Sr Quality & Compliance Operations Specialist

At Johnson & Johnson,we believe health is everything.

Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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 jnj.com .

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world.

We provide an inclusive work environment where each person is considered as an individual.

At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:
Supply Chain Engineering

Job Sub Function:
Quality Engineering

Job Category:
Scientific/Technology

All Job Posting Locations:
Geel, Antwerp, Belgium

Job Description:

Geel Site | Johnson & Johnson Innovative Medicine

Do you want to play a key role in protecting product quality and patient safety?

We are looking for a Contamination Control Program Owner (CCP Owner) who will take the lead in further developing and maintaining our site-wide strategy for the prevention of microbiological contamination.

As CCP Owner, you are the central point of contact for the contamination control strategy at the Geel site.

You work with the various departments and Site Leadership to ensure a robust, scientifically sound and future-oriented contamination control program.

Your responsibilities


* Ownership of the Geel CCP.


* Leading contamination risk assessments and CCP reviews:
+ Defining contamination control measures and critical control points.
+ Evaluating residual risks and opportunities for improvement.
+ Ensuring consistent application of Quality Risk Management within the CCP.


* Evaluating trends and state-of-control indicators.


* Providing impact analysis for the introduction of new products and for facility, utility and process changes.


* Driving continuous improvement initiatives based on innovations and best practices.


* Representing the site within global CCP-related networks.


* Supporting inspections, audits and management reviews.


* Ensuring periodic reviews and lifecycle management of the CCP.


* Participating in Change Control Boards and relevant governance forums.

Your profile


* Strong scientific and technical background.


* Experience in GMP-environments.


* Demonstrated experience and knowledge of microbiological contamination control, cleanroom management, Annex 1 and Quality Risk Management.


* Strong stakeholder management and communication skills.


* Strong project management skills.


* Ability to think strategically and deliver operational impact.

Required Skills:

Preferred Skills:
AI Judgement Integration, Coach...