Job Description

Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients’ lives by bringing new biopharmaceuticals to market.

At AGC Biologics,we arecommitted to a high standard of quality and execution - because we recognize that meeting the needs of our customers contributes to meeting the needs of providers and patients.As a global CDMO, theInspection &Auditteam plays a vital role in managing regulatory inspections, customer audits, and internal auditsBeing part of this team as a Senior Scientist gives you ahigh visibility role withasignificantscope and responsibility anddirect exposure to global regulatory authorities and key customersWeoffer youan opportunity to own and shape the internal audit program and inspection readiness strategy with room to growand developin our global and GMP-regulated environment

We Are BuildingTheTeamWith2 New Colleagues!

The Inspection & Audit team is part of the Quality Systems department and plays a central role in the Quality organization at AGC Biologics.The team is looking for two highly experienced Senior Scientists to join our team onsite in Søborg, just outside of Copenhagen. You will be joining a diverse team of twohighlydedicatedSenior Scientists and one Studentwith several years of experience within quality assurance. Weenjoy being gathered forbi-weekly team meetings and GMP Grind sessions as well as breakfast on Thursdays andsocial activities!

We are actively involved in the continuous development and improvement of the quality system at our Søborg facility, with close collaboration across our global AGC sites. The team works cross-functionally to ensure quality-related activities are carried out effectively, efficiently, and in compliance with cGMP — with open communication, professionalism, and a genuine commitment to high-quality service at our core. 

We Are Taking Inspections & Audits ToTheNext Level

As a  Senior Scientist, you will be a key contributor in managing regulatory inspections, customer audits, and internal audits. You will play an active role in driving inspection readiness, leading internal audit programs, and spearheading quality improvement initiatives across the site. The core of this position lies in your ability to lead inspectionand auditactivities with confidence and expertise, and to translate experience into tangible quality improvements. This is a senior role in every sense of the word — if you recognize yourself as someone who would like to showcase your internal audit and inspection toolbox and take the team to the next level, you may be exactly the colleague that we are looking for! Driving Inspections, Internal Audits and Customer Auditswill be at the heart of what you do, alongside driving continuous improvement:

• First of all, we will trust you to be one of the driving forces of ensuringregulatoryinspectionsandinspectionreadinessYou will bepreparingthe organization for regulatory inspections (e.g. DMA, FDA, ANVISA, MFDS) ensuring compliance with applicable regulations and standards, as well as driving inspection readiness activities,e.g.compliance risk assessments, presenter preparation, logistical infrastructure, and staff training.
• Secondly, you will be acting as Lead Internal Auditor You will be planning, leading, and executinginternal audits across site functions,identifying compliance gaps and systemic issuesand driving timely and effective resolution. Also, we will encourage you tocontinuouslyimprovethe internal audit program,e.g.scheduling, execution, follow-up, and effectiveness of verification. 
• Finally, you will be trusted to manage all aspects of customer audits, from pre-audit preparation through to post-audit follow-up and CAPA management, providing guidance to SMEs on addressing observations effectively before submission.Further, you will facilitate, negotiate, and maintain Quality Assurance Agreements (QAAs)with customers, ensuring alignment with regulatory requirements and internal quality standards, and driving timely reviews and updates.
• Overall, taking the Inspection & Audit team to the next level requiresa commitment to continuous improvement You will analyze trends toidentifysystemic issues, lead cross-functional corrective and preventive actions, and communicate regularly with senior management on outcomes, risks, and opportunities.

We Are LookingForAnExperienced Internal AuditorFromA GMP-Environment

You will be joining a highly skilled team who values yourscientificknowledge andinsights, sobringing a master's degree in pharmacy, biochemistry, or arelated life sciences fieldgives you the ideal foundationIn order toconduct the above-mentioned audits,you must have experience from internal audits or as an internal lead auditorina GMP-regulated environmentofthe pharmaceutical, biotech, or medical device industryThisset of competenciestypicallytranslatesintoa minimum of+5 years of experience

Further,it is an advantage ifyou bring solid knowledge of regulatory standards(e.g.EU GMP, 21 CFR, ICH),andproven experience in inspection readiness, coaching SMEsthrough audit observations, and the ability to communicate and negotiate confidentlyand clearlywith senior management, regulatory authorities, and customers, supported byproficiencyin QMS and audit management toolsWe know that this requires a key set of personal characteristics, likediplomacy, integrity, critical thinking, attention to detail, and the ability to influence and collaborateacross functions. Finally ,wehighly appreciateif youbringexperience with Front Office and/or Back Office roles during regulatory inspections,facilitatingand managing QAAsanddriving quality improvement initiatives

Would You LikeToMakeAnImpactOnTheInspections& AuditsOfOur Global CDMO?

We hope that this opportunityhascaught youreyeand interest!Ifso, applytoday andno later than April 19Pleasesubmityour CV including a short motivationat the top about whatimpactyou are motivated to makeonthis team and acrossAGC Biologics.If you haveanyLeadAuditor Certificates or similarrelevant documentation, please attach it when you applyWe will review applications on a continuousbasis andexpect to conductthe interview process during April and May, withfirst round interviews in week 18 and second round interviews in week 19.We aim for a start date as soon as possible.If you have any questions before you apply, you are welcome to contact theManager, Joanna Sadiq,on jsadiq@agcbio.com.We are looking forward to hearing from you!

Our culture at AGC Biologics is defined by the six core values: Knowledge, Trust, Quality, Ingenuity, Accountability and Teamwork. Our core values stem from our team members and are embedded into our DNA. They provide a common language and understanding of how we as an organization are connected across three continents. Our core values serve as a compass and reminder of how we achieve our purpose of bringing hope to life for patients around the globe.

AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, every step of the way. We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with cGMP-compliant facilities in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan. We currently employ more than 2,500 employees worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients’ most complex challenges, including specialization in fast-track projects and rare diseases. AGC Biologics is the partner of choice. To learn more, visit www.agcbio.com.  Want to keep posted about our growth and learn more about our company? Follow us on LinkedIn and give us a quick Like on Facebook!

AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. AGC Biologics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sexual orientation, or any other characteristic protected by applicable laws, regulations and ordinances.