Technical Property Manager overseeing technical management of commercial properties. Collaborating with stakeholders and ensuring compliance with regulations in Düsseldorf, Germany.
ON
Hybrid Enterprise Quality R&D Clinical Computer System Validation Manager
Posted last month
About the role
- CSV Manager ensuring compliance and quality validation for enterprise systems at Johnson & Johnson. Leading project teams and maintaining regulatory standards in healthcare technology.
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.
- 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.
Requirements
- 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.
Benefits
- 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 period10 days Volunteer Leave – 32 hours per calendar year Military Spouse Time-Off – 80 hours per calendar year
Job title
Job type
Experience level
Salary
Degree requirement
Tech skills
Location requirements
Store Manager responsible for recruiting, training, and supervising staff at Circle K in Mankato. Ensuring excellent customer service and optimizing store operations.
Store Manager responsible for retail management at Circle K locations in Minnesota. Training staff, managing sales, and ensuring operational efficiency.
F&B Manager overseeing operational and economic processes in Food & Beverage at Frankfurt airport. Collaborating with teams to optimize efficiency, quality, and costs in a dynamic environment.
Store Manager overseeing daily business operations and team development in textile retail. Responsible for merchandising, staff planning, financial analysis, and active selling in Schwerin.
General Manager leading team and managing budget and restaurant operations in a vibrant Italian restaurant. Ensuring quality service and overseeing team development with a focus on guest experience.
Assistant Manager responsible for high - quality guest experiences at L’Osteria. Leading operational support and team management in Dresden, Germany.
Store Manager responsible for overseeing operations and team development at ONLY & SONS retail shop in Ravensburg, ensuring effective merchandising and sales management.
Assistant General Manager responsible for restaurant operations and team development in a hospitality environment. Join a strong team with opportunities for career advancement and flexible work.
Store Manager responsible for shop management and developing a team in Ravensburg. Leading merchandising, business coordination, and effective staff planning for the fashion retail sector.