Johnson & Johnson companies are equal opportunity employers.
World Wide CAPA Manager-7975140407
Description
DePuy Synthes is seeking a World Wide CAPA Manager to be located in West Chester, PA, Raynham, MA, Warsaw, IN, Cork, Ireland or Zuchwil, Switzerland.
DePuy Synthes Companies of Johnson & Johnson is the largest, most innovative and comprehensive orthopaedic and neurological business in the world. DePuy Synthes Companies will offer an unparalleled breadth and depth of products, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, neurological, craniomaxillofacial, power tools and biomaterials. Building on the legacy and strengths of two great companies, we are creating one organization that will be agile and better equipped in today’s evolving health care environment. With a focus on activating insights to develop innovative, comprehensive solutions, we are inspired to advance patient care in greater ways than either company could accomplish on its own.
The World Wide CAPA Manager will provide ongoing strategic review and continuous improvement of the Global Orthopaedic CAPA process in line with Global Orthopaedic and Sector standardization initiatives utilizing robust project management methodologies. He/she will ensure the continuous implementation/ improvement of Quality Systems efforts through the CAPA process.
The World Wide CAPA Manager will design, develop and implement standardized procedures, processes and systems for CAPA across DePuy Synthes. He/she will maintain overall management and effectiveness of the CAPA system including the process and application. This individual will ensure processes are in place to alert management of product quality & compliance issues for proper and timely escalation to CAPA. The World Wide CAPA Manager will develop and implement measures to monitor the effectiveness of the CAPA system. Ensure results of verification and monitoring of the effectiveness of CAPA and its compliance to applicable regulations and standards of monitoring process are routinely communicated to management. He/she will facilitate Change Management activities resulting from the standardisation of the CAPA process and associated systems across DePuy Synthes. This individual will form and Lead the CAPA DePuy Synthes working group.
The World Wide CAPA Manager will partner with other management personnel in formulating and establishing DePuy Synthes policies, procedures, and quality objectives as well as with the DePuy Synthes Quality System Development team to align on system requirements to support the CAPA process. He/she will standardize and leverage MD&D compliance policies, practices, metrics and resources across the sector in alignment with the enterprise standards. This individual will be responsible for identification and leadership of tactical continuous improvement opportunities. The World Wide CAPA Manager will identify opportunities for procedural harmonization and integration. Identify and establish best practices, ensuring J&J best practices are utilized throughout DePuy Synthes. He/she will establish Global initiative to develop and deliver best in class education and training for all CAPA users to deliver consistent CAPAs compliant with DePuy Synthes standards and Medical Device Regulations. This individual will ensure regulatory inspection readiness plans are in place across DePuy Synthes in preparation for regulatory inspection (internal and external).
The World Wide CAPA Manager will act as subject matter expert for CAPA processes to key stakeholders and for external regulatory inspections. He/she will partner on the formulation of responses to regulatory agencies in order to address CAPA related observations. This individual will collaborate in the identification and implementation of corrective actions. He/she will ensure effective and timely completion of all corrective actions. This individual will provide leadership, oversight and strategic guidance for significant regulatory compliance issues across the operating companies in DePuy Synthes. The World Wide CAPA Manager will maintain current knowledge of regulatory changes through industry publications, seminars, professional affiliation and industry meetings. He/she will support DePuy Synthes objectives while adhering to the values of the Johnson & Johnson Credo and local safety and environmental policy and procedure. This individual will carry out strategic planning and development process on a continuous basis, analysis, definition and PMO leadership as well as quality system due diligence and integration activities as required by the business. The World Wide CAPA Manager will ensure emerging regulatory requirements are addressed in a proactive and effective manner. He/she will perform financial planning and overall budget management. This individual will represent Quality as required on quality and business teams throughout DePuy Synthes, MD&D and J&J Enterprise.
