Johnson & Johnson Careers

Senior QMS Associate

High Wycombe, England
Quality Assurance


Job Description

Requisition ID: 1805663472W

Who are Janssen? We’re more than 30,000 people working hard to prevent, treat, cure and stop some of the most devastating and complex diseases of our time. We are committed to issues that touch everyone’s lives. Our mission is to transform individual lives and fundamentally change the way diseases are managed, interpreted, and prevented. We believe that challenging something is the best way to change it.

We are looking future where the world of healthcare will be challenged by informed and empowered patients. We work for change that will improve access to medicines: the best available treatment at an affordable price. That’s why we at Janssen strive to provide access to effective and affordable medicines and related healthcare services to the people who need them.

We have an opening for a Senior Quality Management System Associate to join the QMS team based in High Wycombe, Berkshire. They are a small but united team who are looking for a colleague who is open to new ideas, friendly and communicative. There are opportunities to develop yourself for progression within the department as well as within the organisation.


ROLE PURPOSE
The Senior QMS Associate is responsible for supporting the development and maintenance of the QM System for Janssen UK and Ireland and for ensuring an inspection-ready culture. You will also be responsible for compliance with the elements of the Johnson & Johnson QP and J&J QMS activities for the LOC / Cluster undertakes. This position is also responsible for the continuous improvement of the QMS status of the LOC/Cluster.


KEY RESPONSIBILITIES
You will implement, maintain and monitor the quality system for commercial organisations including:

- Executing lifecycle management of GMP. GDP documents and records to ensure regulatory compliance and business continuity.

- Providing appropriate training for all relevant regulated functions.

- Supporting external inspections through co-ordinating and preparing document systems and evidence.

- Managing the perpetration, execution and follow up of internal and external Quality issued and CAPA’s related to GxP

- Monitoring quality systems performance versus Local GxP and company metric requirements.

- Providing input to the Quality Head for the bi-annual Quality System Management Review for the LOC/Cluster.

- Populating metric data in the slide deck. Managing the QSMR minutes and certification.

- Notifying and engaging LOC Quality Head and other affected partners with any substantive quality or compliance concerns.

- Maintaining the business Quality Manual

- Produce risk based annual internal and supplier audit schedules. Lead for approving audit plans. Conduct internal audits as required by the schedule.


QUALITY PROCESSES YOU WILL HAVE RESPONSIBILITY FOR:
- Managing local procedural documents to ensure revision and update, ensuring that training is provided and completed by relevant parties.

- Procedures management system (TruVAULT) Admin - you will be the point of contact/SME for the UK LOC.

- Conducting regular (self-)inspections of GxP practices for supply chain within the responsibilities of the Local Operating Company.

- You will collaborate effectively with partners, such as the LSO, the commercial department, other Cluster/LOC in EMEA and any other functions.

- Ensuring you qualify and audit GxP suppliers in the LOC/Cluster against company & local GxP standards.

- Specific responsibility for approval of low risk suppliers. Maintenance of ASL and internal ASL. Perform supplier audits.


Qualifications

Do you feel this is a good fit? to successful in this role you will the following Skills, experience and Educational background:

- Do you have good verbal and written interpersonal skills ?

- Are you experienced in Advanced Excel functionality (including Formatting, Pivot tables, working with large data sets and being able to present data)?

- Have you got experience with Quality Systems or have meaningful experience including Quality Compliance.

- Direct experience of general quality requirements and guidelines/legislation.

- Expert knowledge of Quality database systems

- Ability to negotiate and communicate with partners

- At least 2 years’ experience in the Pharmaceutical or related industry

- Up to date knowledge of relevant pharmaceutical legislation and GMP/GDP

- Knowledge and full understanding of Quality Policy and Standards, the Cluster/LOC QMS

- Standout colleague within region, ability to demonstrate across LOC’s in EMEA/WW

Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applications will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.


Primary Location
United Kingdom-England-High Wycombe
Organization
Janssen Cilag Ltd. (7360)
Job Function
Quality Assurance
Requisition ID
1805663472W