Clinical Trials (m/w/d)

Manager QA Clinical Trials (m/f/d)

Your Responsibilities:

• Monitor compliance with quality documents in clinical areas, anticipate gaps, propose solutions, and ensure implementation of regional and local quality plans. Track corrective actions.
• Develop and maintain quality documents and resources. Ensure clear responsibilities for quality requirements. Recommend updates and advise on necessary training.
• Lead audit and inspection preparations, organize documentation, and conduct pre-inspection visits. Ensure timely completion of corrective action plans.
• Act as a quality consultant, strengthen quality controls, and share best practices. Collaborate with other quality groups and support key projects.
• Provide expert advice on regulatory requirements and quality standards. Manage deviations, change controls, and support CAPA processes and risk assessments.
• Drive process improvement initiatives, review quality metrics to identify weaknesses, and recommend corrective actions. Monitor completion of deviations, change controls, CAPAs, and audit responses.

Your Profile:

• Bachelor's degree in life sciences, technology, healthcare, or equivalent experience. Experience applying quality systems in clinical trial management, preferably in quality assurance.
• Ability to manage multiple projects and tasks, prioritize work, and meet deadlines. Strong organizational and self-management skills.
• Excellent written and verbal communication skills. Ability to influence stakeholders and foster collaboration in diverse teams.
• Strong problem-solving, critical thinking, and analytical skills. Attention to detail and verbal reasoning skills to evaluate quality data and drive improvements.
• Proven interpersonal skills and flexibility to work in various cultural and geographic environments. Ability to work independently and in global teams.
• Experience in a global quality assurance environment is desirable. Knowledge of quality systems, regulatory requirements, and clinical trial processes.

Interested?
Send your application (CV, certificates, references) via the application link or by email to l.kramer[at]progressive.de.
If this position is not suitable for you, please share it within your network. Referrals are welcome!

Dieser Geschäftszweig der SThree GmbH betreut die ausgeschriebene Stelle im Auftrag ihres Kunden.