Senior QA Associate – Quality Systems

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

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Job Description:

Within J&J Innovative Medicine Supply Chain, a member of Johnson & Johnson's Family of Companies, we are recruiting a Senior QA Associate – Quality Systems (M/F/X).

As a member of our Quality team overseeing the Quality Systems (QS) processes, you will be based in Geel, Belgium.

J&J Innovative Medicine Supply Chain Geel serves as Center of Excellence for the development and manufacturing of Small Molecule API (SM-API) and DP Intermediates used in treatments that improve the health and lifestyle of people worldwide. J&J Innovative Medicine Supply Chain Quality supports the Geel site in its mission as Launch & Grow site and is responsible for the quality oversight and final release of SM-API and DP Intermediates, guaranteeing reliable supplies in compliance with applicable regulations.

As Senior QA Associate – Quality Systems, you are Subject Matter Expert of Quality System processes such as document management, records management. You drive the implementation at the Geel site and ensure adherence to the Quality System. In this role you report directly to the Senior QA Manager.

In this role you are responsible to:

• Establish and maintain strong working relationships with your global Quality Systems partners as well as your local Quality and Supply Chain colleagues

• Act as QA Point of Contact for the Geel site ensuring Quality Systems are appropriately implemented and applied in compliance with global regulations and J&J quality requirements

• Coach cross-functional teams at the site, including Quality professionals

• Act as Local Process Owner for Quality System processes such as document management, records management,… by:

  • Acting as local Subject Matter Expert, ensuring GMP documentation is in place and training provided in compliance with global regulations and J&J quality requirements

  • Providing support to local users and QA approvers

  • Driving the site to continuously strengthen related skill sets across the entire organization

  • Evaluating trends and defining appropriate actions

  • Defining, following up and concluding corrective and preventive actions related to the Quality System processes

• Ensure that quality records such as change controls, non-conformances and CAPAs are handled properly and in a timely manner by providing quality, compliance and technical expertise so that the internal and external customer expectations are met

• With focus on Quality Systems processes, develop and foster an environment of innovative thinking through e.g. benchmarking and training. Continuously challenge the status quo by identifying opportunities for continuous improvement

• Lead and participate in continuous improvement initiatives on the Quality System processes

• Act as spokesperson during Health Authority inspections and customer audits

Qualifications:

• Master Scientific degree with a technical specialization in analytics / chemistry / biotechnology / pharmaceutical sciences (or equivalent through experience)

• In-depth knowledge of cGMP (domestic & international), ICH guidelines, policies, standards and procedures

• Experience in Chemical and/or Pharmaceutical Quality Control and/or Quality Assurance

• Experience with Data Analysis and continuous improvement methodologies is an asset

• Experience in people leadership is an asset

• You work accurately and proactively seek solutions

• You have good communication skills

• You speak and write Dutch and English fluently

• Strong analytical thinking skills and the ability to work in a flexible way under time pressure in local and global teams. Ability to make risk based decisions under time pressure. Understands the business implications regarding quality positions and decisions.