QA Operations Manager TRD (m/w/d)

Shape the Future of Pharmaceutical Quality Excellence in Technical Research & Development

• Duration: 1 year temporary assignment 
• Location: Basel area, Switzerland
• Type: Temporary position
• Salary: 60 - 73.50 CHF / Hour

About Our Client

For our client, a leading pharmaceutical company in the Basel region specializing in innovative drug development and technical research, we are seeking an experienced QA Operations Manager. This globally recognized organization is at the forefront of pharmaceutical innovation, developing life-changing medicines and maintaining the highest standards of quality and compliance in drug development and manufacturing processes.

Your Responsibilities

•  Oversee batch release operations for clinical trial materials, components, and development documentation according to established SOPs and delegated authorities 
• Lead quality oversight activities for master and executed batch records, ensuring comprehensive review and resolution of GMP documentation deficiencies 
• Develop and review critical GMP documents including Certificates of Analysis, Batch Record Review checklists, Standard Operating Procedures, and risk assessments 
• Serve as primary QA contact for assigned Contract Manufacturing Organizations, coordinating site visits, audit preparations, and CAPA follow-up activities 
• Support regulatory inspections and audits by providing expertise on assigned projects and ensuring compliance readiness
• Manage Quality Risk Assessments and coordinate feedback collection from various QA stakeholders to maintain harmonized responses 
• Provide technical guidance to QA specialists and cross-functional teams on cGMP compliance matters within the TRD environment

Your Profile

Master's degree with minimum 5 years of experience in pharmaceutical quality assurance 

Comprehensive knowledge of cGMP regulations and proven ability to analyze and evaluate compliance requirements

Technical expertise in pharmaceutical development, production processes, and quality assurance methodologies 

Strong scientific and regulatory background with experience in technical R&D environments (pharmaceutical/chemical industry preferred)

Excellent organizational and decision-making capabilities with demonstrated leadership skills • Fluent English proficiency (written and spoken); German language skills are advantageous 

Project management experience and ability to work effectively in cross-functional teams

Benefits with Nemensis

• Nemensis AG is your specialized personnel consultant in the Life Sciences sector based in Basel 
• Comprehensive consultation and support throughout the application process by our experienced consultants 
• Access to an extensive client network and exciting positions in Northwestern Switzerland 
• Fast and uncomplicated entry through individual guidance and consultation in the application process

Ready to Advance Your Quality Assurance Career?

At nemensis ag, we have already connected thousands of applicants with their dream jobs and given them the opportunity to develop further or re-enter the job market. What can we do for your career today? Contact us!

? Zak Cook, Consultant, E-Mail schreiben

"Are you looking for a career change, but this isn't the right position for you? Then register with us – we will contact you for an initial meeting to understand your wishes and needs and align ourselves accordingly."