Sr Director, QA GCP - Oncology in Bernards, NJ at DSI

Date Posted: 4/6/2018

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 Senior Director, GCP-Oncology is the key GCP-QA partner for Daiichi Sankyo’s Cancer Enterprise (CE) group. This position reports to the VP of Quality Assurance and is accountable for and directs strategic initiatives of high complexity and provides leadership for GCP-QA activities of CE in the Americas region and global program, which encompasses all phases of clinical development.

Designs and drives Quality initiatives and enhances the Quality framework for regulatory Submissions for CE studies, facilitation, and follow-up support to contribute to global/local CE programs. As related to Oncology, drives priorities, directs and coordinates GCP-QA staff to deliver objectives and consults on critical and complex GCP quality and compliance issues that have been escalated and provides leadership and direction for problem solving activities for non-routine QA operational issues. Develops QA talent in the area of GCP; coaches and guides staff on majority of complex decisions. The incumbent also oversees and collaborates with other QA GCP group members for all CE programs to collect GCP-QA metrics and to be accountable for GCP-QA Oncology project management and liaison / stakeholder management. In addition, this position represents a single point of accountability for GCP-QA on CE related cross-functional, local and global taskforces as designated for the development and implementation of GCP-QA objectives related to Risk Management, GCP Quality Issue, Root Cause Analysis, and CAPA management. Further, this position provides support to the creation of Quality Assurance SOPs and policies and works on task forces and quality improvement initiatives. Collaborates with QA functions during the integration of new clinical development ventures. This position escalates issues of elevated risk to Senior Management. Based on business need, position may carry out tasks of other GCP levels.

Responsibilities

1. Partnering with CE to improve Quality: In the capacity of GCP-QA Lead for CE, the role is responsible for driving the successful partnership between CE and GCP-QA. With the goal of driving quality forwards, the role directs strategic initiatives of high complexity and provides leadership for all CE related GCP-QA activities in the Americas region and global program. The role is responsible for proactive liaison with CE and establishing an effective cross-functional and multiregional network to ensure CE business needs are fully met from GCP-QA perspective. Consults with CE management teams to identify and implement opportunities for Quality initiatives and enhances the Quality framework for regulatory Submissions of CE. Leads GCP-QA participation in CE teams of Clinical Research and Development and related functions and assigns GCP-QA members for team support. Represents GCP-QA on CE related cross-functional, local and global taskforces as designated for the development and implementation of GCP objectives related to Risk Management, GCP Quality Issue, Root Cause Analysis, and CAPA management. Directs GCP-QA staff to deliver objectives and guides staff on critical and complex GCP quality and compliance issues.

2. CE Project Management as single point of accountability: Leads and directs CE related QA GCP project and activities. A single point of accountability for CE in QA GCP. Responsible for CE / QA GCP liaison and stakeholder management. Responsible for managing CE QA GCP metrics.

3. Regulatory Inspections: Leads the management of CE related inspection activities pertaining to the preparation, facilitation, and follow-up of GCP regulatory inspections. Liaises with regulatory agencies on GCP Quality Assurance issues with regard to Oncology. Directs inspection response teams and taskforces for complex corrective/preventive action implementation; presents and communicates on remediation status and implementation;

4. Development Policies, Procedures, and Standards (SOPs, QMS): Directs and aligns the creation of GCP-QA’s policies, procedures, QMS elements, and standards. Provides guidance in the creation and review of specific QA specific documents.

5. Selection and Qualification of Consultants and Budget Allocation: Leads the forecasting, planning, selecting and qualifying of GCP-QA consultants for CE projects; develops and allocates project specific QA budgets, and provides input for the QA team budget.

6. Management and Career Development for Personnel: Develops and motivates GCP-QA staff to develop as leaders who will maintain the company’s quality and be capable of long and short-term growth within the company. Acts as coach/mentor at the functional level. Develops GCP-QA Oncology talent and delivers Quality training for CE personnel.

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.)
  • Minimum ten plus years pharmaceutical experience required
  • Global experience and leadership experience required, with experience in Quality Assurance in the oncology therapeutic area
Competencies
  • Ability to manage multiple, high priority projects and timelines.
  • Ability to communicate and maintain collaborative relationships effectively with key internal and external stakeholders.
  • Excels at people management; builds exemplary teams and achieves results through effective management of resources
  • Strong communication skills both upwards and downwards and outside the company. Ability to lead and communicate orally, written and in formal presentations.
  • Effective project and time management skills and the ability to work under pressure.

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.

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