Senior Scientist, Inspection & Audit Team, Quality Systems

at  AGC Biologics

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.
Our Quality Systems department is looking for a highly motivated and experienced Senior Scientist with strong expertise in Internal Auditing to join our Inspection & Audit team.
About the Role:
As Senior Scientist in the Inspection & Audit team, you will serve as the primary Internal Auditor, leading and executing our internal audit program while supporting other activities. This role focuses on developing and implementing internal audit strategies to ensure GMP compliance across our operations. You will work with a team of scientists also responsible for management of regulatory inspections, customer audits, and Quality Assurance Agreements (QAAs) with external customers. This role requires deep knowledge of GMP regulations, strong attention to detail, organization, and is comfortable interacting cross-functionally with internal and external stakeholders.
About the Quality Systems department:
The Inspection & Audit team is part of the Quality Systems department and is an integral part of the Quality organization at AGC Biologics. You will be joining a diverse team of highly qualified colleagues, all with several years of experience within quality assurance. We are actively involved in the constant development and improvement of the quality system and our facility in Søborg and have a close collaboration with our global AGC sites. The team collaborates with partners across all functional areas at the site, to ensure all quality-related activities are carried out effectively, efficiently, and in compliance with cGMP. We keep an open communication with focus on a high level of professionalism. We are open-minded and committed to providing high-quality service to our colleagues in the rest of AGC Biologics– and to our customers, as well.

Responsibilities:

• Internal Audits:

o Lead the development and execution of the site’s internal GMP audit program
o Plan and conduct risk-based internal audits across all GMP-regulated operations
o Author detailed audit reports and track completion of corrective actions
o Train and mentor other team members on audit techniques
o Drive continuous improvement through audit findings and trends analysis

o Ensure internal audit program meets regulatory requirements and industry best practices

• Quality & Compliance:

o Develop and maintain robust internal audit procedures aligned with GMP requirements
o Drive collaboration across site functions to remediate top compliance risks
o Support quality system improvements based on audit findings
o Support the development of inspection and audit programs that ensure continuous compliance with applicable regulations and quality standards.

o Participate in management reviews of quality metrics and trends.

• Regulatory Inspections:

o Assist in the preparing the organization for regulatory inspections (e.g. DMA, FDA, ANVISA, etc.) ensuring compliance with applicable regulations and standards.
o Assist with implementing key inspectional processes such as compliance risk assessment, presenter preparation, logistical infrastructure, inspection staff training program and talent management program for inspection speakers & logistical support staff.

o Contribute to inspection readiness activities.

• Customer Audits:

o Manage all aspects of customer audits, from pre-audit preparation to post-audit follow-up.

• Documentation & Reporting:

o Oversee the preparation of responses to inspection and audit reports, ensuring accuracy, clarity, and completeness.
o Monitor and report on key quality metrics related to inspections and audits, identifying trends and areas for improvement.

o Ensure that all documentation related to inspections and audits is properly maintained and accessible in accordance with regulatory and customer requirements.

• Stakeholder Management:

o Build and maintain strong relationships with customers, and internal stakeholders to foster trust and collaboration.
o Support the maintenance of Quality Assurance Agreements (QAAs) with external customers.
o Communicate effectively with senior management, providing regular updates on audit outcomes, key risks, and improvement initiatives.

Candidate Profile:

• Master’s degree in pharmacy, biochemistry, or related life sciences field.
• The ideal candidate has approximately 5+ years of experience in a quality or regulatory compliance role within the pharmaceutical, biotech, or medical device industry.
• Strong knowledge of regulatory standards (e.g. EU GMP, 21 CFR, ICH) and industry best practices.
• Effective communicator with strong negotiation and presentation skills, able to interact with senior management, regulatory authorities, and customers.
• Proficiency in quality managements systems (QMS) and audit management tools.

Your Application:
Submit your application as soon as possible! We treat the applications as we receive then, and conduct interviews with qualified candidates. When the right candidates are found, this job posting will close.
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
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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

• Internal Audits