Qualifications
A minimum of a Bachelors Degree is required. A Bachelors Degree in science, engineering, or equivalent is strongly preferred. A Post Graduate Qualification in Quality / Regulatory is preferred. A minimum of 10 years experience in a GMP and/or ISO regulated environment is required, with at least 2 of those 10 years in a CAPA focused role for the medical device industry. A minimum of 5 years management experience is required. Expert knowledge of the US Quality System Regulations and ISO 13485 is required. Working knowledge of ISO 14971 and the Quality System Regulations is required. Strong knowledge of CAPA, quality and compliance in a regulated manufacturing environment (GMP/ISO) is required. Working knowledge of related functions such as Product Development, Operations, Supplier Management and Procurement is preferred. Experience in auditing to FDA QSR and ISO standards, additionally a working knowledge of PAL and other related medical device national regulatory standards is required. Demonstrated knowledge of business impact of compliance issues and CAPA is required. Proven ability to build partnerships both internally and externally is required. Process Excellence Black Belt Certification is preferred. Strong compliance management track record is required. Demonstrated leadership and people management ability in a multi-regional/global organization is required. Strong change management skills are required. Excellent communication skills, to quickly build credibility within the Quality and Compliance community, executive management, external regulators, and industry – Both verbal and written are required. Strong collaboration and influencing skills to partner effectively with Sector functions and across Operating Units – Both internally and externally is required. Team building and development capabilities are required. System design and management skills – Organizational and Quality Systems is required. Demonstrated track record of delivering best in class results in the Quality Systems area is required.
This role will be based in West Chester, PA, Raynham, MA, Cork, Ireland or Zuchwil, Switzerland. The role requires up to 30% travel, including international.
BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
J2W: LI NA
J2W: LI EMEA
Primary Location:North America-United States-Pennsylvania-West Chester
Organization: Depuy Orthopaedics. Inc. (6029)
Job Function: Quality Systems
Travel:Yes, 25 % of the Time
Certain sites within the Johnson & Johnson Family of Companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.
Johnson and Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status, or any other characteristic protected by law.
EEO is the Law
EEO is the Law GINA Supplement
World Wide CAPA Manager-7975140407
Description
DePuy Synthes is seeking a World Wide CAPA Manager to be located in West Chester, PA, Raynham, MA, Warsaw, IN, Cork, Ireland or Zuchwil, Switzerland.
DePuy Synthes Companies of Johnson & Johnson is the largest, most innovative and comprehensive orthopaedic and neurological business in the world. DePuy Synthes Companies will offer an unparalleled breadth and depth of products, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, neurological, craniomaxillofacial, power tools and biomaterials. Building on the legacy and strengths of two great companies, we are creating one organization that will be agile and better equipped in today’s evolving health care environment. With a focus on activating insights to develop innovative, comprehensive solutions, we are inspired to advance patient care in greater ways than either company could accomplish on its own.
The World Wide CAPA Manager will provide ongoing strategic review and continuous improvement of the Global Orthopaedic CAPA process in line with Global Orthopaedic and Sector standardization initiatives utilizing robust project management methodologies. He/she will ensure the continuous implementation/ improvement of Quality Systems efforts through the CAPA process.
The World Wide CAPA Manager will design, develop and implement standardized procedures, processes and systems for CAPA across DePuy Synthes. He/she will maintain overall management and effectiveness of the CAPA system including the process and application. This individual will ensure processes are in place to alert management of product quality & compliance issues for proper and timely escalation to CAPA. The World Wide CAPA Manager will develop and implement measures to monitor the effectiveness of the CAPA system. Ensure results of verification and monitoring of the effectiveness of CAPA and its compliance to applicable regulations and standards of monitoring process are routinely communicated to management. He/she will facilitate Change Management activities resulting from the standardisation of the CAPA process and associated systems across DePuy Synthes. This individual will form and Lead the CAPA DePuy Synthes working group.
