Job Function:
Technology Product & Platform Management
Job Sub Function:
Technology Operations Support
Job Category:
People Leader
All Job Posting Locations:
Allschwil, Basel-Country, Switzerland, Allschwil, Switzerland, Beerse, Antwerp, Belgium, Horsham, Pennsylvania, United States of America, Raritan, New Jersey, United States of America
Job Description:
Johnson and Johnson is recruiting for an Enterprise Quality R&D Clinical Computer System Validation (CSV) Manager, located in either Horsham, PA; Raritan, NJ; Beerse, Belgium or Allschwil, Switzerland.
Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):
United States - Requisition Number: R-093816
Europe 6 Requisition Number: R-094567
Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.
Enterprise Quality (EQ) manages the Quality and Compliance strategy for IT systems including applications, infrastructure and digital health solutions for J&J. EQ is the Subject Matter Expert (SME) for validation/qualification of both applications and infrastructure in accordance with J&J 27s Systems Development Life Cycle (SDLC) and Computer System Validation (CSV) Framework, assuring compliance across the enterprise with applicable global regulations, advising on quality matters, and assisting with closing compliance gaps related to audits and inspections.
The Enterprise Quality R&D Clinical Computer System Validation (CSV) Manager is responsible for guiding and managing the project 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).
Key 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 27s credo and the value of a diverse workforce
This role serves as a trusted partner across the Enterprise Quality organization, requiring strong collaboration skills at the senior leadership level, and includes making recommendations for improvements relevant to senior level stakeholders
Qualifications
Education:
- Bachelor 27s 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
- 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
- Experience authoring or approving validation protocols, non-conformities, Change Requests, SOPs, Validation Plans and Reports
- Proficiency using the following tools is highly desirable: JIRA, HPALM, Xray, Qtest, Jenkins, Selenium
- Direct experience working in a software development environment using Agile, SAFe, CI/CD
- Direct experience in Artificial Intelligence (AI) and Machine Learning (ML)
- Direct experience in CSV Quality and/or CSV for R&D systems
- Thorough knowledge of cGMP regulations related to CSV, including 21 CFR Part 11, Part 210, Part 211 and Part 820
- 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
- Defines strategy for testing according to the risk assessment
- Experience in Testing Management tools like HPALM, JIRA with Xray, Selenium.
- Implements elements of an effective quality management system to the organization and its technology solutions
- Working knowledge/experience in utilization of AI and digital tools
- Able to apply digitization tools and techniques to automate, simplify, digitize and enhance software development and validation processes
- Understands and applies best practices for architecting effective data solutions and frameworks that enable high quality data
- Working knowledge of other Global Regulations like EU Annex 11, SOX, HCC, Security & Privacy, ISO
- Working knowledge of PMO, SDLC, GAMP 5, and ITIL frameworks is highly desirable
- Knowledge of the following technologies and methodologies is highly desirable: Agile, SAFe, CI/CD, RPA, Cloud Storage and Computing, IoT, Data & Analytics, AI, Intelligent Automation, Blockchain, Kubernetes, XaaS, SaMD.
Other:
- 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
Required Skills:
Preferred Skills:
Controls Compliance, Developing Others, Empowering People, Human-Computer Interaction (HCI), Inclusive Leadership, Leadership, Product Knowledge, Product Lifecycle Management (PLM), Program Management, Project Integration Management, Quality Assurance (QA), Resource Planning, Service Request Management, Software Development Management, Team Management, Technical Credibility, Technical Support, Technical Writing
The anticipated base pay range for this position is :
Additional Description for Pay Transparency:
Subject to the terms of their respective plans, employees are eligible to participate in the Company 27s consolidated retirement plan (pension) and savings plan (401(k)).
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
Vacation 6120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado 648 hours per calendar year; for employees who reside in the State of Washington 56 hours per calendar year
Holiday pay, including Floating Holidays 613 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave 6480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave 6240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave 680 hours in a 52-week rolling period10 days
Volunteer Leave 632 hours per calendar year
Military Spouse Time-Off 680 hours per calendar year
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits
