For our headquarters in Munich we are seeking highly qualified candidates to fill the position:

Senior Manager (m/f/x) PV Quality Management

The Position:

This position is responsible for the quality management of PV tasks fulfilled by DSE (EU   headquarter office), EU affiliates, CROs and license partners and proactively monitors quality of all PV tasks (including compliance monitoring) and ensures operational standards are well-maintained and continuously improved.

This position is also expected to contribute and lead global projects and tasks together with the global Quality Management Team to enhance Daiichi Sankyo Global PV Quality Management System by implementing further globally harmonized standards and validated tools for process improvement, automation and trend analysis.

The focus of the role is specifically in the QMS area of the management of non-conformances to DS procedures, and Corrective and Preventative Actions (CAPA) arising from Quality Events (as escalated to PV Quality Assurance), audits and inspections.

Roles and Responsibilities:

• Bring ideas for potential process improvement and global harmonization based on industry standards and industry benchmarking
• Organize “lessons learned” and implement systems and tools for process improvement and enhancement
• Support the preparation for internal audits and inspections, including identifying and updating SME lists, coordinating pre-audit/inspection document requests, logistical planning for the audit/inspection, in collaboration with QA, as applicable
• Define, manage, maintain and coordinate processes and related procedures to continuously improve quality and inspection readiness in collaboration with the CSPV group (e.g. audits, inspections, key performance indicators, deviations (non-conformances) and CAPA management, SOP revisions)
• Lead CAPA plan development for inspections/audits and quality events in collaboration with QA functions and other SMEs
• Facilitate inspections/audits in collaboration with QA function (e.g. preparation meetings, coordination of document requests and lessons learned)
• Gather and collate global data for assigned KPIs to share with senior leadership
• Implement systems/tools for process improvement/enhancement
• Control Tasks
• Proactively monitor quality of PV tasks in scope, facilitate appropriate actions with SMEs and achieve continuous improvement
• Track CAPA implementation status regarding non-conformances, findings of inspections/audits and quality events
• Collate summary information on DSE CAPA status to present to EU/UK QPPV and DSE Regional Head
• Leading the CSPV department regarding PV inspection/audit preparation and CAPA plan development including but not limited to:

• • Lead/organise appropriate processes according to industry standards for improving and keeping the regional and global organization inspection ready
  • Manage projects with subject matter experts to enhance inspection readiness
  • Identify and implement strategies for process improvements and harmonisation
  • Act as the DSE PVQM and/or Global main point of contact for all audit and inspection related matters
  • Supervise junior staff members (including contract staff) as needed

Personal Skills and Professional Experience:

• Master’s degree in Life Sciences, Pharmacy or Medical Sciences preferred and solid experience in GxP and in PV
• Experience in the field of audits, inspections, quality management and CAPAs in the GVP area
• Good knowledge of European PV legislation
• Highly reliable with accurate operating principles
• Analytic and systematic approach with good problem-solving skills
• Ability to understand complex matters with a continuous focus on improvement
• Substantial communication skills, in particular on an intercultural level with respect and appreciation of cultural diversity
• Proactive and autonomous working style
• Demonstrates effectiveness in working with different functions and partners in a multi-disciplinary and matrixed environment
• Fluent oral and written communication skills in English