Associate Director, Quality Lead Germany
Vor 2 Tagen
At Bristol Myers Squibb, we are inspired by a single vision - transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.
**Key Responsibilities and Major Duties**:
- Lead and manage the Quality Team in BMS Germany
- Ensure that a Quality Management System is implemented and maintained in BMS Germany, including:
- Acts as the local Responsible Person responsible for GDP in accordance with - 52a AMG, AMWHV and Arzneimittelhandelsverordnung
- Maintains Quality System Documentation like
- BMS Policy/Directives/SOPs including impact assessments and implementation
- GDP and Local regulations including impact assessments and implementation
- Ensures implementation of Quality Operations, for example:
- Suppliers management oversight: Quality Agreements, approving the local subcontracted distribution activities, evaluate and confirm the overview of the distribution supplier qualification status
- Customers oversight: periodic customer License verification
- Product Quality status and oversight of the approval to the market process
- Management of compliance/quality incidents
- Facilitate that BMS requirements are implemented in the Local/Regional Distribution Centre
- Manage the Quality Risk Management
- Host Inspections and perform Regulatory Surveillance
**Requirements**:
- Master’s degree in Pharmaceutical Sciences and “Approbation als Apotheker”.
- 10 years of progressive experience within the quality function of the pharmaceutical industry.
- Proficient in cGMPs, cGDPs, local pharmaceutical regulations and regulations promulgated by EMA or German Agencies.
- Ensures the compliance with authorized distribution channels according to section 47 of the German Drug Act (AMG).
- Deals with complex issues using critical analysis and develops of ethical, reasoned solutions to meet both business and regulatory requirements.
- Impacts and influences the organization by communicating quality issues and decisions, which impact the business.
- Ensures compliance of market Third Party Distribution partners to BMS Quality requirements related to distribution and transportation.
- Ensures continuous improvement activities for a more effective Quality systems across the organization.
- Fluent in German; good verbal, written and presentation skills in English.
- Innovative, creative and able to utilize available resources.
- Demonstrated ability to switch priorities and manage more than one project at the time within a multi-disciplinary environment.
- Demonstrated ability to influence, collaborate and communicate directly and to work in cross functional and cross regional teams.
- Strong negotiating skills for interfacing with Health Authorities and market business functions.
**#LI-Hybrid**
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.
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