QA Project Manager (m/w/d)

About Techfirm Engineering
Techfirm Engineering supports leading life sciences companies across Switzerland with specialized engineering expertise. Our teams deliver on-site solutions for complex technical challenges in biopharma environments.

Your Mission
As QA Project Manager, you will play a central role in ensuring quality oversight and compliance across customer projects and the overall Quality Management System (QMS). You will act as the key interface between customers, internal project teams, and health authorities, ensuring that all activities meet GMP and regulatory expectations.

Key Responsibilities
• Act as the primary QA representative for customer projects, managing all quality-related aspects and providing expert technical input throughout all project phases.
• Plan, coordinate, and host health authority inspections (e.g. FDA, Swissmedic), customer audits, and internal self-inspections.
• Serve as primary contact during inspections, managing inspector interactions, and ensuring smooth on-site audit execution.
• Lead and support Quality Risk Management (QRM) activities according to ICH Q9, including risk assessments, mitigation plans, and maintenance of the site risk register.
• Drive QMS implementation, maintenance, and continuous improvement of core quality processes (Deviations, CAPAs, Change Control, Document Management, Training).
• Manage and track CAPA plans, including cross-functional coordination and timely follow-up of commitments to authorities and customers.
• Lead inspection readiness programs and ensure audit preparedness across all departments.
• Review and approve quality documentation such as SOPs, Master Batch Records, specifications, sampling plans, and quality agreements.
• Oversee the execution and review of batch documentation, including issuance of batch records and technical review of batch data for compliance and completeness.
• Provide QA support for analytical method transfers and qualification/validation activities in collaboration with other technical disciplines.
• Contribute to regulatory submissions and provide technical QA expertise supporting customer product registration and lifecycle activities.
• Act as SME (Subject Matter Expert) during audits and inspections, representing the QA function for project-specific and product-related discussions.

Your Profile
• Degree in Life Sciences, Pharmacy, Chemistry, or equivalent.
• Several years of experience in QA roles within GMP-regulated pharmaceutical or biotech environments, ideally in aseptic manufacturing or sterile drug product development.
• Strong understanding of QMS, QRM, and GMP principles (EU, FDA, and ICH Q9).
• Proven experience in preparing for and managing inspections and audits.
• Ability to manage multiple projects simultaneously while maintaining focus on quality and timely delivery.
• Excellent communication skills in English (German is an advantage).
• Proactive mindset with strong analytical and problem-solving capabilities.

Why Work with Techfirm Engineering

• Opportunity to gain hands-on experience with an international industrial leader.
• Supportive team environment focused on professional growth.
• Dynamic, people-oriented company culture.

Interested?
If you are eager to learn and ready to take on new engineering challenges, we look forward to your application.