Process Manager (Quality)

Location: Netherlands

SIRE Life Sciences® is the market leader in life science recruitment. We believe the recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!

THE COMPANY

Our client is a professional Pharmaceutical organization, based in Zuid-Holland Netherlands.

This company discovers, develops and produces new innovative human therapeutics that improve the life expectancy of humanity.

ROLE DESCRIPTION

As the process manager you are accountable for a larger section of the procedural framework and responsible for ensuring that GxP and similar requirements are adequately described. You have content knowledge of the area you will work with partners from the business and other quality functions to ensure the process meets their requirements and aligns with their operations including the training development and roll-out.

The Business Process Manager (BPM) will contribute to the development of a quality system that enables theOrganization to conduct clinical trials in an efficient and compliant way, resulting in clinical programs that allow for seamless registration of the compounds.

RESPONSIBILITIES

- You will oversee detailed process development, procedural document development, training development in collaboration with the responsible functions to ensure content and requirements of the design are fully transferred and implemented. Collaborate with responsible leaders to ensure planning is met, providing input to the functions in a matrix.
- You will collaborate with other BPM Managers to plan and prioritize projects. Maintain relevant planning tools.
- You will create high level process maps in ARIS and provide sufficient detail to ensure all levels of the process can be worked out. Create detailed process flows for selected projects. Review detailed process flows and approve through agreed stage-gate and versioning approaches. Develop the associated training material and have it deployed to the relevant target audience applying a role risk based training methodology.
- You can lead or participate in the development of departmental processes and tools to improve own and departmental work
- You will lead by example and ensure compliance systems are maintained and accurate (training plan, time registration, corporate compliance programs, etc)
- You will participate in partner organization leadership team meetings and individual meetings to ensure processes meet their requirements and keep them informed of progress.

REQUIREMENTS

- Masters Degree in a related area
- Minimum of 8 years experience with medium the large scale projects in matrix organisations
- Knowledge of drug development processes, GxP compliance regulations and quality assurance procedures
- Experience with R&D process requirements and improvements
- CAPA Management
- Experience doing root cause analysis
- Experience in quality activities such as audits, clinical investigative sites and compliance

Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Pascha Groot.