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Manager, QA Product Release

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Company :
Eisai US

Location :
Exton, Pennsylvania

Expiry Date :
Fri, 18 Dec 2020 23:59:59 GMT

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Description :
At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai’s human health care (hhc) mission. We’re a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world’s most widely-used treatment for Alzheimer’s disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you. Job Summary The QA Manager, Product Release, provides compliance leadership for product and material batch release cGMP, SOPs and specifications. Will lead multi-discipline groups to support and execute company directives, policies, processes, procedures, and metrics to assure program, customer, and regulatory requirements are met. The QA Manager, Product Release, leads stakeholders in handling of issues, managing complex problems and development and implementation of preventive or corrective actions. Will review CAPAs/ Investigation Records to assure that trends or systems issues are identified and advise on development and implementation of preventive or corrective actions. Drive continuous quality improvement through communication/training, waste reduction, and mistake-proofing. Overall responsibility for a workforce geared toward quality and continuous improvement. Essential Functions – Lead Product and Material Release Programs, including the approval of specifications(40%) – Lead Material Review Board (20%) – Develop and Lead Investigation Review Board (10%) – Develop and Lead Quality Management Review Program (10%) – Review CMC documentation, as needed (5%) – Maintain up-to-date Standard Operating Procedures (SOP) (5%) – Develop and Maintain Metrics for group (5%) – Support TrackWise system upgrades, as needed (5%) Requirements – BS in Chemistry, Chemical Sciences, Biochemistry or equivalent education – Minimum 5 years of biopharmaceutical experience, including 3 years in a quality/regulatory function required – Minimum Two (2) years experience managing quality processes required – Prior Clinical experience is required, Commercial experience is desired – Ability to work under challenging deadlines and be accountable for completing work within specific project timelines – LIMS/SAP/Trackwise experience desired – Strong detail orientation, organization and focus on quality work product – Proven ability to establish new quality systems and optimize existing systems, review documentation, processes and procedures, identify issues, assess compliance, communicate findings clearly and succinctly – Continuous Improvement experience preferred Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans. Please Click On The Following Link For More Information Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Right To Work E-Verify Participation