Corporate compliance is often discussed in abstract terms. It’s seen as the policies, frameworks, and systems that sit somewhere in the background of pharmaceutical operations. Given that good manufacturing practice (cGMP) rightly dominates conversations around quality and safety, it can be easy to assume that compliance begins and ends with meeting regulatory requirements. Beyond that, corporate compliance at Vetter means aligning with all legal and internal requirements while fostering a culture of integrity and ethical responsibility.
In today’s world with rising legal complexity and expectations from customers, companies must go further and consider issues such as sustainability and human rights, as well as their overall corporate culture. Such areas don’t always fit neatly into traditional compliance checklists.
To better understand what corporate compliance really looks like in practice in pharma, we spoke with Jana Falkenberg, Senior Legal Counsel and Corporate Compliance Officer at Vetter. She explains why compliance shouldn’t be treated as a box-ticking exercise – and how it can add true value to a company.
What does the role of a corporate compliance officer involve?
As Senior Legal Counsel and Corporate Compliance Officer at Vetter, my role centers on maintaining, training, and continuously improving and monitoring our compliance management system and how it is being experienced.
This is part of the broader risk management systems that companies usually have and is about identifying and mitigating risks related to legal, corporate, and ethical issues, and making sure we stay compliant.
Day to day, I work closely with my colleagues in the organization to plan and carry out a wide range of activities. We need to reinforce the necessity of corporate compliance and the benefits of acting compliantly. We continuously develop innovative formats and targeted content to maintain a high level of compliance awareness throughout the organization.
Another part of my role is acting as a point of contact for compliance-related consultation requests, but it’s not just about departments coming to us for advice. We actively seek input from departments to understand their challenges and provide tailored compliance support. We can only help departments to stay compliant if we understand what their issues are.
This is very much a continuous learning process and makes my role both challenging and rewarding.
How would you define corporate compliance in the pharma industry?
In pharma, we all know that good manufacturing practices and the maintenance of quality management systems are essential for regulatory adherence. But corporate compliance efforts extend beyond this. Traditionally, corporate compliance may have come from a more legal-focused perspective that included aspects such as anti-corruption, anti-money laundering, antitrust law, and so on. However, at both the EU and national levels, there are now many regulations related to sustainability and human rights that have come into force in recent years. We also shouldn’t forget public expectations in terms of how they expect companies to behave. Vetter’s compliance strategy integrates for example global standards such as the UN Global Compact and SBTi, reinforcing our commitment to sustainability and diversity.
Effective corporate compliance goes far beyond just avoiding penalties. It should foster a culture of integrity, strengthen partnerships, and build credibility with regulators. Our customer base includes leading global pharma and biotech players. They all have their own compliance management systems to uphold compliance with legal and ethical requirements.
For us, as a global Contract Development and Manufacturing Organization (CDMO), being able to say with conviction, “Yes, at Vetter we are committed to acting with integrity; to being a loyal and trustworthy partner, and to maintaining a robust compliance management system at a comparable level,” plays an important role in strengthening partnerships with our customers – it is a true sales argument.
And if we look at the employees, we want to make sure that they work passioned and motivated. Corporate compliance helps to create and maintain a corporate culture with clear rules and an environment where people treat each other with respect and fairness, and where tolerance is part of everyday behavior. Highly motivated employees consistently deliver exceptional results. They have fewer absences, and they are less likely to leave their jobs. In this sense, compliance contributes something very tangible.
In the end, it’s about promoting transparency, shared values, and taking a holistic approach to compliance. Compliance is not confined to legal teams; it is a shared responsibility embedded across all business functions. That’s how we meet the expectations of all stakeholder groups, including regulators.
When it comes to developing a compliance strategy, what are some of the most common risks that can be overlooked?
To meet quality-related requirements, companies must maintain very robust quality compliance systems. Some companies may have many employees dedicated to this topic. However, this can sometimes lead to the perception that, “If we’re good on the quality side, then we’re fine.” But what can be overlooked is that there are still additional risks, even for pharmaceutical companies, in areas such as third-party relationships, labor law, human rights, environmental issues, and ultimately company culture. For example, insufficient vetting of suppliers can expose a company to unethical practices or sustainability failures. This can lead not only to financial damage, but also to reputational harm.
To address these risks, it’s important to include risk-based due diligence in the compliance strategy, as well as clear codes of conduct for both employees and business partners. Another key element is maintaining open reporting channels.
