One should work on the process, not the outcome of the processes
Over de functie
Yacht Life Sciences has a vacancy for a Business Process Manager at our client, a global biotechnological company. Location can be flexible and include Leiden, Breda and Beerse (Belgium).
The Manager, Business Process Management (BPM) is accountable for a larger section of the procedural framework and is responsible for ensuring that GxP and similar requirements are adequately described. The Manager Process Management 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. He/she is responsible for implementation, improvement and design projects related to the procedural framework for GxP and business processes, either as leader or key team member and has to design and implement Role Risk based training plans.
The Business Process Manager (BPM) will contribute to the development of a quality system that enables the Global Clinical Development Organization (GCDO) to conduct clinical trials in an efficient and compliant way, resulting in clinical programs that allow for seamless registration of the compounds.
Accountabilities: The BPM 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.
1. The BPM 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.
2. The BPM will collaborate with other BPM Managers to plan and prioritize projects. Maintain relevant planning tools.
3. The BPM 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.
4. The BPM can lead or participate in the development of departmental processes and tools to improve own and departmental work
5. The BPM will lead by example and ensure compliance systems are maintained and accurate (training plan, time registration, corporate compliance programs, etc)
6. The BPM will participate in partner organization leadership team meetings and individual meetings to ensure processes meet their requirements and keep them informed of progress.
The BPM is a professional function that contributes to the clinical development process in R&D supported by BRQC. Decisions made and problems solved will involve process and training development, working with various stakeholder groups both within BRQC and outside of BRQC, providing technical and content expertise to teams, reporting and summarizing to cluster leads and management.
Masters 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.
- 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;
- Experience in R&D process requirements to successfully drive Q&C productivity, strategy optimization, process improvements and efficiencies including development and management of CAPA and facilitation of Root Cause Analysis
- Ability to translate data into information and strategies into executable action plans.
- Ability to motivate professional colleagues and stakeholders
- Conflict resolution/management and negotiation skills
- Ability to independently plan, organize, coordinate, manage and execute assigned tasks
- Experience of the key customers’ business processes and practices; experience of the overall drug development process is an asset
- Experience in quality activities, including audits of clinical investigative sites, compliance support and audits of regulatory submissions is an asset
This is a full-time role and can be performed from the office in Leiden, Breda or Beerse (Belgium). This role can be performed by a freelancer (ZZP) as well.
We will offer a competitive benefits package in line with the seniority of the position. You will become a member of a strong professional network who shares your education, ambitions and competencies. This will enable you to interact with your colleagues and become a member of the YACHT network, which stretches the Life Science industry. You will be challenged by your peers and will be able to follow courses and training via our Yacht Academy and keep your knowledge and skills up-to-date: boosting your career through personal and scientific growth.
A global biotechnological company that develops, acquires, and commercializes pharmaceutical products and biopharmaceutical therapies.
Voor meer informatie neem je contact op met Edwin Parlevliet via telefoonnummer 06-12387998
Werken voor Yacht
Yacht is dé organisatie van en voor professionals. Wij verbinden professionals en organisaties die het verschil willen maken. Ons doel is optimaal resultaat: jou als professional uitdagend werk bieden waarmee jij de organisaties van onze opdrachtgevers blijvend verbetert. Behoor jij tot de beste professionals in jouw vak? Wil je samen met vakgenoten het verschil maken bij toonaangevende organisaties? Dan willen we jou graag leren kennen.
Uiteraard staat deze vacature open voor zowel mannen als vrouwen.