Global Quality Manager- Good Clinical Practice (GQM-GCP)
Location: Princeton, New Jersey
Type: Full Time
Required Education: 4 Year Degree
Internal Number: R361
The Manager of Global Quality Management – Good Clinical Practice (GQM – GCP) reports directly to the Associate Director of GQM-GCP and is considered to be a position of increased responsibility within the function.
The candidate will be responsible for managing and conducting Good Clinical Practice (GCP) audits for clinical trials including clinical investigator sites, internal systems, Trial Master Files (TMFs), Clinical Study Reports (CSRs) and processes and may support external service provider audits. Responsibilities include managing timeliness of audit reporting and corrective and preventive actions (CAPAs) review to resolution, supporting escalation, investigation and resolution of Quality Issues / Events and potential GCP serious breaches, GQM-GCP quality engagement member of a Study Team and/or Otsuka and Global Quality initiatives, performing risk assessments of clinical trials and ensuring process enhancement of GQM-GCP audit tools, procedures and processes. the candidate will manage and support GCP inspection readiness activities within their assigned study teams and may be involved in GCP regulatory authority inspections. The candidate should also be open to additional training as deemed applicable (i.e. GVP, Document Management etc.).
Manage and conduct the GCP audit program for assigned clinical trials;
Conduct and manage audits of clinical investigator sites, CSRs, TMFs, internal systems and processes. May conduct or support routine and/or directed audits of External Service Providers (ESPs), such as Clinical Research Organizations (CROs), etc. Responsibilities for audits include but are not limited to the preparation, conduct and timely reporting of audits / assessments;
Manage Inspection Readiness activities, support sponsor/clinical investigator site/external service provider regulatory authority inspections and/or external audit support.
Review and determine (independently or within a committee) adequacy of CAPA responses and ensure completion of CAPA actions resulting from audits, inspections and /or Quality Events (QEs).
Proactively support, as an Audit and Engagement Representative, one or more Otsuka business functions and/or project teams such as Clinical Management, Global Clinical Development, Data Management and Biostatistics.
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 GCP guidelines,
Properly escalate issues and risks to the Otsuka business to GQM Leadership and perform activities that support overall departmental goals and objectives.
May manage contingent worker(s) (indirect reports) who are responsible for all activities within the GQM – GCP team;
Other projects may be assigned, as necessary
Strong knowledge of Good Clinical Practice principles, global regulations regarding clinical development, auditing techniques, document management and government regulatory inspection procedures
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
Education / Experience:
Bachelor's degree in a scientific discipline
8 + years of experience in regulated worldwide clinical drug, biologic or device development
5 + years of GCP auditing and/or Quality management experience preferred
At our core is perseverance, a fierce determination to overcome any obstacle regardless of setbacks, on behalf of patients and their loved ones. We place greater value on what we can achieve together than on what we can do alone because the needs of those we serve always come first. We will not be bound by doing what’s been done before. Instead, we free ourselves from preconceived notions to discover solutions that advance patient care. Our mission is clear: Otsuka-people, creating new products for better health worldwide.