Quality Senior Specialist - Process & Operations

Quality Senior Specialist - Process & Operations

• Location: Beerse

• Duration of the contract: Until September 30, 2027

• Hours per week: 40 | Contract: Fixed-term Employee Payroll only (No B2B / No Freelancers)

Imagine your next project shaping the quality processes that oversee external suppliers, ensuring safety and compliance on a global scale. As a Quality Senior Specialist - Process & Operations, you will play a critical role in developing and deploying Quality Management Systems and managing quality oversight of external partners throughout their lifecycle.

roles and responsibilities

In this role, you will be supporting base business processes and improvement projects within EQ.

This will involve:

• Perform related duties as assigned by J&J Sponsor.

• Maintain compliance with all company policies and procedures.

• Own processes and/or support the End to End EQ Process owners.

• QMS and process development/Deployment.

• Assessment and update of EQ Procedures to optimally manage the Quality oversight of external suppliers throughout their lifecycle.

• Manage and Lead/ Support Quality Systems assigned – both External Quality Systems and Global Quality systems for EQ.

• Continuous monitoring and improvement of current EQ processes and systems by:

  • Obtaining and Integrating current best industrial quality practices.

  • Ensuring EQ Quality Processes are lean and agile catering for all classes of suppliers, throughout their lifecycles.

  • Aligning EQ procedures with harmonized enterprise procedures.

  • Using Regulatory intelligence to ensure that EQ business, quality and compliance goal adhere to J&J, JSC and government-issued environmental, health, safety, quality and regulatory policies.

  • Remaining current with regulations, guidelines and quality practices associated with the pharmaceutical industry.

• Responsible for supporting base business processes and business improvement projects within EQ.

• Propose and participate in solutions for existing EQ processes and system constraints.

• Represent and collaborate on introduction of strategic or new operating processes / systems.

• Support strategic process development initiatives and project management activities.

• Support the Processes & Operations group on key base business improvement projects.

• Ensure trainings are executed timely.

how to succeed

To be successful, you should have a solid foundation in pharmaceutical quality operations and external manufacturing.

You will also bring:

• Minimally basic degree in Science, Engineering and Technical subjects.

• Process wide range experience with at least 5 years in the pharmaceutical industry.

• Working knowledge of working with external manufacturers and supplier partners.

• Knowledge in cGMP, policies and procedures.

• Excellent analytical skill to identify gaps and root causes of issues and think out of the box to develop a solution.

• Must be able to work independently with minimum supervision to meet tight deadlines and maintain a positive attitude.

• Excellent verbal and written communication skills, including ability to effectively communicate with internal and external customers.

• Excellent computer proficiency e.g MS Office, SAP.

• Demonstrated knowledge of the business environment inside a quality organization, across various roles (e.g., quality operations, QC, Quality Systems, pre-production quality assurance, validation, regulatory, operations, NPI etc.).

• Demonstrated knowledge of applicable regulations globally.

• Ability to build relationships and confidence with External Manufacturers/Suppliers who support J&J.

benefits

This role offers a very competitive hourly rate. This contract will run until September 30, 2027.

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”.