IT Lead GxP Capabilities-00000S64
Description
DePuy Synthes Companies of Johnson & Johnson is the largest, most comprehensive orthopaedic and neurological business in the world. DePuy Synthes Companies offer an unparalleled breadth and depth of technology, devices, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, neurological, cranio-maxillofacial, power tools and biomaterials. Our broad array of inspired, innovative and high-quality offerings help advance the health and wellbeing of people around the world.
OVERALL RESPONSIBILITIES:
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
- Support the development of 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
PROFESSIONAL EXPERIENCE REQUIREMENTS:
- Direct experience with computer systems validation of applications in the life sciences industry
- 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
- Direct experience with project management of GXP validations and familiarization with all phases of project development using J&J SDLC(Software Development Lifecycle) is highly desired
- Prior experience with developing reusable frameworks and materials to support organizational change and learning
EDUCATIONAL REQUIREMENTS:
- Approximate experience or equivalent knowledge and skills necessary to satisfactorily perform the position responsibilities
- 4+ years with Information Technology or associate degree
- 4+ years with advanced degree or equivalent preferred.
OTHER REQUIREMENTS
- Strong written and verbal communication skills in English and intermediate German
- Ability to interact at all levels of management
- Strong leadership skills and resilience in the face of significant organizational transformation
Primary Location:Europe/Middle East/Africa-Switzerland-Solothurn-Zuchwil
Organization: Synthes GmbH (7111)
Job Function: Info Technology
Description
DePuy Synthes Companies of Johnson & Johnson is the largest, most comprehensive orthopaedic and neurological business in the world. DePuy Synthes Companies offer an unparalleled breadth and depth of technology, devices, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, neurological, cranio-maxillofacial, power tools and biomaterials. Our broad array of inspired, innovative and high-quality offerings help advance the health and wellbeing of people around the world.
OVERALL RESPONSIBILITIES:
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
- Support the development of 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
PROFESSIONAL EXPERIENCE REQUIREMENTS:
- Direct experience with computer systems validation of applications in the life sciences industry
- 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
- Direct experience with project management of GXP validations and familiarization with all phases of project development using J&J SDLC(Software Development Lifecycle) is highly desired
- Prior experience with developing reusable frameworks and materials to support organizational change and learning
EDUCATIONAL REQUIREMENTS:
- Approximate experience or equivalent knowledge and skills necessary to satisfactorily perform the position responsibilities
- 4+ years with Information Technology or associate degree
- 4+ years with advanced degree or equivalent preferred.
OTHER REQUIREMENTS
- Strong written and verbal communication skills in English and intermediate German
- Ability to interact at all levels of management
- Strong leadership skills and resilience in the face of significant organizational transformation
Primary Location:Europe/Middle East/Africa-Switzerland-Solothurn-Zuchwil
Organization: Synthes GmbH (7111)
Job Function: Info Technology