QA Validation Manager / QA Validation Manageress

Join Our Client as a QA Validation Manager

Take on a pivotal role in maintaining top-tier quality standards! If you possess a keen eye for detail and a strong passion for compliance, this could be the perfect opportunity for you.

Proclinical is seeking a QA Validation Manager to oversee and ensure compliance with critical GMP processes, aligning with product requirements, process parameters, and global regulatory guidelines. In this role, you will closely collaborate with cross-functional teams, manufacturing, and clients to provide scientifically sound evidence that supports sustainable product quality.

You will serve as a key QA point of contact for validation projects, product transfers, and validation strategies while supporting compliance throughout the product lifecycle.

Responsibilities

• Ensure critical GMP processes are validated and maintained in compliance with regulatory guidelines and product requirements.
• Oversee validation activities for biotechnological manufacturing processes in low bioburden environments.
• Support validation of manual and automated cleaning and sanitization processes.
• Manage qualification requirements for related equipment and systems.
• Lead continuous process verification (CPV) and process validation activities.
• Act as a QA point of contact for product transfer activities and validation strategies.
• Perform change control and deviation impact assessments.
• Support investigations of non-conformities and ensure resolution.
• Review and approve SOPs, protocols, reports, change controls, deviations, and other GMP records.
• Participate in audits and inspections to demonstrate compliance with European and US FDA regulations.
• Contribute to continuous improvement initiatives.
• Serve as a subject matter expert (SME) for Process Validation and Cleaning Validation SOPs.
• Review and approve validation documentation, including Process Validation, Cleaning Validation, and Computer System Validation (CSV).
• Participate in risk assessments and support the Data Integrity Program.

Key Skills and Requirements

• Degree in Science, Biotechnology, or a related field.
• Strong knowledge of process validation, cleaning validation, and equipment/system qualification.
• Experience with change controls, deviation management, and non-conformity investigations.
• Understanding of cell and gene manufacturing processes and low bioburden environments.
• Proficiency in English; knowledge of the German language is a plus.

If you are interested in 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 dedicated to connecting exceptional talent with prestigious positions globally. Proclinical is acting as an Employment Agency in relation to this vacancy.

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