Manager / Sr. Manager – Quality GMP

Monte Rosa Therapeutics seeks a Manager or Sr. Manager for Quality GMP in Basel to oversee CDMO quality interfaces for clinical programs.

The company is looking for a quality leader to manage the day-to-day quality relationship with Contract Development and Manufacturing Organizations (CDMOs) that produce drug substance and drug product for ongoing clinical trials. This role serves as the primary quality contact for vendors, ensuring compliance and supporting batch release activities.

Responsibilities

• Act as the main GMP/GDP quality liaison for vendors producing drug substance and drug product.
• Oversee vendor qualification, conduct audits, and manage Quality Technical Agreements.
• Track vendor compliance and report potential risks to senior leadership.
• Write and update Standard Operating Procedures for GMP and GDP.
• Create and deliver training on cGMP and other GxP standards.
• Perform risk-based GMP impact assessments in line with international regulations.
• Review manufacturing batch records, analytical methods, validation documents, specifications, and stability reports.
• Collaborate with CMC and Supply Chain teams to support clinical batch release and disposition.
• Lead internal and external quality events, including change controls, deviations, investigations, and CAPAs.
• Contribute quality expertise to CMC sections of regulatory submissions.
• Prepare for inspections and assist in drafting responses to audit findings.
• Ensure GDP compliance for clinical trial material distribution and oversee cold chain processes.

Requirements

• Six years of experience with a Master’s degree in organic chemistry, biology, analytics, or a related life science, or equivalent industry experience.
• Direct experience overseeing external quality for clinical phases.
• Strong background in Quality Management Systems (QMS).
• Deep knowledge of analytical and QC operations, CMC, and regulatory requirements.
• Demonstrated ability to lead cross-functional teams in a matrix environment.
• Skill in solving complex GxP issues and mentoring others.
• Proficiency with electronic QMS platforms.
• Experience in start-up or lean-team settings.
• Fluent English communication skills.

Nice to have

• Familiarity with Qualified Person (QP) batch certification under EU Annex 16.
• Experience as a GDP Responsible Person.
• Additional language skills in German, French, or Spanish.

About the company

Monte Rosa Therapeutics operates in a start-up or lean-team environment, functioning without extensive infrastructure. This setting requires adaptability and a hands-on approach to quality management.

• Work in a start-up or lean-team environment.
• Operate without extensive infrastructure, requiring agility.