Manager Qc Npi Geel

il y a 1 semaine

Antwerpen, Flandre, Belgique Johnson & Johnson Temps plein
Join
Janssen Supply Chain, part of the
Johnson & Johnson Family of Companies


We're actively looking for a skilled and enthusiastic
QC New Product Introduction (NPI) Lead (M/F/X) to join our dynamic Quality team, overseeing Small Molecule Active Pharmaceutical Ingredients (SM-API) and Drug Product (DP) Intermediates in
Geel, Belgium .


Janssen 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 lifestyles of people worldwide.

Janssen Supply Chain Quality (JSCQ) supports the Geel site in its mission as Launch & Grow site and is responsible for the quality oversight, In-Process-Control (IPC), release testing and release of SM-API and DP Intermediates guaranteeing reliable supplies in compliance with applicable regulations.


As QC NPI Lead, you lead a team of NPI analysts and analytical owners responsible for the transfer, optimization, and validation of analytical methods for new products. You partner with R&D and/or commercial Supply Chain in support of the commercialization of new SM-API and DP Intermediates. You provide overall leadership and direction to the QC NPI organization, building processes to continuously strengthen the capabilities and performance of the department. You act as a leader who enables creative thinking and provides technical leadership to introduce innovative medicines at the Geel site.
The QC NPI Lead, reporting to the Head QC Geel, acts as a people leader.

Main responsibilities include:

  • Lead and support a team of analytical experts (NPI analysts and analytical owners) to achieve business and personal objectives through coaching and people development.
  • Develop strategies and standards applicable to the laboratory environment to ensure new product launch objectives are met.
  • Identify trends and take actions for continuous improvement in team, method, product performancee.
  • Develop and deploy analytical innovations in collaboration with R&D, influencing them to meet our operational requirements for bestinclass methods and technologies.
  • Represent QC in NPI review meetings and actively engage in scientific meetings and stage gate reviews. Contribute to these meetings by sharing information, knowledge, ideas, and judgement to support site and team goals.
  • Establish partnership and engagement with QC Operations (IPC and release labs) to ensure alignment of planning, workflows, instrument utilization and material supply by clear and proactive communication.
  • Ensure that adequate resources are available and effective to accomplish tasks and deliver results. Ensure availability of adequate materials and timely readiness of new technologies. Recommend and justify the purchase of materials and analytical instruments together with QC support group and QC leadership team.
  • Ensure accurate recording of information in NPI projects, adeptly managing quality records (raw data, investigations, CAPAs, Change Controls, protocols, and reports) to meet both internal and external customer expectations.
  • Adhere to established operating procedures, safety regulations, and company work standards. Write or review and approve work instructions and procedures for QC NPI activities.
  • Remain current in knowledge and skills towards analytical technologies and industry trends.
  • Ensure inspection readiness and act as spokesperson during audits and inspections.

Qualifications:

Job Qualifications:

  • Master Scientific degree (chemistry, pharmaceutical sciences, engineer,) with 3 to 5 years of experience in pharmaceutical product development and/or release testing, or equivalent experience performing progressively advanced duties beyond a Bachelor of Science degree.
  • People leadership skills, preferably with experience leading teams in R&D or Quality.
  • Indepth knowledge of a laboratory environment with a sound technical knowledge of analytical techniques and knowledge of related laboratory instruments.
  • Proven scientific leader who enables creative thinking and drives implementation of concepts into practical business needs balancing pragmatism within a GMP framework.
  • Ability to quickly assimilate new analytical technologies, perform risk assessments and develop action plans.
  • Demonstrated ability to collaborate across organizational boundaries through influencing, negotiation, and partnering, with essential skills in communication and presentation across all levels of the organization.
  • Comprehensive understanding of cGMP (domestic & international) and ICH guidelines.
  • Strong analytical thinking skills and able to work in a flexible way under time pressure. Ability to make riskbased decision under time pressure.
  • Demonstrated ability to work independently in a dynamic environment, adeptly manage multiple tasks, and collaborate effectively with key stakeholders.
  • Strong interpersonal and teamwork skills.
  • Fluency in Dutch and English languages.

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