Quality Management Systems (QMS) Associate

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

Job Description:

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 https://www.jnj.com/innovative-medicine

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 Inte...