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

7555-Janssen Pharmaceutica NV Legal Entity; Geel; Sur place; EUR 101 000 - 152 000; Plein temps

Avantages offerts par ce poste

Annual bonus

Vacation days

Parental leave

Résumé du poste

Johnson & Johnson is seeking an Enterprise Quality R&D Clinical Computer System Validation (CSV) Manager. The role can be located in Horsham, PA; Raritan, NJ; Beerse, Belgium or Allschwil, Switzerland and may be posted under different requisitions to fit local requirements.

The incumbent will guide validation across enterprise IT systems, ensuring compliance with SDLC/CSV frameworks, participating in audits, and leading diverse teams to embed quality into end-to-end processes.

Qualifications

• Education: Bachelor’s or equivalent degree in Computer Science, Information Systems, Business Administration, Science, Engineering or another related field is required.
• Experience: 8–10 years in pharmaceutical/medical device/biotech with direct CSV experience.
• Experience leading large end-to-end Validation programs (LIMS, CAPA, MES, SAP, LMS, Change Control).
• Proficiency with CSV tools and SDLC Quality Management; knowledge of 21 CFR Part 11 and EU Annex 11.

Responsabilités

• Ensure all Johnson & Johnson quality standards and global regulatory requirements are met.
• Own quality approach for systems and end-to-end support model for scope systems.
• Lead global, diverse teams; provide guidance to project teams and stakeholders.
• Plan, allocate resources, and manage validation activities for GxP systems and applications.
• Support internal audits and Health Authority inspections; approve validation deliverables.

Connaissances

Controls Compliance

Developing Others

Empowering People

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

Leadership

Inclusive Leadership

HCI (Human-Computer Interaction)

Formation

Bachelor’s degree in Computer Science, Information Systems, Business Administration, Science, Engineering or another related field

Outils

JIRA

HPALM

Xray

Qtest

Jenkins

Selenium

Description du poste

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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 jnj.com. As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

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

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 – 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’s 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’s 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’s 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

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers. Internal employees contact AskGS to be directed to your accommodation resource.

Required and 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

Pay Range:

The anticipated pay ranges for this position, in the primary posting location, is: The anticipated pay ranges for additional locations are: The anticipated base pay range for this position is 117,000 to 175,800.

Benefits:

• an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions.
• vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement, programs for financial, physical and mental health.
• We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans.

Additional information: In addition to base pay, we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions. Moreover, we offer vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement, programs for financial, physical and mental health. We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans. For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers. *This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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/.

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