Customer Program Quality Manager

Job summary

This role involves ensuring high-quality standards in collaboration with biopharma companies, focusing on Drug Substance, Drug Product, and Finished Goods manufacturing. The position requires a senior Quality Assurance professional to act as a key liaison between customers and internal teams, managing complex quality topics with independence and professional judgment.

Qualifications

• Master’s degree in Biochemistry, Biology, Biotechnology, Pharmaceutical Sciences, or a related field.
• Minimum of 10 years of relevant QA experience.
• Strong understanding of GMP and quality systems.

Responsibilities

• Serve as the primary contact for customers on quality-related issues during commercial and Tech Transfer processes.
• Facilitate discussions with customers regarding deviations, changes, CAPAs, and complaints.
• Prepare and communicate quality topics to customers.
• Assist in revising Quality Agreements and support manufacturing activities.
• Represent quality assurance in core program teams and participate in customer visits and audits.
• Develop and maintain departmental documents, including presentations and SOPs.

Skills

• Excellent verbal and written communication skills; fluency in English is required.
• Strong service orientation and ability to manage stakeholder relationships effectively.
• Positive, organized, and detail-oriented with the ability to adapt in a dynamic environment.

Education

• Master’s degree in a relevant scientific field.

Tools

• Familiarity with quality management systems and documentation practices.