Senior Quality Assurance Manager (Biopharma, Remote)

Job summary

This role involves overseeing quality assurance processes in collaboration with biopharma companies, ensuring high standards in Drug Substance, Drug Product, and Finished Goods manufacturing. The position requires strong communication skills and the ability to navigate complex stakeholder environments.

Qualifications

• Master’s degree in Biochemistry, Biology, Biotechnology, Pharmaceutical Sciences, or a related field.
• Minimum of 10 years of relevant QA experience, particularly in GMP and quality systems.
• Proven experience in managing relationships between internal processes and external customers.
• Excellent verbal and written communication skills in English.

Responsibilities

• Serve as the primary contact for customers on quality-related topics during commercial and Tech Transfer processes.
• Facilitate discussions with customers regarding deviations, changes, CAPAs, and complaints.
• Prepare communications on specific quality topics for 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 customer presentations and SOPs.
• Engage in continuous improvement initiatives and perform ad hoc tasks as needed.

Skills

• Strong service orientation and ability to manage stakeholder relationships effectively.
• Detail-oriented with strong organizational skills, able to maintain oversight in dynamic environments.
• Team-oriented mindset with a collaborative approach.

Education

• Master’s degree in a relevant scientific field.

Tools

• Familiarity with quality management systems and documentation practices in a biopharma context.