Biologist - Quality Management, Director (m/f/d) (Biologe/Biologin)

Stellenangebotsbeschreibung:

Passion for Innovation. Compassion for Patients.

With over 120 years of experience and more than 17,000 employees in over 20 countries, 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 strive to become a global pharma innovator with competitive advantage, creating novel therapies for people with cancer.

Our European headquarters are in Munich, Germany, and we have affiliates in 13 European countries and Canada.

We are seeking highly qualified candidates to fill the position:

Director R&D Quality (m/f/x)

The Position:

Lead the implementation of the quality strategy closely aligned with the business strategy within one or more Global Project Team(s) (GPT) within Oncology Development Franchises or Business Units.

Provide strategic and proactive QA Leadership for respective GPTs, R&D Clinical Programs and Post marketing studies or Post approval commitments in close alignment with the Head of R&D QA. Within assigned GPTs, facilitate the implementation of a risk-based quality management process fully embedded through trial design, execution and submission including all vendor managed business setups with the objective of achieving the highest data quality standards, full adherence to patient's rights and well-being and in support of successful Health Authority inspections and approvals.

Lead in a proactive and strategic way and through collaboration with other GxP Quality representatives, act as QA point person for all GxP matters for the Global Program Head and the Global Program Team.

Provide operational QA leadership for the respective GPTs, including Quality Oversight for the Quality Plan execution, Health Authority Commitments, Critical Incidents including, respective escalation and the CAPA Management Process for the respective business areas.

Facilitate the implementation of the quality strategy in close alignment with the GPT business strategy. Monitor and track implementation and break-down of the Quality Manual into an annual Quality Plan together with the supported GPTs including the quality risk assessments and inspection readiness components for the designated programs. Ensure proactive representation of Quality professionals at strategic project team and at GCP strategic discussions.

Support the Head of R&D QA with Quality Reviews of respective product profile to ensure appropriate management review of all quality and compliance related topics including the review of Key Quality Indicators (KQIs). Identify appropriate continuous improvement initiatives for quality and compliance related areas. Deputize for the Head of R&D QA at the Development Leadership teams, as appropriate and as needed.

Interact with senior Oncology Business Unit and Functional Units leadership teams to ensure Quality is consistently and proactively represented at program level and along the clinical trial process in support of a proactive quality risk management process. Interact with the audit function, the respective Data Management groups and respective CROs in order to ensure high data quality and proactive detection and resolution of issues.

Lead effective communications within the GPT, by interacting with other GxP QA functions (GMP/ IMP QA, Audit and Compliance, Quality Management System (QMS) QA and PV / MA Quality) and in close collaboration with CAPA Manager), on GxP topics/Issues impacting the respective clinical programs.

Help to Ensure, in collaboration with CDO (Clinical Development Operations) or other business process owners, that applicable clinical development processes and quality standards which are in line with worldwide HA requirements are implemented. Help to establ...