Denmark Job Openings
AGC Biologics
Quality Systems Manager for the Inspection & Audit team
Copenhagen
FULL TIME
September 12, 2024
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Leadership & Team Management
- Lead and mentor a team of scientists specializing in regulatory inspections, customer audits and internal audits.
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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.
- Serve as the primary point of contact during regulatory inspections, coordinating responses, and ensuring thorough follow-up on findings.
- Ensure timely submission on inspection-related documentation, including responses to regulatory authorities.
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Customer Audits
- Manage all aspects of customer audits, from pre-audit preparation to post-audit follow-up.
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Internal Audits:
- Continuous development and management of internal audit program.
- Support execution of internal audits serving as Lead Auditor or Co-Auditor.
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Quality & Compliance
- Manage quality client questionnaires, Requests for Information (RFI) and regulatory submission documentation.
- 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.
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Documentation & Reporting
- Oversee the preparation of responses to inspection and audit reports, ensuring accuracy, clarity, and completeness.
- 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.
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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.
- Master’s degree or Ph D 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.
- Excellent leadership and people management skills, with a focus on fostering collaboration and accountability.
- 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.
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 (p DNA), messenger RNA (m RNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with c GMP-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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