Executive Director (m/f/x), Quality Management System R&D & PV QA

 

Passion for Innovation. Compassion for Patients.

 

With over 120 years of experience and approximately 19,000 employees in more than 30 countries/regions, Daiichi Sankyo is dedicated to discovering, developing, and delivering new standards of care that enrich the quality of life around the world.

In Europe, we focus on two areas: The goal of our Specialty Business is to protect people from cardiovascular disease, the leading cause of death in Europe, and help patients who suffer from it to enjoy every precious moment of life.

In Oncology, we are driving innovation in solid tumours and blood cancers, founded on breakthrough science from our own labs in Japan. We aspire to create better tomorrows for people living with cancer and their loved ones.

Our European headquarters are in Munich, Germany, and we have affiliates in 15 European countries and Canada.

 

 

 

For our Daiichi Sankyo European Headquarters (in Munich), we are looking for a

 

Executive Director (m/f/x), Quality Management System R&D & PV QA

The Position:

The Executive Director, Quality Management System R&D & PV QA reports to the Vice President of Quality Assurance, Global R&D & PV QA, and oversees multiple levels of direct reports (Sr Director, Director, Associate Director, Senior Managers, Contractors etc.,) across the global QMS function located in EU, JP/APAC and Americas. This individual is a member of the global quality assurance R&D & PV  QA leadership team and an extended member of Global Quality Assurance Leadership Team (GQALT). The position may also represent R&D & PV QA in other cross-functional leadership teams such as Dx IT council, Development Leadership Team (DLT), Corporate Compliance and other governance teams, as necessary.

 

This position is accountable to drive harmonization and standardization of the Quality Management System (QMS) in Global R&D, CSPV and Medical Affairs, including SOP and Training processes. Interface and collaborate with all levels of the organizations, including GMP QA, Global QMS and QA teams across regions and countries. Maintain knowledge with current industry trends, Health Authority expectations and influence standards accordingly to incorporate into business processes.

 

Introduce continuous improvement programs to ensure that existing tools, systems and operating processes and procedures supports operational excellence within QA and / or with stakeholders as necessary. The incumbent will be responsible for refining QMS strategy through partnership with internal and external stakeholders.

 

The incumbent will refine and develop a structured SOP review and approval process (end to end) within the quality organization framework. Assess existing governance and introduce changes wherever necessary. A transformational leader with strong experience in the GCP,GLP/GCLP, GVP area and working knowledge of GMP/GDP requirements.

 

The role will manage global R&D & PV QA QMS resources in an efficient and effective manner including, but not limited to oversight of defined work products, coaching and mentoring of global teams, performance management and contributing to organizational efficiencies.

Roles and Responsibilities:

• Proactively ensure that all functions consistently operate in a state of compliance.
• Establish the Quality Planning and Quality Objective process ensuring an effective monitoring and escalation process along with establishing programs to effectively monitor and assess the global quality system through metrics and scorecards.
• Define the process for alignment and collaboration of QMS related activities with other functions whenever needed.
• Develop the strategic direction for quality and compliance training needs for areas of oversight.
• Ensure an effective governance structure is in place to proactively react to and define QMS expectations and associated standardization for area of oversight across the organization.
• Lead/ establish a harmonized/ standardized processes within cross functions through key established governance (i.e., GSOP committee, QMS Steering Committee) to avoid conflict of procedures and processes within the functions.
• Lead/ Collaborate and partner with stakeholders including other quality teams on critical initiatives and transformations.
• Act as management representative for all key health authority inspections (US FDA, EU EMEA, MHRA etc.), specifically where QMS is in question. Develop and maintain an effective working relationship with US FDA and other