|Global Quality Manager|
Company: Otsuka Pharmaceuticals
Location: Princeton, NJ
Employment Type: Full Time
Date Posted: 05/18/2021
Expire Date: 06/18/2021
Job Categories: Biotechnology and Pharmaceutical
Global Quality Manager |
The Global Quality Manager (GQM) is considered to be a position of increased responsibility within the Global Clinical Quality function. He or she will be responsible for the GCP and/or GVP auditing internal and external entities
In addition, he or she will represent GCQ as a quality engagement member of a Study Team and/or Otsuka and Global Quality initiatives.
The Global Quality Manager may also support Quality operations within the larger Global Quality Management group. He or she would 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.
The Global Quality Manager may manage contingent worker(s) (indirect reports) who are responsible for all activities within the GCQ team. He or she would be responsible for independently preparing for conducting and authoring audit/assessment reports for global clinical Trial Master Files and Pharmacovigilance System Master files.
He or she may be asked to support routine and directed clinical investigator site audits, External Service Provider and CRO audits, internal clinical/PV process audits both domestic and international as assigned. He or she would also independently or within a committee review and determine acceptability of CAPAs. He or she would also be responsible for managing Inspection Readiness activities and regulatory authority inspection and/or external audit support.
He or she would be working with GCQ colleagues, assists in the follow-up and escalation process for Corrective Actions Preventive Actions (CAPA) identified via the audit process, as well as act as a GCQ Audit and Engagement Representative to one or more Otsuka business functions and/or project teams such as CM, GCD, DM and Stats.
He or she will drive the optimization and/or execution of assigned GQM operational responsibilities, prepare and deliver internal and external presentations (as assigned), independently provide GCP guidance and shares expertise in the interpretation of clinical development regulations and Good Clinical Practice (GCP) guidelines, properly escalate issues and risks to the Otsuka business to GQM Leadership, and perform activities that support overall departmental goals and objectives.
* 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 organizational policy or procedures to a variety of situations
* Project management experience is preferred
Travel (approximately 30-50%) both domestic and international in nature
* 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
Come discover more about Otsuka and our benefit offerings; https://www.otsuka-us.com/careers-join-otsuka.
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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