At Boehringer Ingelheim, we develop pioneering therapies and health solutions, many of them crucial for patients’ survival. Our team is made up of 52,000 colleagues worldwide. We are a family company and maintain that family feel despite our size. So we want our people to have it really good – from their salary, to tip-top technical facilities, to job security. (Not to mention our spectacular canteen and trendy cafés on campus …)

Now we are looking for a Global (Principal) QM Auditor with focus on GCP for our development sector.

This position can be filled in Germany (Ingelheim or Biberach) or in the US (Ridgefield).

Details of the job

We work with clinics and medical practices around the world that implement our studies. Your job is to scrutinize how these studies are performed – in Clinical Development and Operations, Translational Medicine, Biostatistics, and Data Management.

To do so, you will travel to the site of the action – for example Poland, Japan, or the US – and check... out the state of affairs: Has everything been documented correctly? Are all devices working as they should? Has patient consent been obtained? Have all BI requirements been fulfilled?
You will also audit our partner companies – app developers, raw material suppliers, device manufacturers, and so on. These days some of our work is done remotely, so you won’t always have to travel. Your to-do list also includes internal Boehringer Ingelheim computer system audits, process compliance, and much more.

You will generally perform these audits by yourself, but you will also have a team around you and regularly exchange information. Has one of your colleagues been to a country where you’re about to perform an audit? Are there new legal requirements? We support one another with knowledge wherever we can.

In addition, for the Global Principal QM Auditor position you will prepare, conduct and report complex routine as well as sensitive for-cause audits (internal and external audits). Also, you act as a subject matter expert for specific auditing areas and lead projects within the auditing function and / or cross-functionally.

Your skills, your experience and what makes you who you are
Audits are usually a stressful experience for auditees. After all, who enjoys being scrutinized? This is where your talent for communication comes into play: You will create a friendly atmosphere, listen, respond to the people involved in the discussion ... We have found that this encourages people to open up and really talk about the challenges they are facing.
• You have a Bachelor’s degree in Medicine, Pharmacy, Life Science, or any other relevant field. You may also have a Master’s degree or equivalent.
• The more auditing experience you have, the better. Several years would be good. Alternatively, you have held a leading role in pharma quality management. Clinical data management and biostatistics are your area? Great!
• You’re familiar with GCP regulations and legal requirements.
• You will communicate in English all the time – both verbally and in writing. It would be perfect if you could also speak German.
• Our many computer systems can be challenging at first, but don’t be intimidated. We’ll show you how everything works in minute detail.
• When you are interested in the more senior position as a Global Principal QM Auditor we will additionally ask for the following skills on top with robust experiences in at least one GxP area, quality management and/ or long-term experience in a Medicine function.
• You are a global strategic thinker in all areas paired with in-depth knowledge of all Medicine relevant regulations and processes in HPBU and IU
• You are experienced in project management and have an excellent ad-hoc decision making in a highly regulated regulatory environment
• You will lead a team and therefore it would be great if you have some leading experience
• Advanced intercultural communication, internal consulting and change management skills

Things to look forward to
• We are a research-driven pharmaceutical company – you will have your finger on the pulse of scientific progress.
• Our customers come from all around the world. Your audits will bring you into contact with many different cultures, so things will never get boring.
• Do you prefer to work from home or in the office? We can discuss.
• To learn more about the benefits that await you, please visit our Careers page.

Sounds good?
Then get in touch. We’re already looking forward to meeting you.
Contact details

If you want to apply for the position in the US please use this link:
SAD/AD, GCP Data Management Global Auditor-Remote | BI Careers (boehringer-ingelheim.com)

If you want to apply for the position in Germany (Ingelheim or Biberach) click "Apply now
Germany

Salary Criteria