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

Johnson & Johnson Innovative Medicine•Horsham, PA

1d•Hybrid

About The Position

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. This role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. 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).

Requirements

Bachelor’s or equivalent degree in Computer Science, Information Systems, Business Administration, Science, Engineering or another related field is 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 in the English language, both written and oral, is required.

Nice To Haves

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.
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.

Responsibilities

Ensure that all J&J quality standards and global regulatory requirements are being met.
Ensure 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.
Own the quality approach for systems and ensure teams are accountable for delivering on an end-to-end support model for systems in scope.
Provide technical and procedural expertise/guidance to the project teams as well as aligning with both internal and external stakeholders.
Responsible for planning, task and resource allocations, executing, coordinating and maintaining the validation activities for GxP systems/applications.
Support internal audits and Health Authority regulatory inspections.
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.
Lead globally diverse teams in an inclusive environment.
Provide an environment which encourages the company’s credo and the value of a diverse workforce.
Serve 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.

Benefits

Employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period10 days
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year