Program Quality Manager

Job summary

This role is for an experienced Quality Assurance professional focused on ensuring high-quality standards in biopharma manufacturing processes. The position involves acting as a key liaison between customers and internal teams, managing quality-related communications and activities throughout commercial and Tech Transfer programs.

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 matters during commercial and Tech Transfer processes.
• Facilitate discussions regarding deviations, changes, CAPAs, and complaints.
• Prepare communications for customers on specific quality topics.
• Assist in revising Quality Agreements and support manufacturing activities.
• Participate in customer visits and audits.
• Develop and maintain departmental documents, including presentations and SOPs.
• Engage in continuous improvement activities and perform ad hoc tasks as needed.

Skills

• Excellent verbal and written communication skills, with fluency in English.
• Strong service orientation and ability to manage stakeholder relationships effectively.
• Positive, organized, and detail-oriented mindset, capable of maintaining an overview in dynamic environments.

Education

• Master’s degree in a relevant scientific discipline.

Tools

• Familiarity with quality assurance tools and methodologies in the biopharma industry.