Sr QA Associate Clinical Supply Quality

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

Job Function:

Quality

Job Sub Function:

Quality Assurance

Job Category:

Professional

All Job Posting Locations:

Beerse, Antwerp, Belgium

Job Description:

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

Within Johnson & Johnson Innovative Medicine, we are recruiting a Senior QA Associate in Clinical Supply Quality (CSQ), part of Product Quality Management (PQM).

CSQ is responsible for the end-to-end Quality & Compliance oversight for the internal and external clinical supply leading up to the release and certification of Investigational Medicinal Products used in clinical trials. We are continuously adapting and improving our quality processes to provide hope in a box for our patients.

As a member of CSQ you play a key role in guaranteeing product safety, compliance with regulations and data reliability.

In this pivotal role, you will lead the clinical release of Investigational Medicinal Products (IMPs). The product portfolio includes synthetics, proteins as well as cell and gene therapy products, manufactured by our J&J pilot plants, J&J commercial sites and by our network of External Manufacturers.

You will be at the heart of a collaborative network, working closely with colleagues in CSQ, Therapeutics Development and Supply (TDS), External Clinical Supply Quality (ECSQ) and our J&J (pilot) plants in Beerse, Latina, Leiden and Schaffhausen manufacturing clinical trial material.

Are you passionate about ensuring the highest standards of quality in clinical development? Join our dynamic team in Beerse as a Senior QA Associate. Your expertise will directly impact patient safety, regulatory compliance and data reliability.

Key Responsibilities:

• Build strong cross-functional partnerships with Quality and Therapeutics Development and Supply partners to ensure timely release and certification of clinical trial material.
• Act as Process Owner for the end-2-end clinical drug product release process.
• Set and drive priorities based on Clinical Trial timelines, while addressing potential roadblocks.
• Ensure all parties involved in release work in sync to set timelines.
• Ensure timely review of records such as master data, batch record and confirmation of clinical trial material in support of the clinical release process.
• Ensure that deviations are timely and properly investigated and adequate CAPA's are defined for investigations with potential product quality impact. Ensure in-depth investigations by providing technical, quality and compliance expertise.
• Act as spokesperson during Health Authority inspections and customer audits.
• Continuously challenge the status quo and support the development and implementation of breakthrough innovative initiatives that deliver sustainable improvement in organizational, quality and compliance performance.

Job Qualifications:

• University degree, scientific orientation (pharmaceutical, chemical, or biological sciences).
• At least 3 years of cross-functional experience in the pharmaceutical industry.
• Experience in pharmaceutical supply chain and/or Quality Assurance is an asset.
• Demonstrated ability to work independently while staying connected with key stakeholders.
• Operational Quality and/or Production related expertise is an asset.
• Product development expertise is an asset.
• Ability to prioritize, quickly assimilate new technologies and product knowledge, perform risk assessment and develop action plans.
• In-depth knowledge in cGMP (domestic & international), ICH guidelines, policies, standards and procedures.
• Understands the business implications regarding quality positions and decisions.