Director, Global QA Strategy & Operations

Daiichi Sankyo US•Basking Ridge, NJ

16d

About The Position

Director, Global QA Strategy &Operations (Global R&D PV QA) is responsible for providing strategic leadership for QA initiatives across the organization. This role involves collaborating closely with the Head, Global R&D PV QA and the Head of Global QA Strategy and Operations to ensure alignment and execution of global initiatives. The incumbent will oversee the development and promotion of the 6th Mid-Term Strategy for Global QA, lead the execution of the business plan, and manage resources effectively to meet Global R&D PV QA / Global QA goals. This role requires a deep understanding of the complexities of a global organization, with significant latitude for decision-making and problem-solving. Establish and / or develop operational resource strategy to successfully deliver strategic business change and objectives of QA.

Requirements

Bachelor's Degree Bachelor's degree in Life Sciences, Pharmacy or Medicines required
10 or more of professional experience in the pharmaceutical industry, with a focus on project management and operational support. required
In-depth knowledge of Health Authority expectations and experience in a GxP regulated environment is essential.
Strong interpersonal, communication, negotiation, and problem-solving skills.
Experience working cross-functionally and in global teams, with an understanding of organizational dynamics.
Must possess strong leadership, interpersonal, communication, negotiation and problem-solving skills.
Must have ability to work independently and in a team environment.
Demonstrated experience and proven track record of successfully leading projects with high impact.
Ability to effectively interact with and present to senior management at all levels, as well as to external audiences and inspectors.
Must have the ability to travel up to 20% both domestic and international.

Nice To Haves

Master's Degree preferred
PhD preferred
Considerable organization awareness (e.g., interrelationship of departments, business priorities), including significant experience working cross- functionally and in global teams.
Strong Industry Network in clinical development.
Knowledge and understanding of cultural differences and diversity issues.
Strong written and oral communication skills (English).

Responsibilities

Strategic Leadership and Engagement: Serve as a member of the Global RD PV QA Leadership team, developing standard approaches that foster a reputation for outstanding quality, collaboration, rigor, and follow-through.
Collaborate with the Head Global RD PV QA and the Head Global QA Strategy Operations to identify and Global RD PV QA Leadership Team members and build capabilities required for the future team, while developing talent through mentoring and high expectations.
Develop, Execution and Management of Global R＆D PV QA Mid-Term Strategy and Business Plans: Develop and Oversee the execution of the Mid-Term Strategy for Global RD PV QA, ensuring objectives are met effectively.
Develop methodologies that enable the team to respond to requests and implement a balanced scorecard to monitor productivity and efficiency.
Develop a standard approach for monthly Global QA reports based on Business Plans.
Cross-Functional Leadership and Communication: Act as a trusted leader, directing QA Strategy and Operations team members.
Develop and manage presentations and communications for key leadership meetings, and lead change initiatives by deploying operational excellence methodologies across teams.
Lead global recruitment efforts to attract and retain top talent within the organization.
Foster the growth and development of team members to enhance overall performance and engagement.
Operational Strategy Implementation: Cascade and disseminate operational strategies necessary for implementation within respective QA functions.
Gather and communicate up-to-date feedback from line function heads for effective decision-making, and present to the Global Head of RD, PV QA/Vice President of Quality.
Facilitating leadership meetings as needed and ensure timely delivery of presentations and documentation.
Accurate and state of the art presentation skills, power point, Visio, budget, resources, algorithms, projections, risk management and mitigation.
Operational Oversight and Reporting: Oversee the management of QA shared resources, ensuring accuracy and timely updates of information related to ongoing activities.
Produce and deliver accurate reports and documentation related to Global QA activities in collaboration with relevant stakeholders.