Daiichi Sankyo Europe GmbH

Quality Control Manager (m/f/x) for Pharmacovigilance

München
Feste Anstellung
Vollzeit

Passion for Innovation. Compassion for Patients.™

Daiichi Sankyo and its 15.000 employees in more than 20 countries are dedicated to the creation and supply of innovative pharmaceutical products. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group’s 2025 vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology. Our European headquarters are in Munich, Germany and we have affiliates in 13 European countries including Denmark, where Copenhagen acts as the Nordic headquarter.

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

Quality Control Manager (m/f/x) for Pharmacovigilance

Purpose of the function:

The Quality Control Manager will work with Quality & Compliance Lead to maintain and enhance Daiichi Sankyo PV Quality Management System in collaboration with other regional teams in the US and Japan and maintains Pharmacovigilance System Master File (PSMF). This position is responsible for the quality control 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.
This position is also expected to contribute to the global projects together with Quality & Compliance Lead 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.

Role and Responsibilities:

Maintenance of Pharmacovigilance System Master File (PSMF) and related documents
Define, manage, maintain and coordinate procedures continuously improving quality in collaboration with the CSPV group (e.g. compliance check expedited reporting, key performance indicators, deviations and CAPA management, revising SOPs)
Proactively monitor quality of PV tasks, facilitate appropriate actions with SMEs and achieve continuous improvement
Leading the CSPV department regarding PV Inspection/audit preparation and CAPA plan development and tracking CAPA status regarding deviations and findings of inspections/audits
Lead and organize preparation meeting, coordinates requested document preparation with SMEs
Lead CAPA plan development and its status tracking and facilitate inspections/audits in collaboration with QA functions
Bring ideas for potential process improvement and global harmonization based on industry standards and industry benchmarking
Organize “lesson learned” and implement systems and tools for process improvement and enhancement

Personal skills and professional experience:

Master’s degree in Life Sciences, Pharmacy or Medical Sciences preferred and 5-8 years of experience in GxP and in PV
Experience in the field of safety data processing or clinical development and in contract management
Excellent computer, presentation and communication skills – very good verbally and written English
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 also on intercultural level with respect and appreciation of cultural diversity
Proactive, autonomous and reliable working style paired with the ability to work in international matrix teams

What we offer:

We offer an interesting, diversified and challenging position, good contractual conditions, flexible working models, all the social benefits of a modern company and a professional environment where you will have the opportunity for personal growth.