QA Specialist Serialization And Automation

QA Specialist Serialization And Automation

Location: EMEA (Must live close to a J&J Manufacturing site, such as Beerse or Geel in Belgium, Leiden in the Netherlands, Schaffhausen in Switzerland, Latina in Italy, or Cork in Ireland)

Duration of the contract: 1 year 

Hours per week: 32 to 40 (Hybrid)

Imagine your next project shaping global quality standards for serialization and automation across an industry-leading network. We are seeking an experienced QA Specialist to act as the global Quality Representative on two critical cross-functional programs: upgrading existing serialization systems and implementing a new Manufacturing Digital Connect layer. In this role, you will lead the global alignment of quality procedures and ensure seamless compliance with worldwide health-authority requirements.

roles and responsibilities 

You will serve as the primary QA point of contact and lead the development of consolidated global procedures.

This will involve: 

• Serve as the Global Quality SME on these program teams — act as the primary QA point of contact for regulatory and compliance matters. 

• Lead development of one consolidated Global Serialization SOP suite (procedures and work instructions) that supersede local site documents for serialization. 

• Translate regulatory requirements into site‑level quality requirements and procedural controls; ensure SOP alignment. 

• Lead training and competency activities for QA and operations staff on global procedures. 

• Understanding the quality impact of the new Manufacturing Digital Connect integration layer and defining global Quality requirements.

how to succeed 

To be successful in this role, you should have a strong background in Quality within pharmaceutical/biotech manufacturing, specifically focusing on serialization, track-and-trace, and global GxP SOP authoring.

You will also bring: 

• Medior to Senior level experience in Quality or Serialization within pharmaceutical/biotech manufacturing

• Demonstrable experience with serialization and/or track-and-trace like projects at a global scale. 

• Hands‑on experience writing and implementing global GxP SOPs. 

• Practical familiarity with the EU Falsified Medicines Directive (EMVS/EMVO model), US DSCSA operational requirements, or China NMPA traceability expectations (or demonstrable experience with national repository models). 

• Strong SOP authoring, change control and risk assessment skills. 

• Technical understanding of serialization. 

• Bachelor's degree in Pharmacy, Life Sciences, Engineering or comparable. 

• • Technical understanding of manufacturing automation, and Data Integrity. • Excellent stakeholder management and influencing skills: experience working with Global Quality, IT/Digital, Regulatory Affairs, Operations and commercial/MAH stakeholders. • Advanced degree preferred.

Benefits

This role offers a very competitive hourly rate. This contract will run for 1 year.

you are welcome here 

Johnson & Johnson is 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.

about Johnson & Johnson 

Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 130 years. As a skilled contractor, you’ll play a key part in the thinking, strategy, dynamism - and impact - of this iconic global healthcare company as they touch the lives of nearly a billion people every day. Contribute to the next healthcare breakthrough with your next project at Johnson & Johnson.

application process 

We are looking to process the first round of applications within the next 2 working days. We do not accept applications via email.

Diversity, Equity & Inclusion 

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 are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each 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”.