About the role

Enterprise Quality R&D Clinical Computer System Validation Manager ensuring compliance with quality standards across systems and regulatory requirements. Leading diverse teams and supporting GxP validation activities.

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
Plan, 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
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

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 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.
Proficiency in the English language, both written and oral, is required.

Subject to the terms of their respective plans, employees are eligible to participate in the Company’s 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 –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 period
10 days Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year