R&D Quality Specialist, GCP
5 days ago
R&D Quality Specialist, GCP & PV QA
Are you passionate about clinical and pharmacovigilance quality? Your expertise might be just what we're looking for
Your new role
As Specialist, GCP & PV QA, you will play a strategic role in ensuring compliance with global regulatory standards for Lundbeck sponsored clinical trials and pharmacovigilance (PV) activities. You will manage audits, support regulatory inspections, and foster a culture of quality while driving continuous improvement in audit processes. This position offers a unique opportunity for international travel (up to 30 %) and engagement with key stakeholders worldwide. The role is preferably based in Valby, Denmark.
Your future team
The R&D Quality team is a part of the Global Quality organization. You will join a team of dedicated colleagues who take pride in ensuring regulatory compliance, driving audit excellence, and fostering a culture of quality across Lundbeck's global operations. Our culture is characterized by collaboration, inclusiveness, and a passion for continuous improvement. You will find a supportive environment where innovative ideas are encouraged, and teamwork is celebrated
What you bring to the team
Bachelor's degree in pharmacy, nursing, biology, chemistry, pharmacology, or related discipline.Preferable of 10 years' experience in the pharmaceutical or biotech industry, with at least 5 years focused on GCP and PV audits.Proven expertise in regulatory compliance, audit management, and quality improvement processes.Strong interpersonal and stakeholder management skills, with the ability to build relationships across diverse teams.Strategic thinking and adaptability to work in a fast-paced, global environment.A willingness to travel internationally (approximately 30 %) to support audits and inspections.Your personal competencies include a proactive approach to quality improvement, the ability to work independently, and a strong commitment to fostering a culture of compliance and excellence.Our promise to you
Lundbeck offers an inspiring workplace and innovative culture, where our curiosity, accountability and adaptability enable us to transform lives. We want to go faster and further on addressing the big unmet needs of people living with brain disorders. We offer rewarding careers with a mix of exciting tasks and development opportunities that are balanced with initiatives focused on your well-being.
We need every brain in the game, and at Lundbeck, we are committed to building a workforce that is as diverse as the people we serve. Read more about our commitment at
Apply now
Can you see yourself in this role? We want to hear from you. Does this sound like your dream job, but you're not sure if you meet all the requirements? We still want to hear from you
Upload your CV and include a few lines about your motivation for applying. We ask you not to include a photo or personal information that does not relate to your professional experience.
Applications must be received by November 30th.
Learn more about us at , LinkedIn or Instagram (@h_lundbeck).
#EveryBrainInTheGame
This job ad is intended for individuals seeking a career opportunity with Lundbeck. We engage with recruitment and search firms where needed on the basis of a written agreement, and we do not accept unsolicited requests of any kind. If you work as a recruitment consultant, you are kindly instructed to refrain from contacting Lundbeck or the hiring manager directly with suggested candidates. If you violate this policy, you do so at your own risk and for your own account, and Lundbeck will not assume any liability nor pay any associated fees resulting from such violation.
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