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Assoc Dir QA GCP CSPV in Bernards, NJ at DSI

Date Posted: 3/25/2019

Job Snapshot

Job Description

Join a Legacy of Innovation 110 Years and Counting!

With over 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for hypertension and thrombotic disorders, under the Group’s 2025 Vision to become a “Global Pharma Innovator with a Competitive Advantage in Oncology,” Daiichi Sankyo research and development is primarily focused on bringing forth novel therapies in oncology, including immuno-oncology, with additional focus on new horizon areas, such as pain management, neurodegenerative diseases, heart and kidney diseases, and other rare diseases.

Job Summary
The Associate Director, CSPV QA develops, leads, manages, performs, and prioritizes the aspects of a fully functional CSPV QA audit program for pivotal clinical development projects and post-marketing pharmacovigilance activities that will assure the processes of the Clinical Safety Pharmacovigilance (CSPV) and the DSAC Post-Marketing group and its partners, affiliates, and vendors are compliant with regulatory requirements. The Associate Director, CSPV QA also consults with study teams and CSPV staff, providing appropriate interpretation and training of regulatory requirements with expertise focus on CSPV. In addition, the incumbent represents DSI QA on cross-functional, local and global taskforces as designated and generates metrics as requested; this includes leadership and key contributions to Global PV QA initiatives. The incumbent is involved in the selection of QA-CSPV audit consultants and oversees their qualification and training implementation which may include co-audits and final review of audit reports. As needed, the Associate Director, CSPV QA may support or coordinate GCP QA activities of identified clinical trial projects from a GCP QA perspective including audits and consultation, regulatory inspections, and other GCP QA activities including submission support.

Responsibilities

Audit Program: Develops, leads, manages, performs, and prioritizes all types of audits in the audit program of Clinical Safety Pharmacovigilance that encompasses the systems and processes of the Daiichi Sankyo’s Clinical Safety Pharmacovigilance (CSPV) and the PV activities of the DSAC Post-Marketing group and its partners, affiliates, and vendors. Generates and updates a risk-based CSPV audit program documentation for a prioritized five year audit master schedule and ensures up-to-date GCP audit programs for assigned projects. Ensures the conduct of audit related activities from preparation to writing and distribution of reports, including the reporting of periodic metrics. Provides guidance and information to Consultant Auditors to ensure the performance of audit activities and assists in the review of Consultant Audit Reports. Ensures that all PV related activities performed by the DSAC Post-Marketing group can withstand scrutiny from regulators. As required, may also contribute to the scheduling and conduct of audits for clinical investigator sites (phases I to IV), GCP internal systems, and vendors of clinical studies.

Cross-Functional and Global Team Participation: Collaborates with global teams in the development and implementation of CSPV QA objectives, in the preparation of risk-based audit programs, periodic metrics, and in the support and management of Affiliates. Leads or is a key contributor to Global PV-QA initiatives. Based on risk considerations, elevates issues to senior management. Also acts as an internal consultant by liaising with DS departments regarding global conformance with CSPV/GCP requirements, and internal standards, and the pro-active integration of quality and process improvement. Interprets relevant regulations and applies them to practical clinical development programs and post-marketing programs.

Consultation and Training: Addresses escalated issues, organizes intelligence collection from various sources, and leads the presentation of collected intelligence within the CSPV QA team. Also consults with cross-functional management to identify training needs. Represents CSPV-QA on cross-functional and global taskforces and committees. Interprets relevant regulations and applies these to practical Clinical Research and Development and Clinical Safety Pharmacovigilance programs.

Corrective and Preventative Action (CAPA Plans): Maintains, verifies, assesses, and tracks CAPA documentation and commitment implementation. Evaluates impact of CAPA implementation when appropriate. Generates requests and reminds relevant parties of follow-ups. Handles escalation of CAPA follow-ups.

Regulatory Inspections: Responsible for leading and managing all aspects of CSPV regulatory inspections (internal) at DS and DSAC facilities and supports PV inspections as necessary at service providers, Partners, and Affiliates. Conducts review, coordinates, tracks responses to PV inspections, and ensures supporting documentation is complete and filed appropriately. Verifies and tracks implementation of CAPA commitment implementation. As needed, may support or coordinate all aspects of GCP regulatory inspections (internal) at DS facilities including service providers, investigator sites.

Development Policies, Procedures, and Standards (SOPs, QMS): Creates and reviews specific QA procedural documents and assures compliance with CSPV/GCP guidelines and regulatory requirements to protect the safety and rights of human subjects. Coordinates and tracks milestones for timely procedural document review, approval, and effectiveness dates.

Qualifications

Education and Experience
  • B.S. degree in scientific, health care, or related discipline; and/or background in Medical Health Profession (RN, Medical technologist, etc.)
  • Five years’ pharmaceutical experience, at least two of which are in the CSPV QA area

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.