For one of our well known clients we have been asked to look for an experienced Manager Business Process Control (QMS).Do you want to contribute by structuring and building optimal business processes and their compliance according to ISO standards and process controls (J-SOx)?

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Overzicht

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Your role

You will lead the ambitious Business Process Control team, consisting of a QMS Specialist and an Internal Auditor J-Sox. This team is responsible for the design, improvement and compliance controls of the business processes within the EMEA region.

In this position you drive, guide and support business processes, ensuring that ISO relevant processes are correctly described and the required ISO certification is maintained within the EMEA region.

Through the correct identification, documentation of required actions and policies, conformity tests and continuous monitoring you and your team ensure that processes are continuously up to date. You will secure that the QMS is consistent and check the effectiveness of the QMS processes.

You have the following responsibilities:

• Monitor and follow up internal and external audit deficiencies and resolve them together with the relevant departments;
• Develop, implement, supervise and perform ISO and J-SOx audits in accordance with applicable procedures and standards;
• Audit projects, deliverables, operational processes, report findings, and drive improvement;
• Drive and manage the optimizations and improvements as a business partner;
• Support the execution of the process protocols;
• Develop and manage various operational (process) quality frameworks and tools (e.g. performance, tracking, scheduling, quality tools);
• Develop and manage procedures and systems to measure, analyze and report operational results;
• Identify and report opportunities for process improvement and development;
• Maintain an overview and solve the business issues at a detailed level;
• Inspire and motivate stakeholders involved to further integrate the processes.

About you

A person who is excited by the unique professional challenges to optimize and structure processes. We are looking for a driver and executor who continuously strives for excellence structure and knows how to lead change. You are a self-starter, having organizational and analytical skills and are able to proactively and independently resolve issues in creative ways. You have a hands-on mentality and demonstrates resilience in challenging situations.

With your positive approach, you can inspire others to adopt the mentality of prioritizing quality above all else.Together with the team you always ensure optimal quality and improvement of processes. With your enthusiasm you make a positive contribution to this team. You have a proven track record in a similar role and qualifications as:

• Relevant university degree preferred combined with strong analytical skills;
• Easy to see through processes and an initiative-taking character;
• At least 5 years of experience in optimizing and improving processes in QMS in an international environment, including compliance management, preferably in a medical device or pharma company;
• Proven experience in leading auditing processes, incl. coordinating audits by external bodies;
• Experience in managing a (small) team;
• Experience with and full understanding of ISO 9001, ISO 14001 and preferably ISO 13485 and ISO 27001;
• You are accurate, detail oriented, process & structure driven and able to see the big picture (end-to-end approach);
• Proven ability to successfully incorporate and manage stakeholder needs throughout a project;
• Strong communication skills and able to maintain contacts at various levels in an international environment;