Computer System Validation Lead, Adverse
il y a 1 semaine
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.
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
- 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
- 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
**Qualifications**:
**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
**Preferred**:
- Working knowledge of other Global Regulations like EU Annex 11, SOX, HCC, Security & Privacy, ISO
- Experience in large scale end-to-end Validation programs like LIMS,
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