QA Expert / QA Expertess

Join Our Team as a Senior QA Expert for QC

Become the driving force behind seamless logistics for a global CMO, where precision and efficiency are paramount in supporting world-class manufacturing. Proclinical is seeking a Senior QA Expert for Quality Control (QC) to provide quality oversight and support across microbiology projects and departmental initiatives.

In this role, you will be responsible for ensuring compliance with GMP requirements, reviewing, and approving microbiology-related batch documentation, and supporting the implementation of laboratory execution systems. By collaborating closely with cross-functional teams, you will help drive quality excellence while contributing to site objectives and broader strategic priorities.

Key Responsibilities

• Collaborate with cross-functional teams to support growth projects aligned with site quality objectives.
• Ensure project timelines and deliverables under QA-QC responsibility are met.
• Provide guidance and quality oversight for Quality Control (QC) activities.
• Act as the primary QA contact for implementing gLIMS laboratory execution systems.
• Represent QA in guiding the QC department to meet GMP requirements and follow SOPs.
• Review and approve GMP-relevant documents from QC, including SOPs focused on gLIMS implementation.
• Supervise and execute GMP compliance activities such as change requests, document management, and non-conformities.
• Write or revise SOPs within your area of expertise and manage ownership of these documents.
• Support QA in QC raw data review as needed.
• Ensure adherence to internal and external quality and safety guidelines, including regulatory GMP standards and health authority guidance.
• Manage and report KPIs related to quality assurance activities.
• Perform and support inspections and audits as required.
• Undertake additional duties as assigned.

Key Skills and Requirements

• Strong experience implementing laboratory systems within a quality-driven environment.
• Good working knowledge of clinical regulations, including US, European, and Japanese Pharmacopoeia requirements.
• Proven expertise in the qualification and validation of laboratory equipment and software systems.
• Experience liaising with regulatory authorities, including the FDA and Swissmedic.
• Highly organized with a structured and detail-oriented approach to work.
• Adaptable and proactive, with an open-minded and solution-focused mindset.
• Fluent in English; German language skills are considered an advantage.
• Project management certification, such as Green Belt or Black Belt, would be beneficial.

If you are interested in applying for this exciting opportunity, please Apply online using the form below. Only applications matching the job profile will be considered.

Proclinical is a leading life sciences recruiter focused on matching exceptional talent with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.

By submitting this application, you confirm that you've read and understood our privacy policy, which informs you how we process and safeguard your data: Privacy Policy.