Quality Systems Manager for the Inspection & Audit team

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.
Are you our new Quality Manager?
Our Quality Systems department is looking for a highly motivated and experienced Manager for the Inspection & Audit team.
About the Role
As Manager of the Inspection & Audit team, you will lead a team of scientists responsible for management of regulatory inspections, customer audits, internal audits, and documentation supporting customer regulatory applications. This role’s key responsibilities will be to ensure compliance with industry regulations, internal standards, and customer expectations, while driving continuous improvement initiatives within the quality systems. The Manager will be pivotal in coordinating inspection readiness, managing audit activities, and ensuring timely corrective actions are implemented. This role requires 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 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, and you will report to Senior Director for Quality Systems and be part of the leadership team in Quality Systems department.
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 works closely together with the Quality Operations team, and routinely 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

• Leadership & Team Management
• Lead and mentor a team of scientists specializing in regulatory inspections, customer audits and internal audits.
• 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.
• Customer Audits
• Manage all aspects of customer audits, from pre-audit preparation to post-audit follow-up.
• Internal Audits:
• Continuous development and management of internal audit program.
• Support execution of internal audits serving as Lead Auditor or Co-Auditor.
• 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.
• 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.
• 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 or PhD 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.

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

• Leadership & Team Management
• Lead and mentor a team of scientists specializing in regulatory inspections, customer audits and internal audits.
• 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.
• Customer Audits
• Manage all aspects of customer audits, from pre-audit preparation to post-audit follow-up.
• Internal Audits:
• Continuous development and management of internal audit program.
• Support execution of internal audits serving as Lead Auditor or Co-Auditor.
• 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.
• 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.
• 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