Business Process Manager (QA)

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.

Our client is a pharmaceutical company that is developing medicine and treatments for different kinds of diseases (cardiovascular, immunology etc..). For their location in Leiden they are currently looking for a Business Process Manager for a 13 months project.

ROLE DESCRIPTION

As a Business Process Manager you are responsible for the implementation, improvement and design projects related to the procedural framework for GxP and business processes, and implement Role Risk based training plans, as well as 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.

RESPONSIBILITIES

- 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 Managers to plan and prioritize projects.
- create high level process maps in ARIS and create/ review detailed process flows for selected projects. Develop 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
- 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.

REQUIREMENTS

- Bachelor or Master with + 8 years of experience in a related area
- Requires knowledge of the drug development process,
- good knowledge of worldwide GxP compliance regulations and QA procedures/ policies
- good research and development practices, scientific and quality terminology
- quality evaluation techniques as well as training development expertise
- strong leadership experience
- 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
- Experience in quality activities, including audits of clinical investigative sites, compliance support and audits of regulatory submissions is an asset

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