QA RELEASE RESPONSIBLE SM-API

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 and every 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”! Within Johnson & Johnson, Innovative Medicine Supply Chain, we are recruiting a QA Release Responsible SM-API (M/F/X).
You will be a member of our QA commercial API team overseeing Small Molecule Active Pharmaceutical Ingredients (SM-API) based in Geel, Belgium.
You will be part of an enthusiastic team responsible for the quality oversight of the production plants and timely release of commercial API’s, ensuring compliance with applicable regulations.
Innovative Medicine Supply Chain Geel serves as Centre of Excellence for the development and manufacturing of SM-API’s used in treatments that improve the health and lifestyle of people worldwide.
Innovative Medicine Supply Chain Quality supports the Geel site in its mission as Launch & Grow site.
As a QA Release Responsible SM-API, you are responsible for the quality oversight and timely release of an assigned product portfolio of commercial API’s, ensuring compliance with applicable regulations.
You will also provide quality support to the production plants.
We are looking for a QA Release Responsible who is responsible to.
Establish and maintain strong working relationships with Business and Quality partners to ensure alignment of objectives and results.
Strengthen the quality culture in the supporting departments by providing coaching and/or training on cGMP requirements.
Have Quality oversight of commercial API’s manufactured at the Supply Chain site in Geel.
Work as One team with QA and Supply Chain partners ensuring timely release in support of a reliable supply chain.
Ensure that deviations, CAPAs, Change Controls and Product Quality Complaints are timely and properly investigated by providing quality, compliance and technical expertise such that the internal and external customer expectations are met.
Ensure that deviations and complaints with potential impact on patient safety and/or product supply are properly handled and escalated.
Review and approve Annual Product Review (APR) and Continued Process Verification (CPV) reports for the assigned product portfolio of commercial API’s.
Review and approve GMP documentation such as procedures, work instructions, protocols and reports.
Serve as Subject Matter Expert for assigned Quality Processes.
Act as spokesperson during Health Authority inspections and customer audits.
With focus on Quality activities, develop and foster an environment of innovative thinking through e.
.
benchmarking, training, participating in industry fora.
Continuously challenge the status quo by identifying opportunities for continuous improvement.
Drive the development and implementation of innovative initiatives that deliver sustainable improvement in organizational, quality and compliance performance.
Qualifications Master Scientific degree (chemistry, pharmaceutical sciences, bioengineer, …).
Experience in Chemical and/or Pharmaceutical Supply Chain and/or Quality Assurance and experience as release responsible is an asset.
Demonstrated ability to work independently while staying connected with key stakeholders.
Demonstrated ability to work across organizational boundaries through influencing, negotiation and partnering.
Negotiation, communication and presentation skills across all levels of the organization are important.
Strong analytical thinking skills and able to work in a flexible way under time pressure.
Ability to make risk based decision under time pressure.
Understands the business implications regarding quality positions and decisions.
In-depth knowledge in cGMP (domestic & international), ICH guidelines, policies, standards and procedures.
Experience with Quality Systems.
Experience with regulatory inspections and preparedness.
You speak and write fluent Dutch and English Strong team player Johnson & Johnson is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.