QA Director Commercial API

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

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Job Description:

Within Johnson & Johnson Innovative Medicine Supply Chain, we are recruiting a QA Director Commercial API (M/F/X) as 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 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 API’s 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 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 QA managers and 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 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 API 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 business implications with Quality and Compliance requirements. Ensure that risks with potential impact on patient safety and/or product supply are properly escalated.

• With focus on Quality activities, provide strategic direction and foster an environment of innovative thinking through e.g. 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.

• Remain current in knowledge and skills towards regulatory and industry trends.

• Act as spokesperson during Health Authority inspections and customer audits.

Job Qualifications:

• Master Scientific degree (chemistry, pharmaceutical sciences, bioengineer, …).

• At least 10 years’ experience in Chemical and/or Pharmaceutical Supply Chain and/or Quality.

• Ability to provide strategic leadership to meet business objectives in a highly dynamic business environment.

• 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.

• People leadership skills, experienced team leader for Supply Chain or Quality team.

• Proven Innovation Leader who enables creative thinking and drives implementation balancing pragmatism within a GMP framework.

• Strong analytical thinking skills and able to work in a flexible way under time pressure. Ability to make risk-based decisions under time pressure. Understands the business implications regarding quality positions and decisions.

• 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.