The World Wide CAPA Manager will partner with other management personnel in formulating and establishing DePuy Synthes policies, procedures, and quality objectives as well as with the DePuy Synthes Quality System Development team to align on system requirements to support the CAPA process. He/she will standardize and leverage MD&D compliance policies, practices, metrics and resources across the sector in alignment with the enterprise standards. This individual will be responsible for identification and leadership of tactical continuous improvement opportunities. The World Wide CAPA Manager will identify opportunities for procedural harmonization and integration. Identify and establish best practices, ensuring J&J best practices are utilized throughout DePuy Synthes. He/she will establish Global initiative to develop and deliver best in class education and training for all CAPA users to deliver consistent CAPAs compliant with DePuy Synthes standards and Medical Device Regulations. This individual will ensure regulatory inspection readiness plans are in place across DePuy Synthes in preparation for regulatory inspection (internal and external).
The World Wide CAPA Manager will act as subject matter expert for CAPA processes to key stakeholders and for external regulatory inspections. He/she will partner on the formulation of responses to regulatory agencies in order to address CAPA related observations. This individual will collaborate in the identification and implementation of corrective actions. He/she will ensure effective and timely completion of all corrective actions. This individual will provide leadership, oversight and strategic guidance for significant regulatory compliance issues across the operating companies in DePuy Synthes. The World Wide CAPA Manager will maintain current knowledge of regulatory changes through industry publications, seminars, professional affiliation and industry meetings. He/she will support DePuy Synthes objectives while adhering to the values of the Johnson & Johnson Credo and local safety and environmental policy and procedure. This individual will carry out strategic planning and development process on a continuous basis, analysis, definition and PMO leadership as well as quality system due diligence and integration activities as required by the business. The World Wide CAPA Manager will ensure emerging regulatory requirements are addressed in a proactive and effective manner. He/she will perform financial planning and overall budget management. This individual will represent Quality as required on quality and business teams throughout DePuy Synthes, MD&D and J&J Enterprise.
Qualifications
A minimum of a Bachelors Degree is required. A Bachelors Degree in science, engineering, or equivalent is strongly preferred. A Post Graduate Qualification in Quality / Regulatory is preferred. A minimum of 10 years experience in a GMP and/or ISO regulated environment is required, with at least 2 of those 10 years in a CAPA focused role for the medical device industry. A minimum of 5 years management experience is required. Expert knowledge of the US Quality System Regulations and ISO 13485 is required. Working knowledge of ISO 14971 and the Quality System Regulations is required. Strong knowledge of CAPA, quality and compliance in a regulated manufacturing environment (GMP/ISO) is required. Working knowledge of related functions such as Product Development, Operations, Supplier Management and Procurement is preferred. Experience in auditing to FDA QSR and ISO standards, additionally a working knowledge of PAL and other related medical device national regulatory standards is required. Demonstrated knowledge of business impact of compliance issues and CAPA is required. Proven ability to build partnerships both internally and externally is required. Process Excellence Black Belt Certification is preferred. Strong compliance management track record is required. Demonstrated leadership and people management ability in a multi-regional/global organization is required. Strong change management skills are required. Excellent communication skills, to quickly build credibility within the Quality and Compliance community, executive management, external regulators, and industry – Both verbal and written are required. Strong collaboration and influencing skills to partner effectively with Sector functions and across Operating Units – Both internally and externally is required. Team building and development capabilities are required. System design and management skills – Organizational and Quality Systems is required. Demonstrated track record of delivering best in class results in the Quality Systems area is required.
This role will be based in West Chester, PA, Raynham, MA, Cork, Ireland or Zuchwil, Switzerland. The role requires up to 30% travel, including international.
BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
J2W: LI NA
J2W: LI EMEA
Primary Location:North America-United States-Pennsylvania-West Chester
Organization: Depuy Orthopaedics. Inc. (6029)
Job Function: Quality Systems
Travel:Yes, 25 % of the Time
Certain sites within the Johnson & Johnson Family of Companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.
Johnson and Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status, or any other characteristic protected by law.
EEO is the Law
EEO is the Law GINA Supplement