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Director, Quality Assurance for Quality Control Operations

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

Job Description:

Director, Quality Assurance for Quality Control Operations Company: Lever

Location: Cambridge

Posted on: September 12, 2020

Job Description:

Director, Quality Assurance- Gene Therapy Ultragenyx is acommercial-stage biopharmaceutical company committed to developingand commercializing novel therapies for the treatment of rare andultra-rare genetic diseases. The company has rapidly built adiverse portfolio of small molecules, biologics, gene therapies andnucleic acids to target debilitating genetic diseases for which theunmet medical need is high, the biology for treatment is clear, andfor which there are typically no approved therapies treating theunderlying disease.

Ultragenyx Gene Therapy is headquartered in Cambridge, MA withadditional locations in Woburn, MA. We are looking for exceptionalindividuals who share our passion for developing novel therapies totreat rare diseases and advancing the 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 committedto our hiring process. The health and safety of our employees andprospective employees take priority which means at this time ourprocess will include remote based web-ex video discussions,interviews & onboarding.

POSITION SUMMARY

The Director, Quality Assurance for Quality Control Operationsis primarily responsible for Quality Assurance oversight of theQuality Control (QC) GMP laboratories. This person will beresponsible for providing QA oversight of quality system activitiesrelating to QC such as deviations, change controls, OOS/OOTinvestigations, and document changes. Additional routine activitiesinclude oversight of QC processes such as certificate of analysis,test documentation, vendor management, and management ofcontrols/reference materials. This person will also provide QAreview of equipment validation and method validation. This personprovides critical quality expertise to ensure compliant manufactureand testing of clinical and commercial gene therapies. They willwork closely with the internal QC laboratories and will collaboratewith other departments or laboratories within the Ultragenyxnetwork.

The Director reports to the Sr. Director of Internal CMC QualityAssurance Operations at Ultragenyx Gene Therapy.

Job Responsibilities Actively partners with the Global and SiteLeadership Teams to support GxP operations, company projects andother activities. Informs leadership of critical issues.

Utilize risk management principles to continuously improve QCrelated processes and procedures.

Responsible for QA oversight and management of deviations or outof specifications (OOS) to ensure investigations drive to rootcause and CAPA are sufficient to eliminate repeat occurrence.

Responsible for QA oversight and management of QC related changecontrols to ensure they are properly assessed and implemented withappropriate controls.

Ensure timely and accurate review and approval of certificatesof analysis (CofA) to support batch disposition of clinical andcommercial products.

Ensure QC test documentation and lab results are controlled andmanaged according to documentation standards

Provide QA review for validation activities for new equipmentand method validation.

Support the development and implementation of QC Lab operationprocedures to meet Quality Standards.

Drive or support continuous improvement activities to supportelimination of waste to enable an effective and efficient QCLaboratory. Champion process improvement where applicable.

Promote a culture of quality, operational excellence, andvalue-add.

Prepare reports and present KPI metrics to seniormanagement.

Help maintain a state of continuous inspection and/or auditreadiness for the QC Labs. Participate in responses/correctiveactions to regulatory findings.

Collaborates with the GxP Compliance team for internal audits aswell as external vendor audits as part of the supplier qualitymanagement process. Manages findings, responses and corrections toaddress identified risk.

Will write and review Quality Assurance program policies andprocedures.

Hires, manages and mentors staff, performs performance reviews.Ensures direct reports and their teams carry out their dutiesaccording to GxP principles.

Collaborate across the Ultragenyx network with other labs orteams to share best practices and improve processes.

Work effectively to collaborate with direct teams orcross-functional teams. Clarify priorities as appropriate.

Drive timely and effective decision making. Determine or clarifydecision rights as needed.

Qualifications Minimum B.S. degree in preferably microbiology,chemistry or biochemistry.

A minimum of 12-15 years of experience in biopharmaceutical orbiotechnology based GMP clinical or commercial operations with afocus on Quality Control. Experience with both internal QCoperations and external contract test lab operations ispreferred.

8+ years of direct supervisory experience of technical orquality professionals with demonstrated effectiveness to recruit,hire and train a team as well as provide continued guidance,mentorship and support to staff.

Comprehensive knowledge of FDA and EMA regulations andexperience in US and international regulatory agencyinspections.

Direct experience reviewing and/or authoring CMC sections ofregulatory filings.

Excellent oral and written communication skills with strongtechnical writing experience required.

Demonstrated analytical approach to problem solving and decisionmaking.

Demonstrated ability to manage multiple priorities for complexprojects.

Experience leading continuous improvement efforts.

#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 , Director, Quality Assurance for Quality Control Operations, Other , Cambridge, Massachusetts

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Keywords: Amazon Workforce Staffing, Cambridge , Director, Quality Assurance for Quality Control Operations, Other , Cambridge, Massachusetts

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