CQ Lead and RP Surgery UKIreland

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and cured where treatments are smarter and less invasive and solutions are our expertise in Innovative Medicine and Med Tech we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for more at .

As guided by Our Credo Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson we respect the diversity and dignity of our employees and recognize their merit.

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About Surgery

Fuelled by innovation at the intersection of biology and technology were developing the next generation of smarter less invasive more personalized treatments.

Are you passionate about improving and expanding the possibilities of surgery Ready to join a team thats reimagining how we heal Our Surgery team will give you the chance to deliver surgical technologies and solutions to surgeons and healthcare professionals around the world. Your contributions will help effectively treat some of the worlds most prevalent conditions such as obesity cardiovascular disease and cancer.

Patients are waiting.

Your unique talents will help patients on their journey to wellness. Learn more at a CQ Lead and RP Surgery UK/Ireland:

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 Italy UK/IRL France Spain

MSMs cluster (Nordics Benelux Austria Switzerland Portugal Greece Israel)

EMs cluster (Middle East Africa CEE South Africa Turkey Russia/ CIS)

The responsibilities and the impact

YOU will have:

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 ISO
  13485/ISO
  9001/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 MOHs 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…