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 https://www.jnj.com
Job Function: Quality
Job Sub Function: Quality Assurance
Job Category: People Leader
All Job Posting Locations: Geel, Antwerp, Belgium
Job Description:
Within Johnson & Johnson Innovative Medicine Supply Chain, we are recruiting a QA Director Commercial API (M/F/X) as a member of our Quality team overseeing Small Molecule Active Pharmaceutical Ingredients (SM-API) based in Geel, Belgium.
J&J Innovative Medicine Supply Chain Geel serves as a Centre of Excellence for the development and manufacturing of SM-API 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, 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 APIs manufactured at the commercial Launch & Grow facilities of the Geel site, ensuring compliance with applicable regulations. You act as QA Point of Contact ensuring quality oversight of the API production plants. 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 GMP activities such as manufacturing, packaging, labelling, testing, release, storage, importation, and distribution are carried out as required by legislation.
Job Responsibilities:
* Lead a team of QA managers and professionals by supporting, coaching, and developing team members to reach quality, business, and personal objectives.
* 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 supporting departments by providing coaching and/or training on cGMP requirements.
* Act as QA Point of Contact for commercial API, ensuring timely release in compliance with global regulations and J&J quality requirements.
* Represent Quality in review meetings governing Quality and Compliance metrics and operational business performance of the Quality Unit. Identify trends and define actions to ensure continuous improvement of Quality and Compliance performance at the site, strengthening the Quality Culture.
* Apply Quality Risk Management tools to proactively detect risks and define mitigation plans by risk-based decision making, balancing business implications with Quality and Compliance requirements. Properly escalate risks impacting patient safety and/or product supply.
* Provide strategic direction and foster innovative thinking through benchmarking, training, and industry participation. Continuously challenge the status quo by finding opportunities for improvement. Drive the development and implementation of innovative initiatives for sustainable organizational, quality, and compliance performance improvements.
* Review and approve procedures and work instructions.
* Ensure quality records such as investigations, CAPAs, Change Controls are handled timely and properly, meeting internal and external customer expectations.
* Ensure deviations impacting patient safety and/or product supply are properly escalated.
* Stay current with regulatory and industry trends.
* Act as spokesperson during Health Authority inspections and customer audits.
Job Qualifications:
* Master's degree in sciences such as chemistry, pharmaceutical sciences, bioengineering, etc.
* At least 10 years’ experience in Chemical and/or Pharmaceutical Supply Chain and/or Quality.
* Proven ability to provide strategic leadership in a dynamic environment.
* Ability to work independently and collaboratively with stakeholders.
* Strong influencing, negotiation, and communication skills across organizational levels.
* People leadership experience, especially in Supply Chain or Quality teams.
* Proven innovation leadership, enabling creative thinking and pragmatic implementation within GMP frameworks.
* Strong analytical skills, able to work under time pressure and make risk-based decisions.
* Ability to quickly learn new modalities and technologies, perform risk assessments, and develop action plans.
* Deep knowledge of GMP (domestic & international), ICH guidelines, policies, standards, and procedures.
* Experience with regulatory inspections and preparedness.
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