Manager, Quality Assurance
Manager, Quality Assurance
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$ 123930 - 160380
1 Vacancy
Job Description
Were here for one reason and one reason only to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. Weve made incredible scientific breakthroughs and our pioneering personalized CAR Tcell therapies have changed the paradigm. But were not finished yet.
Join Kite as we make even bigger advances in cancer therapies and help shape where our business and medical science goes next.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future you are the key driver in evolving our culture and creating an environment where every employee feels included developed and empowered to fulfil their aspirations. Join Kite and help create more tomorrows.
Job Description
Everyone at Kite is grounded by one common goal curing cancer. Every single day we seek to establish adirectline between thatpurposeand our daytoday work.
Kite is seeking a highly motivatedindividualcontributor to join our External Quality team as Manager Quality Control. This role will report to the Director External Quality. Scope of the External Quality group includes Quality oversight of contractserviceproviders such as manufacturingorganizations(CMOs) contract testing labs (CTLs) and Qualitysupportfor Partnerships spanning clinical and commercial operations within the cell therapy space.
The Manager will have opportunities to work andshareknowledge with partners across Kites Global Technical Operations (e.g. Quality ControlAnalyticalDevelopment Process Development Quality Manufacturing Supply Chain and Regulatory) as well as international partners. Theideal candidatewill have aexcellenttechnical skills (knowledge of one or more of the following: cell therapy bioassaysviralvector and testing operations) Quality and Compliance background (Biologics Drug regulation) andunderstandingof the drug development lifecycle.
Responsibilities:
Assist External Quality Director to oversee andsupportoneor more external testing partners andimplementationofdaytoday External Quality operationalresponsibilitiesrelatedto the partnership.
Supportof strategic alliance partners onsuccessfulproductlaunch including but not limited to establishing and managing Joint Quality Councilscommunicatingandhelping partners to assess impact of changes tech transfer product harmonization fielding regulatory inquiries andsupportingthecrossfunctionalteamon all Quality related matters.
Review and data analysis/trending tounderstandtheexternal testing partner issues and provide recommendations in technicalresults.
Initiate review and/or approval of GMP records and documents (both internal and external) including but not limited to method SOP investigations corrective actionschangecontrolsprotocols and reports.
SupportExternalQuality Director to perform data verification including but not limited to annual Product Quality Reviews filings Quality Agreements.
Overseeingof contract testing laboriginaldatareport critical issues or the progress and data relating toviralvectorrelease.
Supportingregulatoryagency inspections for all inquiries relating to contract testing laboratory operations.
UnderstandGileadbusiness model andorganizationpriorities.
Up to 10% travel
Basic Qualifications:
Masters Degree and 4years biopharmaceutical/celltherapy Quality Controlexperience OR
Bachelors Degree and 6years biopharmaceutical/celltherapy Quality Control experience OR
High School Degree and 11years biopharmaceutical/celltherapy Quality Control experience
Preferred Qualifications:
Experience working with Quality Assurance
Experience working with CMOs and/or CTLs and/orsupporting alliances/partnerships
Must be able to work on multiple projects simultaneously and demonstrateorganizationprioritizationandtime managementproficiencies
Diplomacy skills and ability to assess performance and proactively identify and mitigate risks
Experience withcollaboratingin acrossfunctionalworkingmodel withsupportfromfully and partiallydedicatedresources;ability tomanagethroughinfluence.
Knowledge and experience across various GXP settings preferably in cell therapy biologics biopharmaceuticals
Exhibitdirectionskillsand strategic networkbased thinking.
Experience withdirectRegulatoryAgency (e.g. FDA)interaction.
Experience auditing and performing duediligenceassessmentsfor CMOs/CTLs
Experience writing evaluating and closing investigations CAPAs andChangeControlrecords
International partnership experience (e.g. CMO CTL and/or Strategic Partners)
Culturalsensitivityandunderstandingofregional and global perspectives/marketplace
Previous experience in peopledirection
Excellentoral and writtencommunicationskillsin English.
Meaningfulinterpersonalskills open minded to thediverseopinionsofothers and able to lead effectively throughinfluence
Comfortable in afastpacedsmall companyenvironmentwithminimal direction and able to adjust workload based upon changing priorities
Selfmotivateddetailorientedand willing to accept temporaryresponsibilitiesoutsideof initial job description
Does this sound like you If so apply today!
For additional benefits information visit:
Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment and is dedicated to fostering an inclusive work environment comprised of diverse perspectives backgrounds and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race color religion national origin sex age sexual orientation physical or mental disabilitygenetic information or characteristic gender identity and expression veteran status or other nonjob related characteristics or other prohibited grounds specified in applicable federal state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973 the Vietnam Era Veterans Readjustment Act of 1974 and Title I of the Americans with Disabilities Act of 1990 applicants who require accommodation in the job application process may contact for assistance. NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT PAY TRANSPARENCY NONDISCRIMINATION PROVISION Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team. Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion. Please apply via the Internal Career Opportunities portal in Workday.
Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid longterm durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune systems ability to recognize and kill tumors. Kite is based in Santa Monica CA. For more information on Kite please visit . Sign up to follow @KitePharma on Twitter at jobs in the United States:
For more information about equal employment opportunity protections please view theKnow Your Rights poster.
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACTFor Current Kite Pharma Employees and Contractors:
Required Experience:
Manager
Employment Type
Full-Time
