Director, Supplier & External Manufacturing Quality-00000R26
Description
LifeScan is a division of Cilag GmbH International; both companies belong to Johnson & Johnson family of companies. LifeScan is engaged in the manufacturing, global distribution and marketing of blood glucose monitoring systems for diabetic patients with markets spanning across Europe, Middle East and Africa, Canada, USA, Asia Pacific and Latin America to create a world without limits for people with diabetes. In order to meet market needs, LifeScan has centralized its logistics structures, distribution and finance processes.
For our offices in Zug Switzerland, we are looking for a
Director, Supplier & External Manufacturing Quality
Job Scope
To direct activities associated with supplier and external manufacturing quality and compliance for the Diabetes Care Franchise (DCF) and Global External Operations (GEO).
- DCF includes External Manufacturers, raw materials, components /packaging material suppliers, test laboratories, and licensing partners for Lifescan, Animas, and Calibra.
- DCF sites are located in Pennsylvania, Puerto Rico, Zug, and Scotland.
- GEO includes External Manufacturers across multiple MD&D franchises including Ethicon, Sedasys, ASP, Animas, and Cordis.
Job Responsibilities
- Establishes strategic supplier relationships to ensure supplier and external manufacturing, packaging and testing support service providers meet quality and compliance objectives.
- Manages the strategy and relationship to ensure that compliant systems and processes are in place from development through commercialization.
- Establishes strategic focus for Supplier and External Manufacturing Quality Engineering initiatives. Provides leadership to define product and process quality objectives and deploy resources to ensure they are achieved.
- Administers regulatory requirements and J&J Policy and Standards to ensure the compliance and business needs are met. Manages these needs to optimize continued growth at supplier and contractor locations.
- Establishes the systemic approach and policies for evaluating and selecting potential suppliers, external manufactures, development partners, acquisitions and alliances.
- Directs and conducts GMP assessments for potential Licensing & Acquisition (L&A) candidates, development partners, and external manufacturers.
- Leads innovative initiatives in supporting the achievement of worldwide business strategies and objectives.
- Lead and support external Regulatory compliance audits of the Zug site for DCF, GEO, and Cilag with regards to Purchasing Controls.
- Develops best in class supplier quality & external manufacturing compliance professionals who provide quality system expertise ensuring that LifeScan products delight our customers by meeting their needs including quality, compliance and supply.
- Act as delegate for the VP of External Operations and Supplier Quality
People Responsibilities
- Recruitment and induction of new staff
- Performance appraisal, people development / training and succession planning
- Team communication
- Performance management
- Developing the culture within teams and departments
- Rewarding performance of staff
- Administration for team members (eg. holidays, sick pay, family and parental leave, expenses, attendance management etc.)
- Termination and transfers of staff
Qualifications
- BS/BA, degree in science, technology, or engineering or equivalent is required. Graduate degree/studies in related discipline / MBA preferred
- Minimum of 10 years of business experience is required. Experience in QRC, R&D, or Supply Chain roles preferred.
- Extensive experience in FDA regulated industry (preferably with both electronic devices and in vitro diagnostics) including experience in the interpretation and application of the medical device GMP regulations is required.
- Demonstrated competency of Risk Management practices, Corrective and Preventative Actions, and regulatory requirements such as FDA QSR’s, ISO 13485:2003 is required.
- Demonstrated ability to work remotely and partner globally is required.
- Ability to lead, negotiate and influence others in a complex matrix organization is required.
- Ability to communicate clearly and concisely across all levels of the company and across the global MD&D supply chain is required.
- Ability to foster an effective multi-functional, cross region, cross company team environment is required.
- Excellent listening, analytical, facilitation and organizational skills are required.
- Strong collaboration, influencing and relationship development skills are required.
- Outstanding presence and communication skills, including the ability to inspire trust and quickly build credibility, are required.
- Strategic thinking ability complemented by hands-on operational and business planning orientation is required. Strong background in Process Excellence, Six Sigma, Lean methodologies or operational excellence is preferred
- Six Sigma GB or BB certification is preferred.
- ASQ Certification is a preferred.
This position will be based in Zug, Switzerland.
Up to 40% EMEA and international travel is required.
