Johnson & Johnson companies are equal opportunity employers.
IT Lead, GXP Capabilities-1540140205
Description
DePuy Synthes is currently recruiting for an IT Lead, GXP Capabilities located in West Chester, PA. DePuy Synthes Companies of Johnson & Johnson is the largest, most innovative and comprehensive orthopaedic and neurological business in the world.
DePuy Synthes Companies 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, more agile and better equipped to meet the needs of 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.
Responsible to develop and support the Legacy Synthes IT organizational GXP capabilities as outlined in local System Development (ICDS WG-S166) and related control procedures. Work closely with the QA Computer Systems Compliance and Business community to ensure effective coordination of accountabilities to maintain validation and control of DePuy Synthes GXP solutions.
POSITION DUTIES & RESPONSIBILITIES:
Coach and support organizational understanding, adherence and effectiveness of ICDS WG-S166 (SDLC) and WG-S186 (Change Control) within the Legacy Synthes QMS scope; Develop and maintain IT-related support procedures to ensure sustainability of demonstrated control and validation of our Legacy Synthes technical solutions across the Legacy Synthes Quality Management; Systems and in anticipation of future QMS integration; Develop reusable materials and examples to compliment and support WG-S166 and the J&J SDLC; Develop in conjunction with the PMO measures and metrics to demonstrate state of the organizational capability; Create a culture of quality within IT using existing J&J Q&C materials (Five Quality Principles and CoQ toolkit) as well as relevant local material; Support the transformation process from Legacy Synthes IT to IT Shared Services as it relates to GXP systems; Partner closely within IT (DePuy Synthes, Supply Chain, J&J IT) to leverage and align efforts; Know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics and compliance at all times; Diligently participate in our compliance program-related activities as denoted by your supervisor or our Chief Compliance Officer.
Qualifications
Approximate experience, or equivalent knowledge and skills, necessary to satisfactorily perform the position responsibilities: 6+ years with four-year degree or equivalent preferred or 4+ years with advanced degree or equivalent preferred. Direct experience with computer systems validation of applications in the life sciences industry is required. Demonstrated understanding of FDA and ISO applicable regulations and specifically related to GXP and 21 CFR Part 11, disaster recovery, change control and application/Infrastructure qualifications is an asset. Direct experience with project management of GXP validations and familiar with all phases of project development using J&J SDLC is strongly preferred. Prior experience with developing reusable frameworks and materials to support organizational change and learning is also preferred. Strong written and verbal communication skills are required. The ability to interact with all levels of management is required. Strong leadership skills and resilience in the face of significant organizational transformation is also required. This position will be based in West Chester, PA and may require travel up to 10% domestic travel.
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
Primary Location:North America-United States-Pennsylvania-West Chester
Organization: Depuy Orthopaedics. Inc. (6029)
Job Function: IT Compliance
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
IT Lead, GXP Capabilities-1540140205
Description
DePuy Synthes is currently recruiting for an IT Lead, GXP Capabilities located in West Chester, PA. DePuy Synthes Companies of Johnson & Johnson is the largest, most innovative and comprehensive orthopaedic and neurological business in the world.
DePuy Synthes Companies 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, more agile and better equipped to meet the needs of 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.
Responsible to develop and support the Legacy Synthes IT organizational GXP capabilities as outlined in local System Development (ICDS WG-S166) and related control procedures. Work closely with the QA Computer Systems Compliance and Business community to ensure effective coordination of accountabilities to maintain validation and control of DePuy Synthes GXP solutions.
POSITION DUTIES & RESPONSIBILITIES:
Coach and support organizational understanding, adherence and effectiveness of ICDS WG-S166 (SDLC) and WG-S186 (Change Control) within the Legacy Synthes QMS scope; Develop and maintain IT-related support procedures to ensure sustainability of demonstrated control and validation of our Legacy Synthes technical solutions across the Legacy Synthes Quality Management; Systems and in anticipation of future QMS integration; Develop reusable materials and examples to compliment and support WG-S166 and the J&J SDLC; Develop in conjunction with the PMO measures and metrics to demonstrate state of the organizational capability; Create a culture of quality within IT using existing J&J Q&C materials (Five Quality Principles and CoQ toolkit) as well as relevant local material; Support the transformation process from Legacy Synthes IT to IT Shared Services as it relates to GXP systems; Partner closely within IT (DePuy Synthes, Supply Chain, J&J IT) to leverage and align efforts; Know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics and compliance at all times; Diligently participate in our compliance program-related activities as denoted by your supervisor or our Chief Compliance Officer.
Qualifications
Approximate experience, or equivalent knowledge and skills, necessary to satisfactorily perform the position responsibilities: 6+ years with four-year degree or equivalent preferred or 4+ years with advanced degree or equivalent preferred. Direct experience with computer systems validation of applications in the life sciences industry is required. Demonstrated understanding of FDA and ISO applicable regulations and specifically related to GXP and 21 CFR Part 11, disaster recovery, change control and application/Infrastructure qualifications is an asset. Direct experience with project management of GXP validations and familiar with all phases of project development using J&J SDLC is strongly preferred. Prior experience with developing reusable frameworks and materials to support organizational change and learning is also preferred. Strong written and verbal communication skills are required. The ability to interact with all levels of management is required. Strong leadership skills and resilience in the face of significant organizational transformation is also required. This position will be based in West Chester, PA and may require travel up to 10% domestic travel.
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
Primary Location:North America-United States-Pennsylvania-West Chester
Organization: Depuy Orthopaedics. Inc. (6029)
Job Function: IT Compliance
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