Computer System Validation Lead, Adverse Events/Complaint Mgt in EMEA

at  Johnson Johnson

Johnson & Johnson is recruiting for a Computer System Validation Lead, Complaints / Adverse Events in EU (Switzerland or Belgium), near a J&J office.
Per our J&J Flex Policy, the expectation for this position is to work in the nearest Johnson and Johnson office 3-4 days per week and work from home 1-2 days per week.
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.
Enterprise Quality is a comprehensive organization within J&J that focuses on ensuring the highest standards of quality & compliance. It encompasses a Quality Operations division that handles Computer System Validation (CSV), QMS Management, and Commercial Quality Shared Services, including specialized support for Transportation Operations and Temperature Control. Additionally, it includes a Transformation Office dedicated to steering strategic imperatives and enhancing the Quality & Compliance organization’s strategy through initiatives like Data Strategy, Automated Product Release, and Digitalization of Quality Management Systems. The group further comprises a Data & Digital Strategy function tasked with developing and executing a holistic digital and data strategy to improve quality and compliance, covering areas such as Data Foundations, AI/ML & IoT technologies, Quality & Compliance Innovation, and Digital Assets validation. To facilitate the deployment of these strategic initiatives, the group employs two Deployment Offices for the MedTech and MedTech segments and maintains a global presence through three regional leaders managing operations in Asia Pacific (ASPAC), Europe, Middle East, Africa (EMEA), and the Americas. This position will require up to 20% travel.
Within Enterprise Quality (EQ), the IM Deployment office drives targeted strategic transformation and quality operations (CSV) initiatives aligned with the Innovative Medicine (IM) segment strategic priorities.

The Lead, Complaints / Adverse Events is responsible for guiding and managing the team throughout the building and execution of quality into enterprise wide systems, tools, services and infrastructure through the end-to-end lifecycle (design, develop, implement, maintain, retire).The Lead, Complaints / Adverse Events will:

• Ensure that all J&J quality standards and global regulatory requirements are met
• Ensure building and execution activities involve early quality involvement in design and development, integrating quality into work products, implementing controls within applications/solutions, and leveraging automation when feasible
• Own the quality approach for systems and hold teams accountable for delivering an end-to-end support model
• Provide technical and procedural expertise/guidance to project teams, aligning with internal and external stakeholders
• Plan, allocate tasks and resources, execute, coordinate, and maintain validation activities for GxP systems/applications
• Support internal audits and Health Authority regulatory inspections
• Approve SDLC validation documentation deliverables, including release of system implementations/changes for production
• Attend project team meetings, offering EQ quality and compliance guidance and support
• Collaborate with globally diverse teams in an inclusive environment
• Promote an environment fostering the company’s credo and the value of a diverse workforce
• Serve as a trusted partner across the Enterprise Quality organization, fostering strong collaboration skills at the project team level, internally and externally
• Develop and maintain an effective working partnership with senior management
• Collaborate with other leaders and staff within IM Deployment Office and Quality Operations group to ensure each function is executed in an efficient manner
• Ensure timely reports of status and metrics as required by the IM Deployment Office organization
• Ensure timely completion of assigned training and expense reports

REQUIREMENTS:

• A bachelor’s degree in computer science, Information Systems, Business Administration or another related field required. Solid, relevant experience may be substituted when appropriate, additional certifications a plus
• 6+ years of progressive experience in the pharmaceutical/medical device/biotech industry, with direct experience in Computerized System Validation activities
• Experience authoring or approving validation protocols, non-conformities, Change Requests, SOPs, Validation Plans and Reports
• Project Management experience
• Ability to make decisions by seeking out and maintaining trusting and collaborative relationships to meet business needs and demands
• Superior written and oral communication skills
• Ability to perform work with a high degree of independence in terms of self-management of a large variety of tasks and initiatives regarding quality and validation
• Ability to manage multiple and competing projects
• Knowledge of SDLC Quality Management process and Computerized System Validation/Computerized System Assurance principles
• Thorough knowledge of cGMP regulations related to CSV, including 21 CFR Part 11, Part 210, Part 211 and Part 820
• Experience working effectively in a highly matrixed team environment
• Project management and organizational skills

• Ensure that all J&J quality standards and global regulatory requirements are met
• Ensure building and execution activities involve early quality involvement in design and development, integrating quality into work products, implementing controls within applications/solutions, and leveraging automation when feasible
• Own the quality approach for systems and hold teams accountable for delivering an end-to-end support model
• Provide technical and procedural expertise/guidance to project teams, aligning with internal and external stakeholders
• Plan, allocate tasks and resources, execute, coordinate, and maintain validation activities for GxP systems/applications
• Support internal audits and Health Authority regulatory inspections
• Approve SDLC validation documentation deliverables, including release of system implementations/changes for production
• Attend project team meetings, offering EQ quality and compliance guidance and support
• Collaborate with globally diverse teams in an inclusive environment
• Promote an environment fostering the company’s credo and the value of a diverse workforce
• Serve as a trusted partner across the Enterprise Quality organization, fostering strong collaboration skills at the project team level, internally and externally
• Develop and maintain an effective working partnership with senior management
• Collaborate with other leaders and staff within IM Deployment Office and Quality Operations group to ensure each function is executed in an efficient manner
• Ensure timely reports of status and metrics as required by the IM Deployment Office organization
• Ensure timely completion of assigned training and expense report