Directeur​/Bestuurder; vervuld

Position: Directeur/Bestuurder (vervuld)
Location: Beerse

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Through our expertise in Innovative Medicine and Med Tech, 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.

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Job Function      Quality
Job Sub Function      Quality Assurance
Job Category      People Leader
All Job Posting Locations      Beerse, Antwerp, Belgium

Job Description      Within Johnson & Johnson Innovative Medicine Supply Chain, we are recruiting a QA Director Commercial Drug Product & Qualified person as member of our Quality management team overseeing Pharmaceutical Drug product manufacturing based in Beerse, Belgium.
J&J Innovative Medicine Supply Chain Beerse serves as Centre of Excellence for the development and manufacturing of Pharmaceutical Drug Products used in treatments that improve the health and lifestyle of people worldwide. The Supply Chain Quality (SCQ) team supports the Beerse site in its mission as Launch & Grow site and is responsible for the quality oversight and final release of Drug Products guaranteeing reliable supplies in compliance with applicable regulations.
As QA Director you lead a team of QA managers and professionals responsible for the quality oversight and timely release of Drug Products manufactured at the commercial facilities of the Beerse site ensuring compliance with applicable regulations. You act as QA Point of Contact ensuring quality oversight of the Drug Product production plants, including sterile manufacturing, device assembly & packaging .

You encourage your team and business partners to continuously strengthen the Quality and Compliance Culture at the site. You act as a leader who provides strategic direction and fosters an environment of innovative thinking.
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. As Qualified Person you keep overall oversight of the global GMP quality systems, enabling compliance with all applicable legislation.
Responsibilities
Lead a team of QA managers and professionals by supporting, coaching and developing team members in reaching quality, business and personal objectives.
As Qualified Person you ensure a continuous evaluation of the GMP quality systems used in the different manufacturing areas operating under the legal entity of Janssen Pharmaceutica NV, Beerse and you are responsible for the certification of each batch of finished commercial product released by Janssen Pharmaceutica, Beerse before being released for commercial use in the EC/EEA or for export.
Establish and maintain strong working relationships with Business Partners in 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 commercial Drug Products ensuring timely release in compliance with global regulations and J&J quality requirements.
Represent Quality in 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 at the site in an effort to continuously strengthen the Quality Culture of the organization.
Apply Quality Risk Management tools in order to proactively detect risks and define mitigation plans by risk‐based decision making balancing…