Director, Quality Assurance, Qualified Person - Remote

Overview

As the Director, Quality Assurance, Qualified Person you will be responsible for ensuring all medicinal products are produced at our GMP compliant Contract Manufacturing Organizations and released in accordance with relevant requirements.

In Short

• Batch release/Certification of medicinal products for the EU and UK market.
• Implement and support QMS practices and procedures.
• Point of contact for regulatory inspections.
• Ensure compliance with EU Quality Management System.
• Maintain qualification for suppliers of materials.
• Provide guidance for new product introduction.
• Participate in review of Quality Agreements with CMOs and CSPs.
• Assess change controls and deviations during production.
• Oversight of GDP responsibilities.
• Other duties as assigned.

Requirements

• Relevant university degree in a Life Science discipline.
• Experience as a Qualified Person with non-sterile medicinal products.
• Experience managing regulatory inspections.
• Ability to manage supplier quality issues.
• Proficient in English and German.
• Willingness to travel for responsibilities.

Benefits

• Opportunity to work in a leading pharmaceutical company.
• Engagement in meaningful healthcare solutions.
• Collaborative work environment.
• Professional development opportunities.
• Competitive compensation package.