Executive Director

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 international bodies.
- Ensure end to end compliance cycle SOP-Training
- Metrics/Trending
- Lessons learned to drive meaningful customer experience across the enterprise.

**Oversight**:

- Provide strategic direction pertinent to the Systems, Processes, Procedures for internal QA team (global/ local), but also to:

- Global Medical Affairs
- Global Project Teams
- Clinical Safety and Pharmacovigilance
- Global R&D/ Clinical Development/ Clinical Operations
- Vendors/ CROs
- Establish a globally deployed QMS standardization and process improvements to areas of responsibility to include but not limited to:

- CAPA
- Management Review
- QEs/Non-conformances
- Quality Systems Review, Quality Planning, and Quality Objectives
- Data and Document Management
- Records Management
- Training Management
- Lead/ Establish the creation, review of all relevant Quality Manual documents (R&D & PV QA specific). Ensure stakeholder management for adapting such standards, policies across R&D, CSPV and MA.
- Establish key governance and lead the oversight of the overall Quality Management System for areas of oversight.
- Define specific QMS needs and QMS strategy along with R&D, CSPV, MA, GQA management and R&D & PV QA LT]
- Ensure a functional quality team is in place responsible to establish cross functional review process along with SMEs (i.e., SOPs, SOIs) for up-to-date reviews o