Kalsbeek Consult ApS

Get fast, efficient and empathetic help for interim management tasks, internal audits, specialist tasks and project management within QA and QC.

Pharmaceutical industry | Biotech | Medical Device

Kalsbeek Consult ApS

Get fast, efficient and empathetic help for interim management tasks, internal audits, specialist tasks and project management within QA and QC.

Pharmaceutical industry | Biotech | Medical Device

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Services

I can offer you help ranging from interim management to internal audits. I typically deal with the following tasks:

Interim management for either limited or extended periods. I have experience as interim QC and QA manager in Denmark and abroad

Coach/support for new managers or managers facing difficult managerial tasks

Support in connection with implementation of ISO 13485, MDR 2017/745 for Medical Device and IVDR 2017/746 for In Vitro Diagnostic Medical Device

Performance of Internal Audits in QMS, e.g. ISO 13485 and MDR/IVDR

Project manager in QA/QC

Specialist in QA: Non-conformities, Changes, Review and Release

Specialist in QC: Non-conformities, Changes, Review, Optimisation, Validation

Individual consultancy and sparring on challenges at work, professional or relational, career opportunities or development opportunities in current job

Lectures on leadership – Why will you always succeed when people are in focus?

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Are you in need of other types of help that are not on the list? Then please don’t hesitate to contact me regardless. With more than 25 years of experience as manager and specialist, there’s a good chance that I’ve come across something similar – or at any rate know how to help you proceed. 

If you or your company have jobs abroad that you need help with, you’re also welcome to contact me. I love travelling abroad, where I can offer my knowledge to others and learn from other cultures. In terms of languages, I’m fluent in Danish, English and Dutch.

About Nicoline Kalsbeek and Kalsbeek Consult ApS

Helicopter pilot, Dutch origin and Ph.D. in Chemistry with more than 25 years of experience as manager and expert

My name is Nicoline Kalsbeek. Five years ago, I established Kalsbeek Consult ApS to help companies create greater perspective, direction and new procedures that make (work) life easier, more enjoyable and more efficient. For more than 25 years, I‘ve worked in management or as a specialist within different business areas such as pharmaceuticals, biotech and medical device. In short, I’m a huge fan of change management and transformation processes, and have in-depth insight and expertise in QA/QC tasks and quality management. 

I have a Ph.D. in Chemistry, am further trained in managerial business, and I’ve also completed many courses in people management, quality management, GMP, ISO 13485, MDR, internal audits and project management.

Like everyone else, however, I’m a lot more than what can be seen from a CV (which you can find below, as professional qualifications will of course always be highly relevant).

First of all, you should know that my perspective on management is based on three key values: 1) trust, 2) commitment and 3) freedom with responsibility. It has become increasingly clear to me that these are the most important elements of management, as I have seen the difference that they make in creating the best results. 

Download documentation, presentations and my CV here

Nicoline has strong understanding of business dynamics and value chains and with her always positive mindset, strong people focus, clear communication and strong analytical skills, I felt safe as superior manager to hand over full mandate to Nicoline acting as senior manager in a interim period.

- Maj-Britt Kjær Sand, QA Director, Head of Human Health & HMO, Chr. Hansen A/S

References

Listen to previous business partners talking about their experience of working with me

It’s easy to claim that you’re good at what you do; showing it is another matter. However, I can say hand-on-heart that I’ve never yet completed an assignment without a fundamental feeling that my business partners have been satisfied with me and the work that we’ve carried out together. 

But don’t just take my word for it. Read here what my previous business partners have to say

– as they can say it much better than I can

Nicoline was very successfully taking up a position as interim senior QA manager in my Human Health organization for 4½ month in Chr. Hansen A/S during a challenging period with a growing supply demand and additional focus on well being in the department.

Nicoline brought along her many years of experience, which resulted in a very fast onboarding with strong connection to employees and key stakeholders and she quickly understood the challenges and opportunities during this period of time. Hereby, making Nicoline able to navigate and taking full responsibility as Senior QA Manager in a very complex organization.

Nicoline was delivering results and taking care of employees from day 1.

Nicoline has strong understanding of business dynamics and value chains and with her always positive mindset, strong people focus, clear communication and strong analytical skills, I felt safe as superior manager to hand over full mandate to Nicoline acting as senior manager in a interim period.

After onboarding of the new manager, Nicoline subsequently prolonged her stay 2 month taking lead in implementation of optimization potentials discovered during her time as senior QA manager. This way I was able to harvest some of the opportunities suggested by Nicoline during her 4½ month as Senior QA Manager.

