Director, GVP, GCP, GLP, & CSV Inspection Readiness

Company: Otsuka Pharmaceutical Co., Ltd
Location: Aliso Viejo
Posted on: March 17, 2023

Job Description:

Job Responsibilities:

• Developing and implementing a cross functional inspection management infrastructure from preparation/planning through execution and performing key leadership roles within the Global Quality Management (GQM) team
• Developing and maintaining a comprehensive inspection readiness program, sustainable for increasing inspections across GxP and a wide range of regulatory authorities
• Integrating cross-functional stakeholder organizations into the inspection readiness
• Drive the periodic review process for CSV application to ensure compliance
• Responsible for compiling and reporting of inspection compliance metrics at appropriate levels of management review
• Administratively and logistically facilitate and manage inspections and GVP partner audits hosted by Global Quality Management (GQM)
• Own inspection management tools including ACE, Intralinks, Box, SFTP, as well as MS Teams and manage logistics for inspection preparation/management
• Maintain inspection readiness artifacts including but not limited to: Inspection Distribution List; Inspection Presentations; Inspection Organization Chart; Inspection Training
• Help administratively facilitate inspection management response process
• Ensure timely data entry as relates to audit / inspection conduct into Inspection Management System (ACE) and Deviation / CAPA System (TrackWise)
• Knowledge of Quality Document Management and the process flow (Quality Docs, EDMS)
• Responsible for GxP Intelligence and Regulatory Commenting as relates to audit / inspection Management
• Monitor the Otsuka portfolio and perform risk assessment regarding the need of Inspection Readiness activitiesPreferred Qualifications:
  • Advance degree such as Pharm D., MD., or PhD. in the sciences
  • 15 or more years in multi-national biopharmaceutical industry that includes performing GVP, GCP, & GLP audits extensively, and inspection readiness activities
  • Experience hosting or participating in GVP partner audits and regulatory inspections
  • Knowledge of GVP, GCP, & GLP global regulations as they relate to Clinical Development, Drug Safety and Drug Development
  • Understanding of being risk based focused and prioritizing work based on Risk Management methodologies
  • Detail-oriented with experience in Quality / Compliance functions
  • Advanced computer skills, including knowledge of working with SharePoint Online, MS Teams, Smartsheet and Tableau
  • Excellent communication skills, both written and oral. Ability to effectively present information to all levels of the organization worldwide and across affiliates
  • Work in a team matrix environment and independently interact with various levels of senior management#LI-remote #MZ1Come discover more about Otsuka and our benefit offerings;.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.Valid Proof of COVID-19 Vaccination or AccommodationThe COVID-19 Vaccination is mandatory for incoming new hires and employees. Uploading documentation with proof of full vaccination record or an Otsuka approved accommodation will be required during the pre-employment process as permitted by law. New hires must be fully vaccinated unless there is an approved accommodation prior to start date.Statement Regarding Job Recruiting Fraud ScamsAt Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. - They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf.Please understand, Otsuka will never ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment.Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters.To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website .Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: 800-363-5670. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: , -or your local authorities.

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