Senior Scientist, Quality Assurance (Biopharmaceuticals, Onsite, Copenhagen)

Job summary

This role involves significant responsibility in managing regulatory inspections, customer audits, and internal audits within a GMP-regulated environment. The position offers opportunities to shape the internal audit program and inspection readiness strategy while collaborating closely with global teams.

Qualifications

• Master's degree in pharmacy, biochemistry, or a related life sciences field.
• Minimum of 5 years of experience in internal audits or as an internal lead auditor in a GMP-regulated environment of 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, ensuring compliance with applicable regulations and standards.
• Act as Lead Internal Auditor, planning, leading, and executing internal audits, identifying compliance gaps, and driving timely 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

• Strong communication and negotiation skills with senior management and regulatory authorities.
• Proficiency in QMS and audit management tools.
• Personal characteristics such as diplomacy, integrity, critical thinking, and attention to detail.

Tools

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