Beschreibung
Task:Distribution and Inventory Management Processes
- Accountable for overseeing the development / remediation controls and quality standards for all distribution and inventory management activities (e.g. receiving, pick, pack, lot reconciliation), and managing communication on progress within the company.
- Accountable for the quality oversight of all product quality holds and field actions impacting the Distribution Center.
- Responsible for evaluating the company?s quality and distribution process capabilities against company and industry standards and regulatory expectations. Special Processes (Product Testing, Repack-Relabel, Temp. Control & Monitoring)
- Accountable for ensuring requirements for physical product testing (e.g. functional testing, visual inspection & verification) occurring in the DCs.
- Responsible for ensuring implementation of the requirements for repackaging and relabeling operations to be conducted within the Distribution Center.
- Accountable for ensuring appropriate Quality management of repacking, relabeling, over labeling, kitting, and reworking operations conducted within the DC
- Accountable for ensuring adherence to temperature control and monitoring requirements within the facilities.
- Accountable for ensuring validation of temperature controlled (cold chain and controlled ambient) facilities with support and directions from the Sr. Manager Temperature Control Q&C, CLS Q&C EMEA.
- Accountable for ensuring accurate and timely communication of temperature control excursions occurring within the DC to appropriate partner.
- Accountable for ensuring appropriate investigation of temperature control excursions and subsequent remediation activities
Quality Management Systems
- Responsible for ensuring the appropriate handling of distribution related customer complaints including track and trend and mitigation of Quality related issues.
- Responsible for overseeing the controls and quality standards for Quality systems validation, including WMS, CAPA, NC, Internal Audits, Doc mgmt software systems
- Accountable for ensuring management of Quality systems, including CAPA process and systems, document management, change control, training management, preventative maintenance systems, other.
Compliance
- Responsible for ensuring management of Management Reviews of the DCs.
- Accountable for the successful management of all Health Authority inspections (e.g., FDA, BfArM (BOPST), etc.) conducted.
- Responsible for the proactive identification and mitigation of compliance risk at the DCs through internal audits.
- Responsible and accountable for the management of facility licenses.
- Support the department appropriate goals and objectives, and business measurements
Requirements (Must have):
- Change management and project management experience.
- DC Q&C management.
- Understanding the linkages in quality and regulatory compliance in delivery to customer and health authority.
- Compliance experience, QMS experience.
- Strong presentation skills.
- Issue remediation experience.
- Collaborative approach.
- Managing complexity.
- Analytical skills with a Bifocal approach - ability to zoom-in/zoom-out for tactical, high-level and detailed, etc.
- Previous experience interfacing with global regulatory agencies, e.g., FDA, BfArM, etc, and a history of success and credibility resolving complex regulatory compliance issues.
- Fluent in German & English
Environment/Miscellaneous:
Location is within the DACH cluster in Neuss with requirement of 50% travel within Germany.
Beginn: 15.10.2013
Dauer: 28.02.2015
Branche: Medizin/Healthcare