SENIOR MANAGER QA

Within Johnson & Johnson Innovative Medicine Supply Chain, we are recruiting a Senior QA Manager New Products (M/F/X) as member of our Quality team overseeing Small Molecule Active Pharmaceutical Ingredients (SM-API) and Drug Product Intermediates (DP Intermediates) based in Geel, Belgium.
J&J Innovative Medicine Supply Chain Geel serves as Centre of Excellence for the development and manufacturing of SM-API and DP Intermediates used in treatments that improve the health and lifestyle of people worldwide.
The Supply Chain Quality (SCQ) team supports the Geel site in its mission as Launch & Grow site and is responsible for the quality oversight and final release of SM-API and DP Intermediates guaranteeing reliable clinical and commercial supplies in compliance with applicable regulations.
As Senior QA Manager New Products, you lead a team of QA professionals responsible for the quality oversight and release of clinical API’s manufactured at the R&D plants in Geel and Beerse as well as the introduction of API’s into the commercial Launch & Grow facilities of the Geel site ensuring timely readiness for commercial launch.
You also lead a team of QP Site Delegates responsible for quality oversight and release of DP Intermediates for worldwide clinical and commercial use in close collaboration with the clinical and commercial QP’s of Janssen Pharmaceutica NV.
Under your leadership, you ensure that the GMP activities as manufacturing, packaging, labelling, testing, release, storage, importation and distribution are carried out as required by legislation.
Job Description.
Lead a team of Quality professionals by supporting, coaching and developing team members in reaching quality, business and personal objectives.
Establish and maintain strong working relationships with Business Partners in R&D and commercial Supply Chain as well as local and global 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.
Act as QA Point of Contact for New Products ensuring timely release in compliance with global regulations and J&J quality requirements within a phase appropriate framework.
Represent Quality in product development and launch readiness meetings governing proactive Quality and Compliance.
Support the QP Site Delegates in their role as site representative of the clinical and commercial QP’s of Janssen Pharmaceutica NV ensuring release and QP oversight.
Apply Quality Risk Management tools in order to proactively detect risks and define mitigation plans by risk based decision making balancing business implications with Quality and Compliance requirements.
Ensure that risks with potential impact on patient safety, product supply and/or launch are properly escalated.
With focus on Quality activities, develop and foster an environment of innovative thinking through e.
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benchmarking, training, participating in industry fora.
Continuously challenge the status quo by finding opportunities for continuous improvement.
Drive the development and implementation of innovative initiatives that deliver sustainable improvement in organizational, quality and compliance performance.
Review and approve procedures and work instructions.
Ensure that quality records such as investigations, CAPAs, Change Controls are timely and properly handled by providing quality, compliance and technical expertise such that the internal and external customer expectations are met.
Ensure that deviations with potential impact on patient safety and/or product supply are properly escalated.
Support Quality review meetings governing Quality and Compliance metric and operational business performance of the Quality Unit.
Identify trends and define actions ensuring continuous improvement of the Quality and Compliance performance of the site in an effort to continuously strengthen the Quality Culture of the organization.
Remain current in knowledge and skills towards regulatory and industry trends.
Act as spokesperson during Health Authority inspections and customer audits.
Qualifications · Master Scientific degree (chemistry, pharmaceutical sciences, bioengineer).
Industrial Pharmacist/ EU certified Qualified Person is asset.
· At least 10 years’ experience in Chemical and/or Pharmaceutical R&D, Supply Chain and/or Quality.
Experience with product development from Early Development over Late Development until commercialization is an asset.
· People leadership skills, preferably experienced team leader for R&D, Supply Chain or Quality team.
· Demonstrated ability to work independently while staying connected with key stakeholders.
· Proven track record to work across organizational boundaries through influencing, negotiation and partnering.
Negotiation, communication and presentation skills across all levels of the organization are important.
· Ability to provide strategic leadership to meet business objectives and a highly dynamic business environment.
· Proven Innovation Leader who enables creative thinking and drives implementation of R&D knowledge into commercial supply chain balancing pragmatism within a GMP framework.
· Ability to quickly assimilate new modalities and technologies, perform risk assessments and develop action plans.
· In-depth knowledge in GMP (domestic & international), ICH guidelines, policies, standards and procedures.
· Experience with regulatory inspections and preparedness.
· 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.
Johnson & Johnson is an equal opportunity employer, 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.