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 of such GxP documents, its robustness and fit for purpose.

Leadership/ team management

• Create a high performing team environment and a cohesive culture driven by values of integrity, respect, and culture of speak up
• Create an environment that fosters diversity of thoughts, inclusivity and one that adheres to the principals set forth in the organization (JOIN, GROW, THRIVE)
• Create an environment that thrives on innovation, proactive quality and is disciplined to efficiently execute against pre-defined deliverables.
• Lead remediations and risk management to assure the organization’s quality management system is robust and ensure knowledge transfer and continuous process improvement in collaboration with other QA functions.

External Engagement

• Contribute, help shape the associated external regulatory environment through participation in industry-wide organizations to assure the needs of the company are proactively established and that innovative approach to solutions are in place.
• Continuously review compliance metrics trends from regulators/ industry experts and develop the QMS road map to meet changing regulatory and business needs.
• Drive effective relationship with alliance partners, collaborators, vendors, and other key company partners to ensure a culture of compliance at all levels

Strategy

• Shape the strategic direction of the global Management System based on the organization’s mid-term plan and beyond.
• Ensure adequate resources are in place and create a strategy for global QMS across regions and geographic areas.
• Effectively manage budget.
• Create and maintain the strategic road map, metrics, dashboard, and project management methodologies to lead an efficient and effective organization.

Personal Skills and Professional Experience:

• Bachelor's Degree in a scientific discipline required, Master's Degree or other advanced degree is preferred
• Extensive previous experience at a senior management level leading a QMS organization with a strong focus in the GCP/ ICH/ GvP area and demonstrated track record of successful results, or equivalent experience
• Significant experience in managing many aspects of quality in an international, global context in a regulated health care environment.
• Profound experience in Pharmaceuticals, Oncology, Vaccines, Diagnostics, Consumer Healthcare products,
• Strong expertise in risk management, process improvement, process engineering, continuous improvement, change management, and evolving the capabilities of an organization.
• Proven track record in leading direct reports (FTE), temporary workers, and other matrixed team members along with the ability to influence stakeholder collaboration.
• Must have strong interpersonal and organization skills.
• Must have strong leadership skills
• Must have a strategic mindset, ability to analyze trends and risks and communicate clearly in an international multi-cultural organization. Must be a decisive leader with a clear vison and strategy and ability to execute such strategy through team and/ or directly.
• Seasoned experience working directly with global Health Authorities (FDA, EMA, MHRA) and other government and local agencies
• Demonstrated knowledge of the end-to-end Drug development process (manufacturing to commercialization).
• Must have the ability to travel (25%) domestic and international.