QA Senior Specialist

We are seeking an experienced QA Specialist to support quality oversight activities across external manufacturing partners. The role focuses on ensuring compliance with GMP requirements, maintaining quality systems, and managing quality events related to commercial pharmaceutical products.

• Oversee quality activities at external manufacturing and testing partners.
• Review and approve deviations, investigations, change controls, complaints, and validation documentation.
• Support batch release activities and product disposition decisions.
• Ensure compliance with GMP/GDP requirements and internal quality standards.
• Maintain quality agreements and collaborate closely with contract manufacturers.
• Participate in audits, inspections, and supplier quality management activities.
• Monitor quality metrics, trends, and continuous improvement initiatives.
• Contribute to quality system maintenance, SOP updates, and regulatory inspection readiness.

• Bachelor's or Master's degree in a scientific discipline.
• Minimum 3 years of Quality Assurance experience within the pharmaceutical industry
  .
• Experience with sterile manufacturing is essential.
• Solid understanding of GMP/GDP regulations and pharmaceutical quality systems.
• Experience managing quality activities with external manufacturers or CMOs.
• Strong analytical, problem-solving, communication, and stakeholder management skills.
• English fluent;
  German is highly desirable.
• Experience supporting regulatory inspections and audits is advantageous.

Occasional travel may be required.