QA Principal Scientist with IT flair, QA Facility & Equipment

AGC Biologics A/S; København; On-site; DKK 900,000 - 1,300,000; Full time

Job summary

AGC Biologics A/S in Søborg is seeking a QA Principal Scientist with IT flair to lead QA for Facility, Utility, Equipment and IT assets, collaborating with IT, Engineering and Project Management.

The role combines QA oversight with IT validation, including CAPA, deviations, change control, and CSV. Requires a Masters in Pharmacy, Biotechnology, Biology, Engineering or IT with 8+ years in regulated manufacturing; English proficiency is essential.

Qualifications

• Master's degree in a relevant field plus 8+ years in regulated manufacturing environments.
• Strong QA background with experience in deviation handling, CAPA and Change Control.
• Knowledge of Computer Systems Validation (CSV) and IT/OT compliance.

Responsibilities

• Provide QA support for complex Deviations (DEV), CAPAs, and Change Requests (CRs).
• Oversee IT Systems, Automation, and Data Integrity to ensure GMP compliance.
• Lead improvements to quality processes and document review/approval of qualification documents.
• Engage in Trend Report analysis for quality activities related to Facility, Utilities, and Equipment.
• Collaborate with IT, Engineering and Project Management across departments.

Skills

QA oversight

Deviation handling

CAPA

Change Control

Qualification documentation review

CSV - Computer Systems Validation

IT/OT compliance

BI and dashboards

Education

Master's degree in Pharmacy, Biotechnology, Biology, Engineering, IT

Tools

SOPs management

Job description

Are you passionate about QA and IT, and do you have high quality mindset? Now is your chance to join a very special role at AGC Biologics in Søborg as a QA Principal Scientist with IT flair, QA Facility & Equipment! Here you can utilize your QA background and help building a strong collaboration with key stakeholders in IT, Engineering and Project Management. As a Principal Scientist, you also get the chance to be supporting and coaching great colleagues and stakeholders across our business. We are looking forward to hearing from you! You will be welcomed by a team of dedicated QA colleagues! QA Facility & Equipment consists of highly qualified scientists with various professional backgrounds and several years of experience within QA. The main responsibility of the QA Facility & Equipment team is the quality assurance of Facility, Utility, Equipment and IT assets. In addition to our team, the QA department consists of the QA for QC team, QA Operations, Quality Systems, and QA Material Management teams. We are actively involved in the constant development within our field and the continuous improvement of our quality system. We aim to constantly ensure that our GMP assets follow current standards for GMP production, i.e., EU GMP, 21 CFR, and ICH guidelines. The QA department fosters open communication with a focus on a high level of professionalism. We are open-minded and highly supportive of our colleagues in the rest of AGC Biologics, as well as our stakeholders.

"We are looking very much forward to welcoming you to our great QA Facility & Equipment team! Your new colleagues are characterized by being positive and proactive, and together we are committed to meeting deadlines through our friendly collaboration with the business." - Sanaz Torab, Senior Manager of the team

Your skills in QA and flair for IT could be the perfect match for this role! As a Principal Scientist in QA IT, you will be involved in various daily tasks in a dynamic and challenging environment. Your main responsibility will be to support our validation team and IT/OT team, which includes: Partner with other Departments/Groups/site for corrections and problem solving and best practices and alignment Review and approve SOP and Qualification Documents (Qualification/validation protocol and report, URS, VPL, RTM, TEQ, CIL etc.) Provides QA support on complex Deviations (DEV), CAPAs, and Change Requests (CRs). Responsible for overseeing IT Systems, Automation, and Data Integrity to ensure compliance with GMP. Lead improvement initiatives aimed to add efficiency to the Quality processes. Review and approve system and equipment related quality documentation Overall quality assurance activities related to the manufacturing facilities, utilities, equipment and computerized systems. Asset Management Related Tasks Support Computerized Systems Validation (CSV) Engage in the compilation and analysis of Trend Reports for quality activities related to Facility, Utilities, and equipment to identify improvement opportunities and driving associated initiatives.

Do you bring solid experience with QA and IT validation? To become our next Principal Scientist in QA, we are looking for someone with a relevant Masters degree in Pharmacy, Biotechnology, Biology, Engineering, IT etc. followed by 8+ years in regulated manufacturing environments, ensuring knowledge of GMP requirements. It is an advantage if you bring experience or an understanding of our CDMO environment. Your solid QA background makes you proficient in QA oversight, deviation handling, CAPA and Change Control and reviewing and evaluating qualification documentation. To succeed in a role which combines QA and IT, we imagine that you have built knowledge in Computer Systems Validation with a strong interest in digitalization and continuous improvement. The core of this position is to be able to support IT/OT compliance to ensure compliance with regulatory requirements. It is a great advantage if you are familiar working with BI and dashboards, since we use these for reporting and presentation purposes. As a colleague, you thrive in a dynamic and challenging environments. We are looking for someone who demonstrates problem-solving skills, reliability in meeting commitments, and provides exceptional stakeholder experiences. You must be self-motivated with a pragmatic attitude towards daily tasks, ensuring high quality without compromise. Our company language is English, so proefssional fluency is a requirement.

We are looking forward to hearing from you!

Who We Are

AGC Biologics is a global Contract Development and Manufacturing Organization with a strong presence in Denmark. From our Søborg site, we develop and manufacture life-changing advanced biologics for some of the world’s most innovative pharmaceutical companies. Together with our team members across Europe, the U.S., and Japan, we deliver development and manufacturing of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells therapies. Across our global network, we are united by one mission: To work side by side with our customers in order to improve patients' lives by bringing new biopharmaceuticals to market. AGC Biologics is Your Friendly CDMO Expert - dedicated partners with the expertise and commitment to support our customers and teams. We work with some of the world’s most innovative pharmaceutical companies to develop and manufacture their life-changing drug products. If you're motivated by meaningful impact and ready to join our journey, we invite you to explore our current opportunities!