Pilot Plant Quality and Compliance Lead (Sr. Manager)

The Chemical Process Research and Development (CPRD) department is seeking a Pilot Plant Quality and Compliance Lead (Sr manager level) to join our team in Belgium. CPRD has three state of the art chemical pilot plants in Beerse and Geel which support the development of new chemical processes and produce Active Pharmaceutical Ingredients (API’s) used in clinical trials. The Chemical Development Pilot Plant (CDPP) in Geel also supports the launch of new small volume commercial products. The pilot plants are constantly innovating their technology- and data infrastructure to accommodate for future products and they operate according to phase appropriate cGMP’s . As an expert the Quality and Compliance lead is responsible for the implementation of the phase appropriate quality& compliance standards in the pilot plants with a focus on work-processes, process-equipment, computer systems, data integrity and building &facilities.

As member of the pilot plant staff, the lead works closely together with the Quality Assurance Organization and the site systems owners network to be sure the pilot plants are inspection ready. For this purpose the Quality and Compliance Lead organizes risk-assessments, gap-analyses and live cycle management to be sure an adequate quality system is set up for clinical supply. In the environment of constantly evolving regulatory requirements, the pilot plant quality and compliance lead is also responsible to define a risk based approach consistent with the current stage of drug development and product knowledge.

• Ph. D. or Master in Chemistry or Chemical Engineering, with 5-10 years of experience in the Pharmaceutical Industry.
  
• Practical knowledge of cGMP and Q7A.
  
• Strong team player with previous experience in leading teams.
  
• Understanding of process safety, operations, process development & engineering
  
• Hands-on experience in pilot or large-scale manufacturing plants
  
• Challenge the status quo and analytical mindset
  
• Project management skills

Defines what phase appropriate c-GMP’s means for the API pilot plants in an evolving landscape and how CDS can implement these requirements retaining the flexibility and speed for development activities.
Initiating and implementation of projects to keep the compliance level of CDS systems at the evolving and required standards. Systems in scope are equipment and systems qualification, data integrity, contamination control, system based compliance, … .
Function is the spokesperson towards the QA organization and takes the lead in CDS to prepare audit readiness of the plant.
Function has to install a live cycle management program to keep our systems in accordance with the actual regulations.
Is SME in GMP requirements for API production and gives guidance to the team

Defines what phase appropriate c-GMP’s means for the API pilot plants in an evolving landscape and how CDS can implement these requirements retaining the flexibility and speed for development activities.
Initiating and implementation of projects to keep the compliance level of CDS systems at the evolving and required standards. Systems in scope are equipment and systems qualification, data integrity, contamination control, system based compliance, … .
Function is the spokesperson towards the QA organization and takes the lead in CDS to prepare audit readiness of the plant.
Function has to install a live cycle management program to keep our systems in accordance with the actual regulations.
Is SME in GMP requirements for API production and gives guidance to the team

Beerse/ BE

Beerse/ BE