It has been a pleasure working together with Nicoline and I can highly recommend bringing Nicoline into complex situations if you have interim periods without managers while recruiting.

- Maj-Britt Kjær Sand, QA Director, Head of Human Health & HMO, Chr. Hansen A/S

I have had the pleasure of working together with Nicoline via her role as interim manager at our Dublin site. Although she entered during difficult times, it felt like a seamless 'plug & play' transition that bridged the existing leadership gap. Nicoline quickly earned respect for herself and the department she represented. Nicoline managed to reorganize the department into one coherent unit and handed over the organization catered for future results.

Among her many good qualities, I particularly want to highlight her excellent people management skills. Nicoline works primarily through people to create a sustainable impact.

- Martin Faxø, Director, Global Quality Laboratories, LEO Pharma A/S

As interim Senior QC Laboratories Manager Nicoline slotted in quickly, learning and utilizing local systems and practices without issue. She provided much needed support both from a technical and personal aspect. Nicoline has a great skill and experience of working out what topics need to be supported, escalated and actioned upon to help projects and lab activities succeed. I personally think that Nicoline is a great manager and person to work for. I can highly recommend Nicoline!

- Sharon Kennedy, Microbiology Supervisor, LEO Pharma A/S

Jeg kan varmt anbefale Nicoline. Vi har på Fertin Pharma A/S anvendt Nicoline som konsulent i en 6 måneders periode i vores QC afdeling. Der var et behov for at få revurderet arbejdsgange, herunder at få etableret værktøjer til at skabe større forudsigelighed i driftsopgaverne, så det var muligt i højere grad at planlægge disse.

Nicoline var hurtig til at få skabt et overblik og identificere de behov, der var for at få skabt ændringerne. Hendes store faglighed/erfaring sammen med hendes empatiske tilgang og evne til at skabe gode relationer på tværs gjorde, at det var let for hende at få commitment til de foreslåede ændringer.

Vi vil helt sikkert gøre brug af Nicoline som konsulent igen, hvis behovet opstår.

- Sussi Kallesøe, Director, Quality Unit, Fertin Pharma A/S

Jeg arbejdede sammen med Nicoline, da hun var konsulent for Fertin Pharma, hvor Nicoline bl.a. hjalp QC Materials med strukturering og indsamling af data af en planlægningsmodel samt bidrog til et lageroptimeringsprojekt. Jeg oplevede Nicoline, som en fagligt dygtig konsulent, som gennem sine mange års erfaring, som leder og med bl.a. kvalitetskontrol kunne bidrage med kompetent sparring og løsning af opgaverne i høj kvalitet. Det var en fornøjelse at samarbejde med Nicoline og jeg kan varmt anbefale hende som konsulent.

- Mai Østergaard Haven, tidligere Manager, QC Materials, Fertin Pharma A/S

I can highly recommend Nicoline. Nicoline is quick to get an overview and quickly assesses what needs there are in the organization. Nicoline is good at creating positive relationships, which means that she quickly achieves noticeable results in the change management process. Nicoline manages to bring out the best in the people that she works with by being aware of the needs of each individual person as well as the energy she brings into her work. Finally, I would say that she is extremely pleasant to work with.

- Mikkel Malmgaard-Clausen, Quality Systems and Compliance Manager, Takeda Pharma A/S

Nicoline was an empathic, trustworthy, yet strong manager during a challenging time with multiple organisational changes and increased workload. Nicoline trusts you as an employee until proven otherwise. She believes in your skills and supports you in a way that makes the organisation as well as the employees perform and blossom even when times are tough. Nicoline shows you empathy in both work related and private matters and simultaneously drives the organisational transformation with confidence. I can highly recommend Nicoline as manager.

- Heidi Delcomyn Damgaard, Scientific Officer, Lægemiddelstyrelsen

Se her! En fantastisk mulighed for at få fat i en ufattelig dygtig coach. Jeg har haft fornøjelsen af at have Nicoline som manager, da jeg startede min lederkarriere. Jeg kan varmt anbefale hende både menneskeligt og fagligt. Nicoline besidder et solidt helikopterperspektiv og er en god menneskekender. Hun er en god støtte, uanset hvor man er i sin karriere.

