Senior Manager Commercial Quality UK

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:
Quality Assurance

Job Category:
People Leader

All Job Posting Locations:
High Wycombe, Buckinghamshire, United Kingdom

Job Description:

J&J Innovative Medicine is recruiting for a Senior Commercial Quality Manager UK to be located in UK.

JOB PURPOSE

The position serves as cluster lead of quality and compliance and oversees the Market Authorisation Holder requirements for licensed products in the UK and Ireland. 

The Senior Commercial Quality Manager UK is responsible for the implementation and maintenance of a Quality Management System for pre and post marketing regulated activities and ensures in collaboration with the various leads of regulated functions (e.g.

local safety officer (PV), Head of Regulatory, Medical affairs, etc) that the implementation meets the requirements of J&J Quality Policy and that all applicable and global, regional and local regulations are met.

The Commercial Quality Head UK maintains the Business Quality processes and systems to ensure the daily availability of high-quality products and services in the UK and Ireland markets.

ORGANISATION INTERFACES

All functions within J&J Innovative Medicine UK, Ireland and J&J IM EMEA including commercial partners, local safety officer (PV), Head of Regulatory, Medical Information, J&J IM supply Chain, CLS, compliance organizations including JJRC and RDQ, Pharm Global CQ, Cross sector CQ and J&J Corporate Entities.

The Senior Commercial Quality Manager UK interfaces with external Health Authorities including but not limited to MHRA, HPRA, and the UK Home Office.  Other external interfaces include 3PL and suppliers.

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MAIN DUTIES & RESPONSIBILITIES



* Develop and drive improvement in the Quality System supporting the UK and Ireland operating companies specifically Quality System Management Review, CAPA, Internal Audit, Escalation, Trending, Risk Management, Quality Planning and Failure Investigation.


* QSMR Lead providing in-depth data analysis of product information including complaint data and prepares and delivers, the Quality System Management Reviews (QSMR) for all the LOCs under scope.


* Serve as LOC lead on de-risking programs gathering appropriate input to ensure commercial business risks are being addressed and mitigated.


* Carry out strategic planning and development process on a continuous...