Vice President, Quality Assurance Head in Bernards, NJ at DSI

Date Posted: 9/2/2018

Job Snapshot

Job Description

About Daiichi Sankyo Cancer Enterprise

The mission of Daiichi Sankyo Cancer Enterprise is to leverage our world-class, innovative science and push beyond traditional thinking to create meaningful treatments for patients with cancer. We are dedicated to transforming science into value for patients, and this sense of obligation informs everything we do. Anchored by three pillars including our investigational Antibody Drug Conjugate Franchise, Acute Myeloid Leukemia Franchise and Breakthrough Science, we aim to deliver seven distinct new molecular entities over eight years during 2018 to 2025. Our powerful research engines include two laboratories for biologic/immuno-oncology and small molecules in Japan, and Plexxikon Inc., our small molecule structure-guided R&D center in Berkeley, CA.

Job Summary

The Vice President (VP) of Daiichi Sankyo Inc., Quality Assurance is responsible for the activities of all GXP Quality Assurance activities at Daiichi Sankyo Inc. and leading the Global RD/PV-QA Organization:

Global Head of RD/PVQA: Coordinating and leading the global quality organization for GCP-QA, GLP-QA, and Pharmacovigilance QA. The VP is responsible for driving the development of Global Policies and Procedures assuring that there is worldwide compliance with company policies for GCP/GLP/PV-QA and the laws and regulations governing drug discovery and development in all countries where we study our products.

DSI Quality Assurance Head: (1)Administrative and functional head of GCP and PV Quality Assurance, overseeing the GCP/GLP-QA, GMP-QA, Clinical Safety and Pharmacovigilance-QA, QA Computer System Validation (CSV) and Coordination groups who assure the creation and maintenance of compliant world-class development practices for DSPD. In this role, the VP of DSI QA has the responsibility for the functional support of the QA GMP group assuring that all GMP facilities in the Americas (currently including DSI, LPI and DSBR) have effective quality systems and an uninterrupted supply of compliant products to the marketplace.

VP of DSI QA directly reports to Global Head of QA. This position administratively reports DSI representative who is assigned by DSI President, and attends DSPD and DSAC leadership committees as appropriate to contribute DSI business success.

This position is also critical to assure regulatory agencies, our customers, stakeholders, suppliers, colleagues, and internal colleagues recognize us as trusted partners and leaders in compliance, productivity and customer service.

Responsibilities
  1. VP of DSI QA directly reports to Global Head of QA. VP of DSI QA is a full partner with the global functional groups that research, develop and regulate DS products by establishing and maintaining a quality oriented organization that assures sustainable compliance with the laws and regulations governing drug discovery and development as well as the validation of computer based systems to regulatory standards. This is critical to assure that regulatory agencies, our customers, stakeholders, suppliers, and colleagues recognize us as trusted partners and leaders in compliance, productivity and customer service and will facilitate the rapid approval of regulatory filings and assure human protection.
  2. As the Global Head of RD/PV-QA in the Global QA Organization, to lead the Quality Assurance aspects of GCP, GLP, and Pharmacovigilance to assure effective global communication and performance of quality responsibilities. This includes objective setting, ensuring appropriate management, communication and escalation of metrics and issues, maintaining the Quality System and leading RD/PV-QA Global meetings. Accountabilities include:
  • Communicating frequently with the global quality leadership at DS QSM Unit, DSPD Leadership team, R&D locations, CROs, CMOs and sites.
  • Providing on-site support, for instance during regulatory inspections, to assure clear communications to and support from headquarters, including the Global Head of Quality Assurance, Supply Chain (SC), Pharmaceutical Technology (PT) and when necessary the CEO.
  • Assure direct support to sites to complete investigations into potentially serious matters.
  • Provide timely and proper responses when urgent quality matters arise.
  1. To establish, maintain, standardize, and manage a GxP Quality Management System (QMS) for DSI (DSPD & DSAC) covering all GxP activities and developmental studies and products for all DSI operations in accordance with Global GxP QMS in Daiichi Sankyo. This includes auditing and troubleshooting at suppliers of internal and contracted GMP, GCP, GLP, CSPV-QA, Computer System Validation (CSV) and GxP Training goods and services. This also includes communicating frequently with the US RD Management Team and DSAC Leadership team.

    By a combination of direct authority and organizational influence the VP will assure that the product supply and global study performance is sound and defensible in order to maintain world-class performance.

    Decisions made have a direct impact on quality of our products and studies and submissions and may prevent serious health hazard, negative regulatory action, and adverse publicity. Negative regulatory action is up to and including rejection of regulatory filings, product seizure, or recall.
  2. Oversee and support the QA GMP group in order to assure the maintenance of effective GMP quality systems across the Americas region.

    Oversee quality project management for all GxP QA activity in DSI in order to constantly improve the level of quality systems and standardize the QMS.

    The VP is responsible to report to and collaborate with the Global Head of QA with close relationships and reporting in timely manner.
  3. Oversee the development and maintenance of global and local procedural documents by overseeing the activities of the DSPD SOP Committee and the Global R&D SOP Committee in order to assure that uniform and appropriate procedures are implemented, maintained and followed.
  4. Employ, maintain, develop, and motivate staff to develop leaders who will maintain the company’s quality and be capable of long and short-term growth within the company.
  5. Prepare and adhere to annual departmental budget (magnitude to be determined) in order to manage expense expectations and provide fiduciary oversight to the quality function
Qualifications

Education
  • A minimum of a Bachelor’s Degree in chemistry, biology, pharmacy, or related scientific field. Advanced degree desirable but not required.
Experience
  • At least 15+ years of related experience in the pharmaceutical industry including significant experience in leading a global Quality organization.
  • Extensive experience in pharmaceutical development and/or commercial development operations including first-hand knowledge of clinical distribution, clinical operations, QC/QA, and regulatory compliance.
  • Oncology Experience preferred.
  • Direct success with international regulatory authorities.
  • Managing within a global organization, embracing diverse cultures and employees.
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.