plans for the departments.Theposition will involve managing multiple staff members across thequality organization including direct-line supervision ofManagers/Sr. Managers in QA and QC along with responsibility forDocument Control personnel.The successful applicant will interacton a daily basis with clinical trial sponsors, manufacturing,research scientists, project management, and senior members of FredHutch faculty and administration.Specific responsibilities willinclude:+ Provide senior leadership for the TPP Quality departments(QA and QC)+ Demonstrate outstanding technical acumen, operationalunderstanding and GMP compliance in the maintenance and continuedexpansion of both manufacturing facilities+ Lead the CPForganizational initiative to become FACT Accredited (Foundation forthe Accreditation of Cellular Therapy)+ Lead the review of qualityattributes and systems required to support expansion of thebiologics facility to a new, larger location+ Ensure cGMPcompliance, as appropriate for Phase I/II clinical trials, in allareas of TPP+ Provide technical support of compliance aspects inother Fred Hutch departments such as the Vaccine and InfectiousDisease Division (VIDD)+ Foster a culture of strong GMP compliance+Develop and lead a team that meets the QA/QC compliance needs ofthe operation+ Ensure all staff maintains appropriate level oftraining and meets compliance standards+ Establish and effectivelymanage project-specific and departmental annual operating budgetsfor QA and QC+ Establish and maintain Key Performance Indicatorsrelative to quality operations+ Manage and lead partner/clientaudits and FDA inspections+ Ensure supplier quality management iscompleted in+ Oversee the conduct of internal audits in compliancewith FDA guidelines+ Build effective partnerships with departmentheads to help drive the business toward achieving companyobjectives+ Use of strong communication and teamwork skills tobuild relationships with stakeholders+ Evening and/or weekend workmay occasionally be required based on project needMinimumqualifications:+ A Bachelor of Science degree in a scientificdiscipline including pharmaceutical, biologics, or related field+10+ years of relevant experience in the pharmaceutical or biotechindustries or at academic institutions+ Experience at FDA regulatedmanufacturing sites within Quality Operations with demonstratedknowledge of GMPs and compliance requirements+ At least 5 years ofdirect supervisory experience of technical/quality professionalsand in providing guidance, mentorship and support to direct reportsso that they can best manage their teams and projects+ Expertknowledge of FDA regulations, GMP systems and operationalexcellence required for the manufacture of therapeutic products+Demonstrated ability to perform long-term project planning withmeaningful timelines and budget forecasting+ Proven leadership andcoaching skills with emphasis on people development+ Ability toprioritize multiple tasks, work under various timeline pressures,and drive tasks to completion+ Must be able to communicateeffectively in a diverse team environment in support of team goals+Must demonstrate solid time management and organizational skills,with good verbal and written communication.+ Experience with basicMicrosoft Office software (Word, Excel, Visio, etc.)+ Must be ableto don and wear appropriate clean room attire and have the abilityto wear all required Personal Protective Equipment (PPE)+ Must havethe ability to stand for long periodsPreferred qualifications:+ AMS or PhD degree with equivalent professional or academicexperience+ Experience in cell therapy applications with T-cellsand stem cells+ Knowledge of FACT accredidation+ 15+ years ofexperience in Quality+ 10+ years of supervisory/managementexperienceWe are proud to be an Equal Employment Opportunity (EEO)and Vietnam Era Veterans Readjustment Assistance Act (VEVRAA)Employer. We are committed to cultivating a workplace in whichdiverse perspectives and experiences are welcomed and respected. Wedo not discriminate on the basis of race, color, religion, creed,ancestry, national origin, sex, age, disability (physical ormental), marital or veteran status, genetic information, sexualorientation, gender identity, political ideology, or membership inany other legally protected class. We are an Affirmative Actionemployer. We encourage individuals with diverse backgrounds toapply and desire priority referrals of protected veterans. If dueto a disability you need assistance/and or a reasonableaccommodation during the application or recruiting process, pleasesend a request to our Employee Services Center athrops@fredhutch.org or by calling 206-667-4700.ID: 17455ExternalCompany URL: redhutch.org/careersStreet: 1100 Fairview Ave N

Keywords: Fred Hutchinson Cancer Research Center, Seattle , Head of Quality, Other , Seattle, Washington

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Keywords: Amazon Shopper, Kirkland , Head of Quality, Other , Kirkland, Washington

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