Are you ready to drive change and ensure compliance in the dynamic health sciences sector? Sanos Group seeks a professional to lead and ensure QA and GDPR compliance across multiple GxP areas.
Who are we?
Sanos is a full circle clinical research and development organization with headquarter in Søborg, near Copenhagen, Denmark. The organization consists of around 200 employees, and is composed of six independent business units, each contributing to the comprehensive clinical research services provided. These units include NBCD, Sanos Clinic, Sanos Supply, Studies&Me, Blueskin, and Omicron.
All business units in Sanos are dedicated to providing first-class clinical research, aiming to keep improving and develop how we conduct innovative clinical trials for our clients and patients. We play a critical role in developing new medication and treatment options, and work diligently to bring new medication faster to the patients.
Your key roles and responsibilities
As a QA Director at Sanos you will spearhead QA strategies, ensure compliance with both domestic and international regulations, and ensure that our Quality Management System (QMS) remains robust and up to par with current and ever changing regulations.
Key Responsibilities:
- Serve as the Sanos Management representative for quality and compliance matters.
- Lead the development and maintenance of a QMS with a focus on overarching procedures.
- Ensure compliance with relevant regulations, study protocols, and SOPs across all Sanos operating companies.
- Conduct internal and external audits and manage vendor quality oversight.
- Oversee global computerized systems related to QMS and compliance.
As a Quality Assurance Change Agent at Sanos Group, you will engage in a dynamic and collaborative environment, where your day-to-day activities include:
- Being available for sparring with business unit leads and operational staff to provide guidance and support.
- Supporting teams during external sponsor queries or audits to ensure smooth and compliant interactions.
- Writing and reviewing relevant controlled documents to maintain high standards of quality and compliance.
Travel: Light travel to Danish office locations as well as during supplier audits, as applicable
Work location: Søborg, Denmark
Desired skills and experience
- Degree in Health Sciences.
- Proven management experience and a mindset for constant optimization
- A broad GxP experience from similar roles in biotech, pharma or CROs
- Experience with computerized system validation and implementation of new electronic systems will be considered a plus
- Experience with eQMS module set up (we use SimplerQMS) and continuous optimization will also be considered a plus
Personal profile
In this role, you will thrive as a collaborative and skilled professional who can adeptly navigate changing priorities while maintaining a team-oriented approach.
- You excel in working collaboratively with diverse teams and stakeholders.
- Your ability to find compromise and adapt to shifting priorities ensures effective problem-solving.
- As a team player, you contribute positively to the organizational culture and support collective goals.
Are we a perfect cultural fit?
Our commitment to you is encapsulated in our promise to every one of our employees saying ‘Trust in you – in your development and impact´.
This pledge extends uniformly across all entities within Sanos, ensuring that you feel its effects from the very offset of your interaction.
If you are curious about whether you would thrive within Sanos culture and the Sanos Way of
Leading, reflect on whether you see yourself working within our principles:
- Take on - Responsibility is given, and we inspire you to take it.
- Try out - Explore diverse tasks and grow professionally.
- Team up - We don’t just work together; we thrive together.
Want to know more? Check out the Voice of Sanos Group people here.
Ready to make a real impact?
We look forward to hearing from you, so please send your application through the “apply” link.
We will be performing interviews ongoing in the process and look to fill the position as soon as possible. We close the position when we find the right candidate.
For further information about the role contact COO, Sara Daugaard Popik, at sdp@sanos.com.
If you proceed in the recruitment process, you will go through a few additional steps where both you and we will assess whether this position is the right match for both parties. As part of the recruitment process, we use assessments to ensure the optimal match and the best foundation for future collaboration.
Sanos is dedicated to fostering a diverse and inclusive workplace. We believe that a variety of perspectives leads to better decision-making and innovation. We welcome applicants from all backgrounds and are committed to creating an environment where everyone can thrive.
We value your data and take care to protect it. Please see more information regarding privacy for job applicants here.
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Sanos and its entities kindly requests that unsolicited inquiries regarding job advertisements and candidates from headhunters and recruitment agencies be refrained from. We also do not wish to receive unsolicited inquiries regarding the sale of services and products related to job postings. We ask that this request be respected, and that hiring managers and other employees will not be contacted in this regard.
Start an impactful career with us and learn more about our entities and the people within.
Read more here:
www.sanos.com