Beschreibung
Aufgaben:The Senior QA Associate Cluster Quality [&] Compliance, Customer [&] Logistics Services / Market Quality [&] Compliance EMEA reports solid line to the Manager DACH Cluster Distribution Quality [&] Compliance EMEA. The position serves as a single point of contact between the partner facility and the corresponding CLS cluster operational and Quality leads on Distribution Quality related matters (e.g. NC/CAPA, Customer Complaints)
Start: ASAP
Dauer: 8 Monate
Ort: Düsseldorf / Frankfurt
Qualifikationen:
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 - 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
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
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
Experience and key competencies:
- This
role requires a diverse business background, with specific quality,
regulatory and regulatory compliance competencies in the areas of:
customer service, distribution and commercial customer interface. A
minimum of 5 years of experience in positions of increasing responsibility, with broadly based quality management experience - Experience with the global demands of the role specifically: healthcare regulatory requirements
Proven success in:
- Change management and project management experiencet
- Understanding the linkages in quality and regulatory compliance in delivery to customer and health authority
- 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