Director, SC Quality Jabil Collaboration.

Job content

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Director, SC Quality Jabil Collaboration

Location: Zuchwil, Switzerland

The Director, Supply Chain Quality Jabil Collaboration serves as the Johnson & Johnson Medical Devices (JJMD) leader overseeing quality activities at the Strategic Collaborator (SC) manufacturing sites located in Switzerland (Bettlach, Grenchen, Balsthal, Hagendorf, Mezzovico, Raron, and Le Locle) and Germany (Umkirch and Tuttlingen). He/she ensures that appropriate communication channels are established and maintained between JJMD and the Strategic Collaborator. This position oversees site activities with potential impact to JJMD product quality and quality management system. He/she is accountable for ensuring that the Strategic Collaborator has a clear understanding and ability to execute against the requirements of JJMD’s Quality System and the Quality Agreement. He/she is responsible for the in-scope sites to develop and support initiatives and responses to internal quality related matters. He/she also assesses the Quality System through input into the Management Review and Joint Quality Reviews at the Strategic Collaborator and JJMD levels.

This position is located at the Synthes, GmbH, Headquarters in Zuchwil, Switzerland. The Director of Quality Jabil Collaboration represents the SC quality function on the PaM (Principal as Manufacturer) Leadership Team for all in-scope sites under Synthes GmbH. He/she is responsible for overseeing the quality performance of the Strategic Collaborator.

• Oversees quality activities at the Strategic Collaborator (SC) manufacturing sites located in North America (Monument, Elmira, Brandywine and Wilson Drive), Switzerland (Bettlach, Grenchen, Balsthal, Hagendorf, Mezzovico, Raron, and Le Locle) and Germany (Umkirch and Tuttlingen).
• Oversees site activities with potential impact to JJMD product quality and quality management system. The Director of Quality Jabil Collaboration is accountable for ensuring that the Strategic Collaborator has a clear understanding and ability to execute against the requirements of JJMD’s Quality System and the Quality Agreement. Identifies Quality Agreement changes, as required.
• Responsible for developing and implementing key strategies and continuous improvement initiatives in support of the oversight model between the SC and JJMD.
• Responsible for managing oversight activities, including Quality Management, Quality Engineering, and Product Release Monitoring at each of the in-scope SC manufacturing locations.
• Collaborates with SC on escalation decisions as per Quality Agreement and J&J Escalation Standard.
• Approves Corrective & Preventive Action Plans (CAPA) as per requirements of the Quality Agreement and the Quality Systems Execution Plan (QSEP)
• Provides External audit support for JJMD products and/or quality systems and partnerships with SC and JJMD Regulatory Compliance in the development of responses to regulatory bodies as it relates JJMD products and/or QS observations.
• Reviews site monthly dashboard and partners with SC establishing improvement plans to address below target metrics and negative trends.
• Leads Joint Quality Review process for in-scope sites.
• Tracks on-time completion of actions resulting from the review. Provides adequate resources to support the requirements of the JQR process. Ensures effectiveness of the JQR process and identifies improvement opportunities. Identifies Topics or Quality issues that need Elevation and possible Escalation from the JQR to JJMD Senior Management Reviews.
  
  

Qualifications

• Bachelor or Masters Degree in Quality, Regulatory, Business, Engineering, Science or other related field
• 10+ years experience in a Supply Chain, Commercial and/or R&D function
• 5+ years experience in people management
• Experience in Medical Devices is high preferred.
• Experience with Six Sigma/Process Excellence tools, training and certification is preferred.
• Experience with ideation events and/or in innovation methodologies (ex = Design Thinking, Agile, Lean)
• Strong influencing skills with ability to see issues from multiple viewpoints and understand differing needs of stakeholders
• Executive presentation & facilitation skills with the ability to drive decisions and influence multiple stakeholders and partners
• Strong understanding of Purchasing Controls and innovative applications for various risk management and risk mitigation tools
• Proven ability to identify and manage risk, including escalation, prioritization and resolution of Quality issues.
• Demonstrated strong communication (verbal, written and visual) and networking ability at a global level to execute with cross-functional stakeholders/partners and ability to influence without authority.
• Strong business acumen, including demonstrated experience in identifying and leveraging analytics and data for business problem solving
• Demonstrated ability to lead through change and serve as a change agent
• Must be able to translate project/technical outcomes into execution and appropriate reporting, dashboard/scorecard formats
• In-depth knowledge of quality and manufacturing systems and processes and applicable regulations, i.e. ISO 13485, FDA’s GMPs for medical devices
• This role includes regular domestic and international travel. (<25%)
  
  

For more than 130 years, diversity, equity & inclusion have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo. We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences. That is why we are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued, and each and every one of our people feels that they belong and can reach their potential. No matter who they are.

Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”!

Primary Location

Switzerland-Solothurn-Zuchwil-

Organization

Synthes GmbH (7111)

Job Function

Quality

Requisition ID

2206011387W