You want to know what’s going on as early as possible – because the earlier you recognize that something is going wrong, the easier it is to intervene and resolve the issue.
Is it especially challenging when you’re dealing with a global environment?
For us as a CDMO, there are really two main challenges.
The first is the set of requirements that we ourselves must comply with. We’re a company located within a specific legal framework, so of course we have to monitor developments on a regular basis. For instance, we need to understand whether new legislation affects us and whether we need to implement something new internally.
European legislation is not getting any easier to deal with. There have been many new rules and provisions coming into force, which often leave a lot of room for interpretation. That can make it challenging to come up with pragmatic solutions that really work for the company while still fully complying with external legal requirements.
The second challenge comes from our role as a German pharma service provider. Many of our customers are global, which means they may be subject to regulations that don’t formally apply to us or are in conflict with local provisions or requirements. We have to take a close look at our customers’ requirements and ask ourselves how we can support them.
How do you truly embed compliance into the culture and avoid it becoming a tick-box exercise?
Companies must move beyond checklists. We have to create a culture where corporate compliance is part of everyday decision-making in all departments.
Of course, if you have a compliance management system, you’ll have a code of conduct, tailored training formats, and collaboration across departments. But in general, it’s important to keep the topic visible and relevant for all stakeholders – and to do this on a continuous basis.
You can use a variety of channels to achieve this. You can look at your internal communication channels and make sure compliance appears there regularly. You can also consider departmental deep dives. In training sessions, you can usually only give a general overview, and there are often groups or departments that want or need more detailed information. Going directly into departments and talking about corporate compliance topics that are particularly relevant for their specific work can be very effective.
You can also conduct regular surveys and interviews to identify risks and understand where people see challenges. At Vetter, we held a company event called Compliance Week, where we provided information about corporate compliance topics in a more playful way using escape games and a wheel of fortune.
A real compliance culture starts at the top. When leaders don’t just set expectations but actively model them, compliance becomes embedded in everyday behavior.
It’s really important to try different ways to make the topic engaging and keep awareness high.
What are the biggest misconceptions people have about corporate compliance?
Especially from a management perspective, corporate compliance is often just seen as a way to prevent problems and avoid penalties or fines. However, corporate compliance can really create value. Internally, it contributes to a positive and motivated working environment. And externally, the compliance function can help shape how a company is perceived by third parties as a reliable, trustworthy business partner.
Compliance is more than risk mitigation; it is a driver of integrity, trust, and long-term value creation.
How do you anticipate corporate compliance challenges changing over the next few years?
What clearly doesn’t work is silo thinking, such as creating isolated solutions within individual departments. In the past, you might have had one department responsible for coming up with a solution on its own. Today, alignment is essential.
From a corporate compliance perspective, we can’t just show up and say, “There’s a new regulation, go ahead and solve it.” We have to sit down together, discuss the implications, and understand what this means not just for one department, but for the entire company. This requires cross-departmental working.
Another trend I’m seeing is a steady increase in regulation, and we have to accept that implementing new regulations increasingly comes with a lot of uncertainty about which path you need to take to be compliant while at the same time enable your colleagues to pursue the companies’ business.
We’re also seeing regulations that were originally supposed to come into force in 2024 being postponed to 2025, and now there are discussions about pushing them back even further. So even if you decide internally that you need to act and start implementing procedures, you may find yourself ahead of others who are still waiting to see whether the regulation does come into force.
More than ever, you should approach the implementation of new regulations with a sense of proportion. On the one hand, you want to meet regulatory requirements. On the other hand, you must be careful not to paralyze the businesses in the process.
If you had to give pharma executives three simple rules for improving compliance, what would you say?
First, regularly share your own understanding of what acting compliantly means. What does corporate compliance mean to you as the head of the company? And then communicate clearly to your managers what you expect from them in terms of corporate compliance.
The second point is closely related. In the compliance world, we often talk about “tone from the top” or “tone at the top.” You are a role model and people are watching you. If you tell others how they should behave, you need to live that yourself and show what a compliant way of working actually looks like.
The third point would be to support and enable a healthy corporate culture. People need to feel safe speaking up – to mention mistakes or point out when something is going wrong. If they’re afraid to do that, you won’t recognize issues early, and you won’t be able to step in and resolve them.
Executives don’t necessarily create that culture on their own, but it’s essential that they provide the stage for it.
Ultimately, compliance is a cornerstone of sustainable success in the biopharmaceutical sector—fostering transparency, safeguarding reputation, and enabling resilient partnerships.
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