Qualitatsmanagement à Allemagne

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With over 120 years of experience and approximately 19,000 employees in more than 30 countries/regions, 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 are driving innovation in solid tumours and blood cancers, founded on breakthrough science from our own labs in Japan. We aspire to create better tomorrows for people living with cancer and their loved ones.

Our European headquarters are in Munich, Germany, and we have affiliates in 15 European countries and Canada.

We are seeking a highly qualified candidate to fill the position:

Senior Director, PV Quality Management Lead (m/f/x) Europe

The Position:

This position is responsible for all aspects of DSE PV Quality System Management including compliance and performance monitoring through the implementation of consistent global metrics and KPIs (e.g. PV operational and medical safety/risk management, CAPA management, procedural document and records management, audit/inspection readiness, and training programs), in alignment with Global PV strategy. This position may also be assigned responsibility for leadership of key aspects of the PV Quality Management System at the Global level. This position will have line management responsibility for the DSE PVQM team. In addition, this position may include matrix management across regions for global initiatives.
This position leads the development and ensures conduct of an integrated quality management system for PV processes, leads and develops strategy for the PV Quality Management (PVQM) function at the Regional and Global level, as applicable and ensures its consistent execution across projects. The position reports into the Executive Director PV Systems and Operations for DSE and the Global Sub-Function Lead for PVQM.

Roles and Responsibilities:

• Manages and drives the development of an integrated and systematic concept/approach to quality management across key PV business processes. Will lead the definition of relevant performance parameters for PV activities in cooperation with other PV sub-functional leads. Manages a team that is responsible for issue and CAPA management for all PV processes to ensure internal processes are evaluated, summarized, and fed back for implementation of actions and process improvement. This position will also organize appropriate quality measures for outsourced activities.
• Leads the development and implementation of meaningful and consistent global metrics and a KPI monitoring system across PV processes to ensure compliance and alignment with regulatory expectations, current risks, and priorities of the CSPV department. Drives appropriate communication and escalation of safety compliance-related issues within CSPV including leadership/QPPV, and other relevant stakeholders for continuous improvement. Identify and develop process improvement initiatives to meet business objectives, ensure continued compliance, and achieve optimal efficiency.
• This position is responsible, with its direct reports, to develop and maintain an effective system to support conduct of inspections and audits, closely collaborating with the Global GxP/PV QA audit department in preparation for regulatory inspections. This role will be the primary contact partner for the QA audit department, will analyze audit and inspection findings and suggest remediation as well as maintain an overview of responses (pending and final) and resulting measures.
• This position is responsible for overseeing the PV document management system including maintenance of working documents and procedures such as global SOPs/SOIs.
• Oversees the development and management of an ongoing onboarding and training programme for DSE CSPV with global alignment. This position drives the maintenance of the training curricula and development of materials, timelines, delivery mechanisms, and record keeping. Engages with global sub-function leads to understand the needs of each sub-function/role and ensure the appropriate trainings are part of each global role-based curriculum.
• Aligns the strategy for the Global Core PSMF, within PVQM and across CSPV sub-functions (including the affiliates). Ensures a robust process for Global Core PSMF (body and annex content) generation and rollout across CSPV with timely provision of the document in accordance with internal scheduling and regulatory requirements.

Personal skills and Professional Experience:

• A minimum of Bachelor’s degree preferably in healthcare or life sciences required; Medical Doctor, Masters Degree, Pharmacist.
• Sufficient expertise in local, European and international regulatory and pharmacovigilance requirements.
• Work experience in pharmacovigilance of at least 12 years, experience, including both investigational and marketed products, and comprising at least 7 years management experience.
• Reads, writes and speaks English fluently.
• Develops quality expectations and supervises others within the function; actively develops and implements changes to improve quality within the function.
• Experienced in situational leadership, possessing the ability and interest to develop and grow individuals in the team as well as the team as a whole to enhance motivation and productivity.
• Develops and executes complex functional strategic plan; effectively prioritizes tasks in accordance with strategy and provides guidance to others within the regional and/or global functions (as applicable).
• Possesses an expert ability to independently identify issues and thoroughly understands the causes of those issues; recognizes the functional impact; can balance risks; provides suggestions for resolution and implements the solution.
• Provides leadership and serves as a subject matter expert throughout the function; possesses an expert knowledge and experience to influence PV processes to multiple complex programs.
• Communicates effectively within the project team, cross-functionally regionally and globally; builds and maintains strong business relationships across project teams and functions regionally and globally, by building trust, credibility, and support.
• Ensures team consistently executes internal and external deliverables on time; consistently manages functional activities in response to changing conditions.
• Leverages pharmacovigilance knowledge to promote efficiency /effectiveness and compliance for assigned projects within the function and externally as applicable; shares expertise within function.