Associate Director, Quality Assurance (Pharmaceutical, Ballerup)

Job summary

This role involves overseeing quality assurance processes within a GMP QC laboratory, focusing on both early-phase clinical development and late-phase commercial activities related to antibody products. The position requires collaboration with various stakeholders to ensure compliance and support continuous improvement initiatives.

Qualifications

• MSc degree or equivalent in a relevant life science field.
• Significant experience in the pharmaceutical industry, particularly in quality roles within regulated QC settings.
• Strong understanding of GMP regulations and their application in clinical and commercial processes.

Responsibilities

• Provide QA oversight for routine GMP QC laboratory activities.
• Foster collaborative relationships with internal stakeholders.
• Review deviations and laboratory investigations as a QA reviewer.
• Support equipment life cycle management and qualifications.
• Contribute to QC-related projects and continuous improvement efforts.
• Assist in the digitalization and optimization of QA and QC processes.
• Participate in audits of suppliers and contract laboratories.

Skills

• Strong analytical skills and understanding of data flows.
• Experience with analytical methods and validations, particularly in biologics.
• Familiarity with implementing digital systems like LIMS.
• Proven ability to work in a multicultural environment with strong English communication skills.

Education

• MSc degree or equivalent in a relevant life science subject.

Tools

• Knowledge of GMP regulations and quality management systems.
• Experience with laboratory information management systems (LIMS) or similar digital tools.