|Sr Mgr Global Quality Management|
Company: Otsuka Pharmaceuticals
Location: Princeton, NJ
Employment Type: Full Time
Date Posted: 11/27/2021
Expire Date: 01/27/2022
Job Categories: Medical
Sr Mgr Global Quality Management|
Job Description - The Sr Manager, Global Quality Management level is considered to be a position of increased responsibility within the Global Quality Management function. - This role will be responsible for the GCP and/or GVP auditing internal and external entities with a primary responsibility in the auditing of the Master Files (both Trial Master Files and Pharmacovigelence System Master Files). - In addition, this role will represent CQM as a member of a Study Team and/or Otsuka and Global Quality initiatives. - This role may also support Quality operations within the Global Quality Management group. who will be responsible for driving the management of assigned activities within the group. - This could include SOP Management, CAPA Management, Deviation Management, SOP/GxP related Training and Inspection Readiness and support in addition to other assigned Quality tasks. - Manager for a group of contingent workers (indirect reports) who are responsible for all acti vities within the Document Management Services function (i.e. File Room). - Responsible for ndependently preparing for conducting and authoring reports for global clinical trial master files and Pharmacovigelence System Master files. - May be asked to support routine and directed clinical investigator site audits, External Service Provider audits (CRO audits, SMO audits, Vendors), internal process audits both domestic and international as assigned - Independently or within a committee reviews and determines acceptability of CAPAs - Drives or participates in the optimization and/or execution of assigned GQM operational responsibilities - May be responsible for oversight of Document Management - Prepares and delivers internal and external presentations, as assigned - Working with CQM colleagues, assists in the follow-up and escalation process for Corrective Actions Preventive Actions (CAPA) identified via the audit process - Independently provides GCP guidance and shares ex pertise in the interpretation of clinical development regulations and Good Clinical Practice (GCP) guidelines - Inspection Readiness activities and regulatory authority inspection and/or external audit support - Properly escalates issues and risks to the Otsuka business to GQM Leadership - Acts as a Global Quality liaison to one or more Otsuka business functions and/or project teams - Performs activities that support overall departmental goals and objectives Knowledge/Skills - Strong knowledge of Good Clinical Practice principles, global regulations regarding clinical development, auditing techniques, document management and government regulatory inspection procedures - Good Pharmacovigilance Practices (GVP) experience preferred - Open to additional training as deemed applicable (i.e. GVP, Document Management etc.) - Strong computer skills of MS Office applications (Word, Excel, PowerPoint Outlook...) - Proficiency with TrackWise is preferred - Knowledge of applying organ izational policy or procedures to a variety of situations - Project management experience is preferred - Travel (approximately 30-50%) both domestic and international in nature Education - Bachelor's degree in life science and 8 plus years of experience in regulated worldwide clinical drug, biologic or device development - More than 4 years of GCP and/or GVP auditing and/or Quality management experience preferred
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Disclaimer: This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to their protected veteran or disabled status, or any protected status.
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