BE VITAL in your career. Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
AD CODE: J2W: JOBSCH
Primary Location:Europe/Middle East/Africa-Switzerland-Zug-Zug
Organization: Cilag GmbH International (8525)
Job Function: Quality (Eng)
Description
LifeScan is a division of Cilag GmbH International; both companies belong to Johnson & Johnson family of companies. LifeScan is engaged in the manufacturing, global distribution and marketing of blood glucose monitoring systems for diabetic patients with markets spanning across Europe, Middle East and Africa, Canada, USA, Asia Pacific and Latin America to create a world without limits for people with diabetes. In order to meet market needs, LifeScan has centralized its logistics structures, distribution and finance processes.
For our offices in Zug Switzerland, we are looking for a
Director, Supplier & External Manufacturing Quality
Job Scope
To direct activities associated with supplier and external manufacturing quality and compliance for the Diabetes Care Franchise (DCF) and Global External Operations (GEO).
- DCF includes External Manufacturers, raw materials, components /packaging material suppliers, test laboratories, and licensing partners for Lifescan, Animas, and Calibra.
- DCF sites are located in Pennsylvania, Puerto Rico, Zug, and Scotland.
- GEO includes External Manufacturers across multiple MD&D franchises including Ethicon, Sedasys, ASP, Animas, and Cordis.
Job Responsibilities
- Establishes strategic supplier relationships to ensure supplier and external manufacturing, packaging and testing support service providers meet quality and compliance objectives.
- Manages the strategy and relationship to ensure that compliant systems and processes are in place from development through commercialization.
- Establishes strategic focus for Supplier and External Manufacturing Quality Engineering initiatives. Provides leadership to define product and process quality objectives and deploy resources to ensure they are achieved.
- Administers regulatory requirements and J&J Policy and Standards to ensure the compliance and business needs are met. Manages these needs to optimize continued growth at supplier and contractor locations.
- Establishes the systemic approach and policies for evaluating and selecting potential suppliers, external manufactures, development partners, acquisitions and alliances.
- Directs and conducts GMP assessments for potential Licensing & Acquisition (L&A) candidates, development partners, and external manufacturers.
- Leads innovative initiatives in supporting the achievement of worldwide business strategies and objectives.
- Lead and support external Regulatory compliance audits of the Zug site for DCF, GEO, and Cilag with regards to Purchasing Controls.
- Develops best in class supplier quality & external manufacturing compliance professionals who provide quality system expertise ensuring that LifeScan products delight our customers by meeting their needs including quality, compliance and supply.
- Act as delegate for the VP of External Operations and Supplier Quality
People Responsibilities
- Recruitment and induction of new staff
- Performance appraisal, people development / training and succession planning
- Team communication
- Performance management
- Developing the culture within teams and departments
- Rewarding performance of staff
- Administration for team members (eg. holidays, sick pay, family and parental leave, expenses, attendance management etc.)
- Termination and transfers of staff
Qualifications
- BS/BA, degree in science, technology, or engineering or equivalent is required. Graduate degree/studies in related discipline / MBA preferred
- Minimum of 10 years of business experience is required. Experience in QRC, R&D, or Supply Chain roles preferred.
- Extensive experience in FDA regulated industry (preferably with both electronic devices and in vitro diagnostics) including experience in the interpretation and application of the medical device GMP regulations is required.
- Demonstrated competency of Risk Management practices, Corrective and Preventative Actions, and regulatory requirements such as FDA QSR’s, ISO 13485:2003 is required.
- Demonstrated ability to work remotely and partner globally is required.
- Ability to lead, negotiate and influence others in a complex matrix organization is required.
- Ability to communicate clearly and concisely across all levels of the company and across the global MD&D supply chain is required.
- Ability to foster an effective multi-functional, cross region, cross company team environment is required.
- Excellent listening, analytical, facilitation and organizational skills are required.
- Strong collaboration, influencing and relationship development skills are required.
- Outstanding presence and communication skills, including the ability to inspire trust and quickly build credibility, are required.
- Strategic thinking ability complemented by hands-on operational and business planning orientation is required. Strong background in Process Excellence, Six Sigma, Lean methodologies or operational excellence is preferred
- Six Sigma GB or BB certification is preferred.
- ASQ Certification is a preferred.
This position will be based in Zug, Switzerland.
Up to 40% EMEA and international travel is required.
BE VITAL in your career. Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
AD CODE: J2W: JOBSCH
Primary Location:Europe/Middle East/Africa-Switzerland-Zug-Zug
Organization: Cilag GmbH International (8525)
Job Function: Quality (Eng)