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J&J MedTech Sweden - Manager Quality Assurance/Quality Systems - 2406166645W

Description

MedTech - Surgical Vision Uppsala (site)

With an eye for better vision

Johnson & Johnson Vision develops and manufactures optical products and solutions that make a difference to human vision worldwide. We offer market-leading technology for laser surgery, equipment for cataract surgery and intraocular lenses.

In Uppsala, we manufacture Healon, a market-leading product used during eye surgery. Upon its launch in 1980, Healon paved the way for safe and quick eye surgery, whereby a patient’s cataracts can be replaced with new lenses in just a few minutes.

With over 130,000 employees, Johnson & Johnson is one of the world's largest and leading pharmaceutical and healthcare companies.

Within J&J Vision – a part of the Johnson & Johnson MedTech business area - we are nearly 10 000 employees represented in 103 countries, of which approximately 130 employees work at our site in Uppsala.

Read more at www.jjvision.com

Introduction

The roll of Manager Quality Assurance / Quality Systems leads a team with seven direct reports and is managing the JJSV Uppsala Quality Assurance, Validation and Quality Systems.

This position reports directly to the Quality Director at JJSV, Uppsala and is a highly valued member and key contributor in the site Quality Management Team. In this position you work with both operative and strategic tasks.

Take the opportunity to work at a smaller site in a Big Pharma context. We have a highly competent and engaged international quality community which is integrated in the local quality unit and operational activities.

Job Position Summary

• Leading a team of specialists within QA / QS Release, Validation, Document- and Labelling Management, Change Control and Quality support systems.

• Responsible for quality assurance of product, raw materials/input materials, media, and manufacturing processes.

• Process Owner for the Release Process, Validation Process, Document, Change Control process, Labeling Process and Training process.

• Operational planning, resource planning and assure that KPIs are carried out within QA Uppsala.

• Ensure that responsibilities and authority and working methods within Quality Assurance department are regulated by written procedures that comply with applicable regulations.

• Operate in accordance with applicable regulations and standards, as well as GMP requirements for the markets where AMO Uppsala's products are marketed.

Duties & Responsibilities

• Lead and develop the business to fulfill the quality department goals in line with site goals

• Resource and cost dimensioning QA/QS Quality Assurance/Quality System

• Responsible for ensuring QA / QS Release, Validation, Document- and Change Control, Labelling Management, and Quality Support Systems.

• Member of the Quality Management Team

• Delegated responsibilities on behalf of Q Director

Qualifications

• Academic education with a microbiological, pharmaceutical, scientific or technical orientation.

• Minimum 3 – 5 years relevant work experience in the pharmaceutical industry / Medical Device or other process industry (GMP or ISO13485).

• Relevant leadership experience for the position.

• Experience in project management.

• Experience with previous work on Good GMP/ISO knowledge, as well as knowledge of regulations and guidance (e.g. CFR, pharmacopoeias).

• Good oral and written proficiency in both Swedish and English.

The position is located at AMO Uppsala site in Uppsala, Sweden

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.

We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences.

That is why we in Nordics are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.

Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”!

Application

If you are interested in this position we look forward to your application, kindly apply with an updated CV and Cover letter. The selection process will start during the posting period, please send in your application as soon as possible. We reserve the rights to close the advert earlier. All applicants can expect feedback on the application.

If you have issues applying, please use Chrome Web Browser and reset your password. If that does not help you can get more guidance and contact us from this page: https://www.careers.jnj.com/contactus-faq

Primary Location Europe/Middle East/Africa-Sweden-Uppsala-Uppsala

Organization AMO Uppsala AB (8507)

Job Function Quality Assurance

Req ID: 2406166645W