Business Process Clinical QA Manager (6 months)

Location: Netherlands

SIRE® is the market leader in Life Sciences recruitment. We believe the recruitment market needs to gear up in technology and continuous innovation. We like technology, in a Life Sciences 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!Our client is a professional Pharmaceutical and Biotechnology organisation, based in Noord-Brabant Netherlands.

The Company

Our client is a professional Biotechnology and Pharmaceutical organization, based in Noord-Brabant Netherlands. Driven by the commitment to patients, the client brings innovative products, services and solutions to people throughout the world.

Role Description

The Business Process Management Expert (BPM Expert) is accountable for a larger section of the procedural framework and is responsible for ensuring that GxP and similar requirements are adequately described. The BPM expert has content knowledge of the area he/she is accountable for and works with partners form 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 BPM expert is responsible for designing, improving and implementing projects related to business processes and the procedural framework for GxP, either as leader or key team member and has to implement a risk based methodology, both on the process as well as on the training side (role & risk based training plans).

Responsibilities

1. The BPM expert will Lead or participate in improvement projects to describe the new desired state of processes for compliance. Gather and analyze metrics, CAPA and other performance data of the existing process, describe requirements and develop with the partners to be processes.
2. The BPM expert 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.
3. The BPM expert will collaborate with other BPM experts to plan and prioritize projects. Maintain relevant planning tools.
4. The BPM expert 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.
5. The BPM expert can lead or participate in the development of departmental processes and tools to improve own and departmental work.
6. The BPM expert will lead by example and ensure compliance systems are maintained and accurate (training plan, time registration, corporate compliance programs, etc).
7. The BPM expert will participate in partner organization leadership team meetings and individual meetings to ensure processes meet their requirements and keep them informed of progress.

Requirements

Master degree or BS/BA with minimum of 8 years’ experience in a medium to large scale matrix organization which includes applicable compliance related field and/or equivalent time and experience in a related R&D area is required. Requires knowledge of the drug development process, good knowledge of worldwide GxP compliance regulations, sound research and development practices, scientific and quality terminology, company quality assurance procedures and policies, and quality evaluation techniques as well as adult training development expertise.