Associate Clinical Quality

Profile

Who We Are BioMarinu2019s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarinu2019s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. DutiesThis position reports to the Director / Supervisor/ Manager/ Senior Manager, Clinical Quality Operations and is responsible for quality oversight for processes relating to the development, manufacture and testing of clinical material made for BioMarinThe responsibilities in the role include the following:Review of GMP documentation from Pilot Plant, CDMOs, Analytical Sciences, including log books, batch records and test records.Issuance of Batch Records for clinical productionReview and approval of procedures and batch records related to early phase programs(Quality, Pilot Plant, Analytical Sciences, other areas).Review and approval of quality system records including change requests, deviations and CAPA for Technical Development (i.e. Pilot Plant, Analytical Sciences, Process Development).Oversee manufacturing and QC adherence to company policies/procedures, regulatory licenses, industry standards, and GMP regulations.SkillsMinimumu00A03u00A0years of experience in a Quality/Compliance/Regulatory settingSound knowledge of cGMPs and equivalent industry regulationsPrior experience with oversight of manufacturing or testing operationsProficiency with computer systems u2013 Microsoft Office SuiteProficiency with database use for example Veeva or other QMS, Benchling or other ELN, LIMS, Oracle or other ERP preferredCollaboration - Ability to work across teams and individuals at various levels in the organization to complete work tasks and activities. Strong follow-up and an ability to relate well to others.Ownership and Accountabilityu2013 Takes accountability for actions, drives results, and able to learn from mistakes. Delivers on promises, goals, and expectations. Makes quality decisions and resolves problems with minimal delay as appropriate. Asks u201Cwhat can I do to help?u201DCommunication- Ability to communicate effectively with peer and managers. Strives for simplicity.u00A0Ability to draft and deliver clear and concise written communications.Planning - Ability to prioritize and ask questions when priorities are not clear. Ability to adapt to changing deadlines and escalate when roadblocks occur. u00A0Able to deliver results despite shifting environment.Customer focus - Partners with customers, looks ahead to predict future customer needs. Manages expectations.EducationBachelor's degree in scienfitic field.u00A0u00A0u00A0u00A0In the U.S, the hiring range for this position is *31* to *50* per hour. The base pay actually offered will take into account internal equity, and may also vary depending on candidateu2019s geographic region, job-related knowledge, skills, and experience amongst other factors. PLEASE NOTE: Absent a Medical or Religious reason that prohibits vaccinations, all our incoming employees must be vaccinated for COVID-19. We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.

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