Enterprise Quality R&D Clinical Computer System Validation (CSV) Manager

Role Summary

Enterprise Quality R&D Clinical Computer System Validation (CSV) Manager responsible for guiding and managing the project team throughout the end-to-end lifecycle of quality into enterprise-wide systems, tools, services and infrastructure (design, develop, implement, maintain, retire). Located in Horsham, PA; Raritan, NJ; Beerse, Belgium or Allschwil, Switzerland.

Responsibilities

• This role must ensure that all J&J quality standards and global regulatory requirements are being met
• This role ensures that building and execution activities include early involvement of quality in the design and development activities, building quality into the work product, building controls within the application/solution, and use of automation whenever feasible
• This individual will own the quality approach for systems and ensure teams are accountable for delivering on an end-to-end support model for systems in scope
• The role provides technical and procedural expertise/guidance to the project teams as well as aligning with both internal and external stakeholders
• The role is responsible for planning, task and resource allocations, executing, coordinating and maintaining the validation activities for GxP systems/applications
• This position will support internal audits and Health Authority regulatory inspections
• This position will be responsible for the approval of SDLC validation documentation deliverables including the approval to release system implementation and/or changes for production use, will attend project team meetings and provide EQ compliance guidance and support to project and base business support team members
• This role will lead globally diverse teams in an inclusive environment
• This role will provide an environment which encourages the company‚Äôs credo and the value of a diverse workforce

Qualifications

Education

• Bachelor‚Äôs or equivalent degree in Computer Science, Information Systems, Business Administration, Science, Engineering or another related field is required.

Experience And Skills

• Required: 8-10 years of progressive experience in the pharmaceutical/medical device/biotech industry, with direct experience in Computerized System Validation activities
• Required: Experience in running large scale end-to-end Validation programs is required such as LIMS, CAPA, MES, PLM, SAP, LMS, Complaints Handling, and Change Control
• Required: Experience authoring or approving validation protocols, non-conformities, Change Requests, SOPs, Validation Plans and Reports
• Required: Proficiency using the following tools is highly desirable: JIRA, HPALM, Xray, Qtest, Jenkins, Selenium
• Required: Direct experience working in a software development environment using Agile, SAFe, CI/CD
• Required: Direct experience in Artificial Intelligence (AI) and Machine Learning (ML)
• Required: Direct experience in CSV Quality and/or CSV for R&D systems
• Required: Thorough knowledge of cGMP regulations related to CSV, including 21 CFR Part 11, Part 210, Part 211 and Part 820
• Required: Knowledge of SDLC Quality Management process and Computerized System Validation/Computerized System Assurance principles
• Preferred: Understands data integrity needed throughout the lifecycle of a technology solution
• Preferred: Defines strategy for testing according to the risk assessment
• Preferred: Experience in Testing Management tools like HPALM, JIRA with Xray, Selenium
• Preferred: Implements elements of an effective quality management system to the organization and its technology solutions
• Preferred: Able to apply digitization tools and techniques to automate, simplify, digitize and enhance software development and validation processes
• Preferred: Understands and applies best practices for architecting effective data solutions and frameworks that enable high quality data
• Preferred: Working knowledge of other Global Regulations like EU Annex 11, SOX, HCC, Security & Privacy, ISO
• Preferred: Working knowledge of PMO, SDLC, GAMP 5, and ITIL frameworks is highly desirable
• Preferred: Knowledge of Agile, SAFe, CI/CD, RPA, Cloud Storage and Computing, IoT, Data & Analytics, AI, Intelligent Automation, Blockchain, Kubernetes, XaaS, SaMD

Skills

• Compliance Management
• Corrective and Preventive Action (CAPA)
• Cross-Functional Collaboration
• Developing Others
• Fact-Based Decision Making
• Give Feedback
• Good Manufacturing Practices (GMP)
• Inclusive Leadership
• ISO 9001
• Leadership
• Quality Control (QC)
• Quality Management Systems (QMS)
• Quality Standards
• Quality Validation
• Risk Assessments
• Standard Operating Procedure (SOP)
• Tactical Thinking
• Team Management

Education

• Bachelor‚Äôs or equivalent degree in Computer Science, Information Systems, Business Administration, Science, Engineering or another related field is required.

Additional Requirements

• Proficiency in the English language, both written and oral, is required
• Up to 10% travel both international and domestic may be required
• May have 0-1 direct reports