“Quality is not an Act: It is a Habit”
About Beyond Compliance
By providing project-based support, training, workshops and inspiration sessions, Beyond Compliance facilitates organisations in fostering a healthy quality culture.
Traditionally, quality management tends to focus primarily on the processes and technology. More focus on the people side of quality management can ultimately lead to a significant cost reduction, an increased efficiency and a positive work atmosphere.
A quality culture will help organisations in doing things – as much as possible – the “first time right”, and will ensure continuous audit- and inspection-readiness through:
- Building quality and compliance into the design of processes, systems and projects; and
- Adequate management of quality risks.
This can only be successful with:
- Quality built into the organisational structure, management and communication; and
- Motivated, quality-minded individuals who feel supported and comfortable to speak up, demonstrate critical thinking and share ideas.
Beyond Compliance is ready to support your organisation in taking the first or the next steps in fostering the right quality culture and cultivating quality mindsets.
Mission and Vision
Mission
No one is waiting for errors, quality issues and audit or inspection findings without seeing the desired improvement. Unnecessary recurrence is cost- and time-consuming. It affects your company’s reputation and it brings down morale.
Whether quality issues and findings are the result of organisational changes, mergers, growth, or not: In all cases it means that you need to react on what already went wrong.
Wouldn’t it be great when you can limit quality issues and findings to the inevitable? When you experience the feeling that quality management can work for instead of against you?
Beyond Compliance would like to facilitate organisations, departments and teams in developing a proactive, continuous learning and improvement approach towards managing the quality of services and / or products, in establishing a healthy organisational quality culture and by cultivating the right quality mindset.
Vision
Beyond Compliance aims to be a trusted consultancy, facilitating impact organisations in process development, optimisation and cultural change initiatives, whether this be a change to build the right quality mindset or a change to make a positive impact on society.
Anyhow, such cultural change should help these organisations to excel while it will provide room for efficiency, sustainability, innovation and motivated staff.
Values
Connection
Delivering value through building connections and establishing proactive and close collaboration with management, teams, individuals and other contributors
Empowerment
Encouraging individuals to speak up and to contribute to organisational improvement
Growth
Cultivating mindsets focused on development and innovation through creating a safe environment, and through promoting critical thinking and proactively sharing lessons learned
Passion
Sharing knowledge and expertise, and delivering quality, with energy and passion
Impact
Delivering a positive contribution to society
Who's behind Beyond Compliance?
Beyond Compliance is based in Deventer, the Netherlands, and has been established by Henrieke de Bie.
Henrieke has almost 25 years of experience in the life science industry (including >17 years in quality management), in different GxP areas, with a primary focus on clinical research and pharmacovigilance.
A detailed Curriculum Vitae can be provided upon request.
Working experience
Henrieke started as a GMP Quality Manager at a pharmaceutical plant, followed by a short period in fundamental lab research. She continued her career in 2001 as an all-round Clinical Research Associate managing clinical trials ranging from phase 1 until / including phase 4.
In 2007 she moved into quality assurance. Since then she has worked in different international auditor, consultant and strategic and tactic leadership roles in large contract research organisations, consultancy firms and pharma / biotech companies. In these roles she performed more than 200 multiple day audits in 35+ different countries. She supervised large audit programs, supported regulatory inspections (including EMA, MHRA and FDA) and managed several international clinical and pharmacovigilance (PV) quality teams.
In 2021 Henrieke decided to leave her position as Director PVQA at Astellas, to start her own company Beyond Compliance with the aim to support organisations in looking at quality of their business “beyond compliance”, in fostering an organisational culture which does not only focus on (proactive) regulatory compliance, but also on operational excellence providing room for efficiency, sustainability, innovation and motivated staff.
Education
Next to a propaedeutics in Medicine and a Bachelor in Biochemistry (graduated Cum Laude), Henrieke holds a Master of Science in Quality Management in Scientific Research and Development from the Cranfield University (UK), for which she won the Prize for the Best Student in 2018.
Henrieke completed her Master study with a thesis titled “Quality Culture in the Pharmaceutical Industry: Awareness and Assessment in Clinical Research, compared with Manufacturing”.
In addition, Henrieke followed intensive post-academic courses in behaviour science and leading cultural transitions.
