Job Description

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions 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
Job Function: Quality
Job Sub Function: Customer/Commercial Quality
Job Category: Professional
All Job Posting Locations: High Wycombe, Buckinghamshire, United Kingdom
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About Innovative Medicine
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.
Learn more at
We are searching for the best talent for the Quality Management Systems Associate position to be in High Wycombe, UK.
The QMS Associate is responsible for supporting the development and maintenance of the Quality Management System for Janssen UK and Ireland. The successful applicant will help develop and implement strategies to achieve compliance with Regulators, ensuring an inspection-ready culture and is responsible for the continuous improvement of the QMS status of the LOC/Cluster.
As a QMS Associate, you will:
Implement, maintain and monitor the following QMS elements for the Local Operating Company:
Execute requirements regarding lifecycle management of procedural documents and records (creation, approval, distribution, revision, retrieval, retention, disposition, periodic review) to ensure regulatory compliance and business continuity.
Ensure that the J&J Quality Policies and Standards are assessed and aligned for the LOC cluster.
Maintenance of the training curriculums within the electronic Training Management System primarily related to document updates.
Record Coordinator role for the Commercial Quality department.
Monitor Quality System performance versus local GxP and J&J requirements via use of pertinent business and compliance metrics and goals, QMS metrics monitoring and reporting.
Managing the GxP Workbook validation for the LOC.
Ensure appropriate management of QMS records related to own SME area.
Notify the QC Manager and other affected stakeholders with any substantive concerns regarding product quality, safety and/or compliance.
Support the Local Operating Company and EMEA initiatives, such as but not limited to:
Subject Matter Expert support with Health Authority inspections, J&J Corporate Audits and Internal Audits.
Participation in EMEA projects and Community of Practices, as required.
Promote continuous improvement initiatives.
Qualifications / Requirements:
Bachelor's degree in pharmacy, life sciences or related discipline.
Experience in pharmaceutical regulations and processes.
Experience in Quality Assurance and working in cross-functional teams is preferred.
Proficiency is computer systems like MS Office Suites
Strong planning, prioritizing, analytical, and decision-making skills.
Strong verbal and written communication skills.
Teamworking capabilities.
Open for standardization: regional and local thinking.
Fluency in English language.
At Johnson & Johnson, we want every candidate to feel supported throughout the hiring process. Our goal is to make the experience clear, fair, and respectful of your time.
Here's what you can expect:
Application review: We'll carefully review your CV to see how your skills and experience align with the role.
Getting to know you: If there's a good match, you'll be invited to a short call with one of our recruitment team to understand more about you and answer any questions that you might have.
Staying informed: We know waiting can be hard and processes can evolve; our recruitment team will keep you updated and make sure you know what to expect at each step.
Final steps: For successful candidates, you will need to complete country-specific checks before starting your new role. We will help guide you through these.
Finally, at the end of the process, we'll invite you to share feedback in a short survey -- your input helps us continue improving the experience for future candidates. Thank you for considering a career with Johnson & Johnson. We're excited to learn more about you and wish you the best of luck in the process! #RPOEMEA
#LI-Hybrid
Required Skills: Analytical Thinking, Communication, Decision Making, Microsoft Office, Planning
Preferred Skills: Business Behavior, Compliance Management, Continuous Improvement, Data Analysis, Data Compilation, Detail-Oriented, Execution Focus, Goal Attainment, Internal Controls, Issue Escalation, Process Oriented, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Regulatory Environment, Report Writing

Skills Required