Sr. Manager Audit, Gcp Auditor
Company Name:
Otsuka
About Otsuka America Pharmaceutical, Inc.
Otsuka America Pharmaceutical, Inc. (OAPI) is an, innovative, fast-growing healthcare company that commercializes Otsuka-discovered and in-licensed products in the U.S. With a strong focus on neuroscience, oncology, cardio-renal and medical device, OAPI is dedicated to improving patient health and the quality of human life. OAPI is part of the Otsuka Group companies. For more information, visit www.otsuka-us.com.
Senior Auditor Clinical Quality Management assures the proper planning, conduct and reporting of clinical quality management audits and support regulatory inspections. Provides guidance and shares expertise with Otsuka staff in interpreting clinical development regulations and Good Clinical Practice (GCP) guidelines. Assure timely execution of the complete Audit Schedule Proven ability to manage projects/teams of significant scope and complexity, while meeting all deliverables and timelines
Independently prepares for and conducts routine/directed clinical investigator site audits and External Service Provider audits (CRO audits, SMO audits, laboratory audits bio-analytical laboratory audits, software vendor audits, packaging facility audits) domestically and internationally. ), as assigned.
Independently conducts internal systems audits of various departments and procedures, including Pharmacovigilence (PV), as assigned.
Prepares audit reports independently, with review by CQM management as necessary.
Prepares and delivers internal and external presentations, as assigned, with review by CQM management.
Reviews the audit reports of contracted auditors, and forwards to CQM management for final review.
Suggests internal and external audit targets to CQM management.
Identifies opportunities for GCP and business process controls to assure high quality standards for GCP systems/processes and clinical safety and pharmacovigilance compliance with company policies and prevailing government regulations.
Assures completion of Corrective Actions Preventive Actions (CAPA) identified via the audit process.
Works in conjunction with the CQM management to assure coordination of effort within the department and with external contracted staff to assure compliance throughout the drug development process.
Presents CQM concerns to OPDC management, functional area representatives, and external OPDC customers as required, which may include other Otsuka organizations.
Provides guidance and shares expertise in the interpretation of clinical development regulations and Good Clinical Practice (GCP) guidelines, conducts and reports results of clinical quality management audits, prepares for and manages regulatory inspections.
Meets with multifunctional representatives and assures departmental representation at various OPDC projects/initiatives.
Acts as CQM liaison to one or more functions within OPDC.
Performs activities that support overall departmental goals and objectives.
Bachelor's degree in life science and 3-5 years of experience in regulated worldwide clinical drug, biologic or device development
minimum of three (3) or more years of direct Clinical Quality Auditing experience is required
Strong knowledge of Good Clinical Practice principles, global regulations regarding clinical development, auditing techniques, and government regulatory inspection procedures
Strong computer skills of MS Office applications (Word, Excel, PowerPoint Outlook)
Knowledge of applying organizational policy or procedures to a variety of situations
Project management experience is preferred
Travel (approximately 40-50%), both domestic and international in nature
PI87956881
Apply Here : https://external-otsuka.icims.com/jobs/6700/mgr-clinical-quality-management/loginEstimated Salary: $20 to $28 per hour based on qualifications.
Otsuka
About Otsuka America Pharmaceutical, Inc.
Otsuka America Pharmaceutical, Inc. (OAPI) is an, innovative, fast-growing healthcare company that commercializes Otsuka-discovered and in-licensed products in the U.S. With a strong focus on neuroscience, oncology, cardio-renal and medical device, OAPI is dedicated to improving patient health and the quality of human life. OAPI is part of the Otsuka Group companies. For more information, visit www.otsuka-us.com.
Senior Auditor Clinical Quality Management assures the proper planning, conduct and reporting of clinical quality management audits and support regulatory inspections. Provides guidance and shares expertise with Otsuka staff in interpreting clinical development regulations and Good Clinical Practice (GCP) guidelines. Assure timely execution of the complete Audit Schedule Proven ability to manage projects/teams of significant scope and complexity, while meeting all deliverables and timelines
Independently prepares for and conducts routine/directed clinical investigator site audits and External Service Provider audits (CRO audits, SMO audits, laboratory audits bio-analytical laboratory audits, software vendor audits, packaging facility audits) domestically and internationally. ), as assigned.
Independently conducts internal systems audits of various departments and procedures, including Pharmacovigilence (PV), as assigned.
Prepares audit reports independently, with review by CQM management as necessary.
Prepares and delivers internal and external presentations, as assigned, with review by CQM management.
Reviews the audit reports of contracted auditors, and forwards to CQM management for final review.
Suggests internal and external audit targets to CQM management.
Identifies opportunities for GCP and business process controls to assure high quality standards for GCP systems/processes and clinical safety and pharmacovigilance compliance with company policies and prevailing government regulations.
Assures completion of Corrective Actions Preventive Actions (CAPA) identified via the audit process.
Works in conjunction with the CQM management to assure coordination of effort within the department and with external contracted staff to assure compliance throughout the drug development process.
Presents CQM concerns to OPDC management, functional area representatives, and external OPDC customers as required, which may include other Otsuka organizations.
Provides guidance and shares expertise in the interpretation of clinical development regulations and Good Clinical Practice (GCP) guidelines, conducts and reports results of clinical quality management audits, prepares for and manages regulatory inspections.
Meets with multifunctional representatives and assures departmental representation at various OPDC projects/initiatives.
Acts as CQM liaison to one or more functions within OPDC.
Performs activities that support overall departmental goals and objectives.
Bachelor's degree in life science and 3-5 years of experience in regulated worldwide clinical drug, biologic or device development
minimum of three (3) or more years of direct Clinical Quality Auditing experience is required
Strong knowledge of Good Clinical Practice principles, global regulations regarding clinical development, auditing techniques, and government regulatory inspection procedures
Strong computer skills of MS Office applications (Word, Excel, PowerPoint Outlook)
Knowledge of applying organizational policy or procedures to a variety of situations
Project management experience is preferred
Travel (approximately 40-50%), both domestic and international in nature
PI87956881
Apply Here : https://external-otsuka.icims.com/jobs/6700/mgr-clinical-quality-management/loginEstimated Salary: $20 to $28 per hour based on qualifications.
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