- Paul Weisbjerg, QC Manager, Xellia Pharmaceuticals ApS

I have had the pleasure of working with Nicoline, not only as my manager in Xellia pharmaceuticals, but also as a collaborative working partner between our two laboratories, QC and Assay Development in Novozymes A/S. When analytical methods developed are to be transferred from R&D to QC, it is important to have a good communicative line and with Nicoline as manager of ADlab., QC always experienced a good and open atmosphere. As a manager I can highly recommend Nicoline. She is one of those few managers that can be your coach and empower you and at that same time, fulfil the vision and strategy for the team set out by the company. It is not obvious, but to find a woman as empathetic as Nicoline with the guts that Nicoline shows, is unusual to find. I will recommend Nicoline any time.

- Karin Westermann, Specialist QC, Xellia Pharmaceutical ApS

I referred to Nicoline from Jan. 2017 to Feb. 2019, where Nicoline was Senior QC Manager at Xellia. It was an experienced manager who navigated the employees through a turbulent period. Nicoline is a skilled and pleasant manager who I can highly recommend to hire.

- Marianne Skovgaard Nielsen, Senior Specialist, Xellia Pharmaceuticals ApS

Few people have the opportunity to report to a manager who is also a mentor for them — but I did when I worked for Nicoline. I had the pleasure of working with Nicoline for just over a year at Novozymes A/S, where she was my manager at the Department of Assay Technology. At that time, I was at a crucial point in my professional career, transitioning from a research position in academia to the industry. I experienced Nicoline as always available, positive, and supportive. She is really good at listening to and motivating people around her to do their best and to get the team on board with new ideas in difficult times. For me, this meant that I very quickly adapted to my new role at Novozymes and was able to further develop my professional and personal skills, leading several complex projects with a successful outcome. Nicoline is a true role model for me and any employee would be lucky to have her as a manager, mentor, and coach.

- Charlotte Frydenlund Michelsen, PhD, MBA, R&D Project Manager, SolarSack ApS

When I started as a new leader of a team of 15 laboratory technicians at Novozymes, Nicoline provided very competent support and inspiration. We had good discussions about the many facets and dilemmas of the leadership discipline and Nicoline was a valuable coach, when it came to ask challenging and thoughtfully questions about my leadership. I can highly recommend Nicoline as an inspiring and trustworthy coach.

- Ghita Studsgaard Christiansen, QC Manager, Orkla Care A/S

I highly recommend Nicoline as a strong, trustworthy and empathic manager with a broad experience in Quality Management and Quality Control.

After fruitful collaborations with Nicoline in cross-organisational tasks, I have had the pleasure to report to Nicoline when she was appointed, following a major area restructuration, to lead a newly established department in Assay Development and Optimization at Novozymes. The department was to undergo a fusion with part of another department a year later and then shift activity domains after a couple of years. With her voluntary, open and caring personality and her clear communication, Nicoline ensured for all three organizational changes a quick and effective transition involving people on board in a functional team working efficiently together to deliver on ambitious targets.

Nicoline communicates clearly and openly on business targets at all levels. Listening to and challenging stakeholders and direct reports, she quickly identifies main challenges ahead and sets to establish operational solutions in solid trust-based collaborations with accountable commitments. I experienced Nicoline as an inspiring and supportive leader, empowering people reporting to her by encouraging them to develop new skills, use their creativity and take up new responsibilities, thereby bringing the best out of them to deliver beyond expectations.

- Anne Rocher, Analytical Chemist, Novo Nordisk A/S

If you can recognize yourself in some of these situations, then don’t hesitate to reach out to me. It could be a task seemingly identical to one that I’ve previously helped one of the above clients with, but it could also be something different, which I most likely will be able to help you with. If you wish to get started, I’ll be waiting by the phone and my inbox. 

Contact

Don’t hesitate to contact me if you need help

I fully understand that time is of the essence; that you need help NOW. And that the very challenges that I’ll be helping you with mean that your calendar and working day are rarely cohesive or satisfactory – neither for you or your employees, nor perhaps even for your clients. Therefore, you’ll hear from me at the earliest opportunity. 

You're welcome to call me on +45 61 28 82 06 or send me a mail at nicoline@kalsbeek.dk. You can also contact me via the contact form.

Contact Form

Kontaktformular

Mutual trust

In a business relationship it’s important to me that there’s mutual trust. I therefore promise you – even before we’ve begun – that I’ll give you a completely realistic assessment of what is the right help in relation to the challenge that you’re facing. I have plenty of experience in helping companies in difficult and precarious situations. It’s therefore crucial that when help arrives it’s the right help. Anything else is too vulnerable and can eventually lead to even bigger and unmanageable problems.

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