Director/ Lead Commercial Quality

**Job Function**:
Quality
**Job Sub Function**:
Customer/Commercial Quality
**Job Category**:
People Leader
**All Job Posting Locations**:
Hamburg, Germany, Norderstedt, Schleswig-Holstein, Germany

**Interne Ausschreibung: 15.04.29.04.2025**:
**NON-Tarif**

**Director/ Lead Commercial Quality & Compliance MedTech**:
Under the general direction of the Senior Director Commercial Quality, this position is responsible for establishing and leading Johnson & Johnson overall quality management framework and quality system for the country/cluster, establishing preventive and corrective actions to mitigate potential or actual non-compliance risks and ensuring compliance to attain world-class operational/customer focused capabilities.

The overall management responsibilities also require exerting leadership in regional projects and initiatives providing strategic direction to achieve established goals. Role complexity includes but is not limited to ability to interact cross segment and representation of the region in global projects and initiatives.

The country/cluster lead is responsible to lead activities towards the integration of the quality management systems for applicable country(ies). This position is responsible for ensuring the QMS requirements are effectively executed in the markets in accordance with local regulations, corporate and segment policies and procedures.

The scope of this role is applicable to the Commercial Quality operating in Germany, UK/IRL, J&J Managed Services (UK) France, Italy, Spain, Russia/ CIS, MSMs cluster (Nordics, Benelux, Austria, Switzerland, Portugal, Greece, Israel),CEESAT cluster (CEE, South Africa, Turkey), MEA cluster (Middle East, Africa)

**Key responsibilities**:
**Manage Quality Systems**
- Lead the Cluster/Country Commercial Quality organization, including handling, storage, distribution, Level 2 (in-country) customer Service, Technical Service and Repair, and commercial activities, to ensure a proactive approach to quality assurance and quality systems.
- Act as Quality Management Representative as per ISO13485/ISO90001/QMS definition, as applicable.
- Develop appropriate strategic and process performance measures/targets such as delivery service issue management.
- Manage the overall corrective and preventive action (CAPA) and risk management processes.
- Establish and maintain global and local relationships with partnering organizations and regulatory bodies.
- Oversee the management of Standard Operating Procedures, ensuring simplicity, standardization, and education across the cluster/country.
- Operate as a key business partner for quality and process improvement, understand business requirements.
- Ensure compliance to all applicable quality standards and regulatory requirements
- Ensure troubleshooting and solutions to quality issues through statistical analysis and process excellence tools.
- Ensures timely escalation of Quality or Regulatory Compliance Issues
- Ensures compliant and timely Field Action execution
- Present case studies and metrics to Cluster/Country Leadership.
- Coordinate/guide execution of internal audit, and external party audit as needed.
- Lead/guide the management review process for the Cluster/Country. Propose initiatives for quality performance improvement.
- Drive complaint vigilance execution in the countries, where applicable, ensuring the timely closure of product related complaints cases, quality, and immediate escalation.
- Understand current requirements of Regulatory Agencies such as local MOH’s, as well as, of standard organizations such as ISO.
- Ensure compliance with the J&J policies and local regulations at LOC, the local warehouses and distributors, including external partners. Liaising with other functional areas as appropriate in the execution of these tasks.
- Establish proper surveillance of the distribution activities (cold chain and loaner kits)
- Effectively work with Cross Segment leadership (functional and commercial) in the deployment and sustainability of initiatives that will support QMS execution and compliance on designated countries.
- Management of Pharmacovigilance and Post Market Surveillance systems within the country/cluster in compliance to local regulations
- Ensure compliance with Distributor and Importer roles as EU MDR Economic Operator (where applicable)

**Strategy and Planning**:

- Develop a common vision and strategy for Quality and Process Improvement
- Entrench a process improvement culture within the business. Implement process management practices, verify/validate project results and advocate further use of Process Excellence to drive business results.
- Embed QMS management principles in the organization, creating cross-functional process improvement teams who effectively complete improvement projects central to these efforts.
- Engage all company employees in these initiatives, through interactive project coaching/consulting and change management strategies
- Develop appropriate str