Business Process Management Expert GxP

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).

Process Alignment & Training Support

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.
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.
Collaborate with other BPM experts to plan and prioritize projects. Maintain relevant planning tools.
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.
Lead or participate in the development of departmental processes and tools to improve own and departmental work.
Lead by example and ensure compliance systems are maintained and accurate (training plan, time registration, corporate compliance programs, etc).
Participate in partner organization leadership team meetings and individual meetings to ensure processes meet their requirements and keep them informed of progress.

Your profile

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.

Related Experience

Project Management Skillset
Ability to interpret data to develop action plans to improve business;
Must have strong personal leadership with demonstrated competency interfacing with all levels of the organization including senior leaders;
Strong networking and relationship building skills;
Ability to create an open and inviting environment;
Embraces generational differences;
Exceptional written and verbal communications skills;
Ability to translate data into information and strategies into executable action plans;
Ability to independently plan, organize, coordinate, manage and execute assigned tasks;
Experience of quality related business processes and practices; experience of the overall drug development process is an asset.

Rate

Fulltime highly preferred, hourly rate €80 including travel and telephone costs, excuding VAT and laptop will be provided.

This is a temporary assignment, the role can be done fully remote (with occasional team meets) .

Duration asap to May 2018