Senior Specialist / QA Manager (CMO Operations - Small Molecules)

Senior Specialist / QA Manager (CMO Operations - Small Molecules)

Location: Morges, Switzerland (Up to 2 days of remote work per week) 
Contract Type: Temporary - Starting ASAP (possibility of extension)
Language: Fluent English (C1) required
 

Due to a significant increase in our client activities, we are looking for a Senior Specialist or QA Manager to reinforce a dynamic team of 4 people.

This role is 100% focused on managing the Contract Manufacturing Organizations (CMOs) for small molecules.
You will oversee external operations, covering the entire supply chain from Active Pharmaceutical Ingredient (API) manufacturing up to primary packaging.

Responsabilities
You will act as a true hands-on reinforcement to support the team in daily Quality operations. Expect a fast-paced environment with a high volume of work:

• Routine Batch Release: Perform rigorous documentary reviews and centralize information for the commercial products.

• Supplier Relations: Manage day-to-day interactions and monitor the performance of the CMO partners.

• Event Management: Take charge of the review and processing of product complaints.

• Technical Support: Assist the team with the compilation and review of Annual Product Quality Reviews (APQR).

• Continuous Improvement: Participate in document reviews as part of the ongoing implementation of our new LIMS system.

Profile
We need a hands-on professional who thrives in an operational setting and can get up to speed quickly.

• Education: Academic degree in a scientific field (Pharmacy, Biotechnology, Chemistry, etc.).

• Experience: Proven track record in operational Quality Assurance. Specific experience with "commercial" products is not strictly mandatory if you have strong clinical QA experience and are a fast learner.

• Hard Skills: You ideally possess a solid understanding of API (Active Pharmaceutical Ingredient) manufacturing oversight.

• Soft Skills: You are flexible, proactive, and capable of adapting quickly in a highly active environment.