Principal Scientist, Quality Systems (On-site, Søborg)

Job summary

This role involves significant responsibility in managing regulatory inspections, customer audits, and internal audits within a global Contract Development and Manufacturing Organization (CDMO). The Principal Scientist will lead the internal audit program and inspection readiness strategy, ensuring compliance with regulatory standards and driving quality improvements.

Qualifications

• Master's degree in pharmacy, biochemistry, or a related life sciences field.
• Minimum of 7 years of experience in internal audits or as an internal lead auditor in a GMP-regulated environment within the pharmaceutical, biotech, or medical device industry.
• Solid knowledge of regulatory standards (e.g., EU GMP, 21 CFR, ICH).

Responsibilities

• Prepare the organization for regulatory inspections (e.g., DMA, FDA, ANVISA, MFDS) and ensure compliance with applicable regulations.
• Plan, lead, and execute internal audits across site functions, identifying compliance gaps and driving effective resolutions.
• Manage all aspects of customer audits, from pre-audit preparation to post-audit follow-up and CAPA management.
• Analyze trends to identify systemic issues and lead cross-functional corrective and preventive actions.

Skills

• Proficiency in Quality Management Systems (QMS) and audit management tools.
• Strong communication and negotiation skills with senior management, regulatory authorities, and customers.
• Personal characteristics such as diplomacy, integrity, critical thinking, attention to detail, and the ability to influence and collaborate across functions.

Education

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

Tools

• Quality Management Systems (QMS) and audit management tools.