Auditor, QA GCP in Bernards, NJ at DSI

Date Posted: 2/6/2018

Job Snapshot

Job Description

Join a Legacy of Innovation 110 Years and Counting!

Daiichi Sankyo, Inc. is the U.S. subsidiary of Daiichi Sankyo, Co., Ltd. The Company currently markets therapies in hypertension, dyslipidemia, diabetes, acute coronary syndrome, thrombotic disorders, stroke risk reduction, opioid-induced constipation, IV iron therapy and metastatic melanoma.

Job Summary

The QA GCP Auditor prepares and supports the conduct, reporting, and follow-up on audits of Phase I-IV clinical studies to assure that all studies performed by Daiichi Sankyo Pharmaceutical Development are in compliance with GCP Guidelines and DSPD quality standards. Participates in audits of all phases of clinical development and also conducts audits independently. In this role you will contribute to the management of the information flow between the QA GCP group and its customers in the Clinical Operations and Clinical Development Departments relative to specific projects of the audit program. The Auditor will escalate issues as appropriate to line management and will have functional support activities and tasks assigned by the QA GCP Director.

Responsibilities

Audit Program: Prepares, schedules, conducts, and reports investigator site and document audits that encompass Phase I through IV studies of clinical development, and supports lead auditor during vendor and systems audits to ensure compliance with applicable regulations, GCP guidelines, and company quality standards. Enters data and supports the maintenance of the audit management database, distributes and files audit information. Perform QC of audit reporting and tracking documentation.

Corrective and Preventative Action (CAPA) Plans, Tracking and Communication Flow: Generates Corrective and Preventive Action (CAPA) plan requests, audit related correspondence, and memos. Maintains QA tracking logs including tracking of CAPA commitments arising from any source: e.g. internal DS audits, and Regulatory Inspections. Remind of due-dates of inspection and audit CAPAs as required. Assists in the management of the information flow between the QA GCP group and its customers such as Clinical Operations/ Development Department relative to specific activities of the audit program, e.g., distribution and archiving of audit reports, sends CAPA request reminders, inquiries for evidence of CAPA implementation, and Close-out Memos.

Consultation and Training: Supports and documents consulting activities and training of internal teams on quality standards and procedures. Supplies audit information and procedural training material to consultant auditors. Document and files consultant and internal team training. Supports the function’s efforts to collect and file intelligence related to regulatory requirements, guidance, and industry standards.

Regulatory Inspections: Supports the facilitation of all aspects of GCP regulatory inspections (internally). Assists in the preparation, coordination, and tracking of document requests, responses, and supporting documentation during inspections; tracks responses and implementation of remediation after inspections.

Development of Policies, Procedures, and Standards (SOPs, QMS): Participates in creating and reviewing Quality Assurance procedural documents including final QC and formatting.

Support of Joint audits with the Japan, EU and other DS QA Groups: Generates GCP-QA audit tools. Assists in the preparation, documentation, reporting, distribution, and follow up of joint audit activities.

Qualifications

Education and Experience
  • Minimum Associates degree in scientific, health care, or related discipline; and/or background in Medical Health Profession (RN, Medical technologist, etc.) B.S. degree preferred.
  • One to two years pharmaceutical experience preferred
  • Ability to travel up to 25%
Daiichi Sankyo, Inc., is an equal opportunity/affirmative action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.