Group Director, Quality Systems and Compliance Job
Location: Somerville New Jersey
Description: Johnson & Johnson is at present looking to employ Group Director, Quality Systems and Compliance Job right now, this career will be placed in New Jersey. Further informations about this career opportunity kindly see the descriptions. Johnson & Johnson companies are equal opportunity employers.
Group Director, Quality Systems and Compliance-5661130816
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Description
The Ethicon Surgical Care business of the Medical Device and Diagnostics sector of Johnson & Johnson is recruiting for a Group Director, Quality Systems and Compliance to be located in Somerville, NJ.
The Ethicon Surgical Care business offers a broad range of products, platforms and technologies-including sutures, surgical staplers, clip appliers, trocars and synthetic mesh devices-that are used in a wide variety of minimally invasive and open surgical procedures. Specialties include support for treatment of colorectal and thoracic conditions, women's health conditions, hernias, cancer and obesity. The Ethicon Surgical Care business combines products and services of two market leading legacy companies, both with long histories of medical innovation. Ethicon, Inc. based in Somerville, New Jersey, was founded more than 80 years ago as a pioneer in suture development and manufacturing, helping to transform the safety and electiveness of open ! surgery. Ethicon Endo-Surgery, Inc. was created 20 years ago i! n Cincinnati, Ohio, developing innovative devices that have driven the revolutionary shift from open to minimally invasive surgery that continues to lead the industry today.
The Group Director, Quality Systems and Compliance is a critical leadership position within the ETHICON business accountable for the effective establishment, maintenance, and continuous improvement of the ETHICON quality systems, including CAPA, Management Review, Escalation, Configuration Management, regulatory compliance processes and procedures that enable the design, manufacture, delivery, and lifecycle management of quality products to customers. This individual partners with the JJQS and JJRC teams in setting ETHICON Quality Systems and compliance strategy, and directs the translation of the strategies into effective quality systems and compliance policies, procedures and business practices to enable the realization of J&J and ETHICON Quality Policy, quality objectives, and business strat! egies.
This position will maintain and continuously improve quality systems to support the development, manufacture and delivery of marketed products in order to meet J&J and external standards, regulatory requirements and customer expectations. This leader will assure that J&J and external regulatory standards are proactively identified and translated into effective and efficient processes and procedures.
This person will maintain and continuously improve regulatory compliance programs across the ETHICON business, manage internal and external audits and external inspection readiness programs, proactively identify potential compliance issues, coordinate recommendations for resolution, and alert senior management to improvement opportunities. The leader will partner with various internal and external functional leaders to develop regulatory inspection strategy, and assure effective follow-up and communication with regulatory bodies and JJRC leaders, and wil! l also partner with Sector JJQS Team to drive harmonization of quality ! systems across the business.
The Group Director will partner with ETHICON leaders to identify required skills and competencies for the organization to allow for the execution of the ETHICON Vision, as well as champion the development of talent within the organization.
This leader’s direct reports include the Director Quality Systems, CAPA Process Leader, Manager Product Escalations, and Director Compliance. This position reports to the ETHICON VP QRC, and is a member of the ETHICON Surgical Care QRC Leadership team, as well as the MD&D Sector-based JJQS and JJRC Working Groups.
Qualifications
A Bachelor’s degree is required. A degree in a scientific or technical field is preferred. An advanced degree is preferred. Six Sigma or PE certification is preferred. A minimum of 10 years of experience is required. Managerial experience is required. Broad experience in all areas of Quality within the medical device, biologics, or other regulate! d industry is required. Demonstrated expertise in the applied interpretation of worldwide regulatory standards is required. Demonstrated expertise in the design, implementation and measurement of quality systems is required.
Initiative in innovative approaches to quality in a fast paced changing business environment is strongly desired. Proven ability to think "Out of box" with strong leadership abilities is required. Demonstrated project management skills with strong ability to negotiate and influence in a highly matrixed environment is required. Ability to effectively present complex information to employees and business unit management is required. Ability to continuously assess the effectiveness of functional processes and to lead progressive improvement initiatives is required. Ability to work collaboratively and in a matrixed environment, building partnership and teamwork across local and global organizations is required.
This position is located in ! Somerville, NJ. Up to approximately 30% domestic and international trav! el may be required.
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Primary Location: North America-United States-New Jersey-Somerville
Organization: Ethicon Inc. (6045)
Job : Quality Systems
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This career starts available on: Sat, 28 Sep 2013 17:42:10 GMT
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