Senior Scientist, Inspection & Audit Team, Quality Systems

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 data-driven Senior Scientist for the Inspection & Audit team.

About the Role

As Senior Scientist in the Inspection & Audit team, you will work together with a team of scientists responsible for management of regulatory inspections, customer audits, and internal audits. This role's key responsibilities will be to drive data-based quality improvements through metrics analysis and reporting across all audit and inspection activities. The Senior Scientist will take ownership of developing robust reporting frameworks, identifying trends, and implementing continuous improvement initiatives. This role requires strong analytical skills, attention to detail, and the ability to translate data insights into actionable recommendations.

About the Quality Systems department

The Inspection & Audit team is part of the Quality Systems department and is an important 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          

• Regulatory Inspections
  • Prepare the organization for regulatory inspections (e.g. DMA, FDA, ANVISA, etc.) ensuring compliance with applicable regulations and standards.
  • Implement 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.
  • Support inspection readiness activities through data analysis and trend identification
  • Assist in the preparation of audit and inspection responses by providing relevant metrics and trending data
• Customer Audits
  • Manage all aspects of customer audits, from pre-audit preparation to post-audit follow-up.
• Continous Improvement:
  • Analyze trends and patterns across different types of audits and inspections to identify systemic issues
  • Lead data-driven improvement initiatives based on audit and inspection findings
  • Coordinate with cross-functional teams to implement corrective actions and preventive measures
  • Monitor the effectiveness of improvement initiatives through targeted metrics
  • Identify best practices and opportunities for standardization across programs
• Quality & Compliance
  • Develop and maintain robust inspection and audit programs that ensure continuous compliance with applicable regulations and quality standards.
  • Drive collaboration across site functions to remediate top compliance risks and engage in cross-functional planning to leverage resources to improve speed of resolution.
• Documentation & Reporting
  • Oversee the preparation of responses to inspection and audit reports, ensuring accuracy, clarity, and completeness.
  • Ensure accuracy and completeness of quality metrics and trending data
  • Monitor and report on key quality metrics related to inspections and audits, identifying trends and areas for improvement.
  • Ensure that all documentation related to inspections and audits is properly maintained and accessible in accordance with regulatory and customer requirements.
  • Create regular reports highlighting key risks and improvement opportunities.
• Stakeholder Management
  • Build and maintain strong relationships with regulatory authorities, customers, and internal stakeholders to foster trust and collaboration.
  • Communicate effectively with senior management, providing regular updates on inspection and audit outcomes, key risks, and improvement initiatives.

Candidate Profile

• Master’s degree in pharmacy, biochemistry, or related life sciences field.
• 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.

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.