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Quality Manager (m/f/d)

ASTRUM is a leading Clinical Research Organization (CRO) providing innovative solutions for

clinical trials. Our international team of experts supports pharmaceutical and biotech

companies with a focus on quality, efficiency, and patient-centered solutions.

ASTRUM Quality & Compliance (Q&C) have an exciting opportunity for an experienced Quality

Manager to join their recently restructured, small, highly motivated and enthusiastic global

team.

The ideal candidate will enjoy solving problems, be process focused, able to use metrics to
understand performance and proactively drive changes that will enable continuous
improvement.

Responsibilities include:

• Develop quality standards, processes and procedures, and reviewing existing

processes to assess compliance with regulatory requirements and support
continuous improvement.

• Monitor and manage quality issues throughout the clinical development process to

proactively provide quality data to support improved business decisions.

• Coordinate cross-functional teams to investigate quality issues, conduct Root Cause

Analyses (RCA) and identify areas for improvement

• Collaborate with cross-functional teams to develop and implement Corrective and

Preventive Actions (CAPA) to resolve quality-related issues

• Create reports and documentation related to quality issues, proactively identify risk

areas and provide regular quality performance metrics to Global Head of Q&C

• Prepare for and support internal and external audits, including inspections by

regulatory authorities

• Proactive support continuous improvement of the Quality Management System

(QMS)

• Act as the central quality contact person for all internal and external quality-related

issues

• Creation of quality policy goals in cooperation with the Global Head of Q&C
  

Requirements:

• A degree in a relevant field (e.g., pharmacy, biology, medicine, engineering) or

equivalent qualification

• 2-5 years of experience in quality management, ideally in clinical research or a CRO
  

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• In-depth knowledge of regulatory requirements (GCP, ICH) and experience managing

quality issues

• Strong analytical skills with the ability to perform Root Cause Analyses

• Excellent communication skills and the ability to work effectively in cross-functional

teams

• Proficiency in English, spoken and written

• Self-motivated, structured, and solution-oriented approach with a strong ability to

work in a team

What we offer:

• A challenging position within a dynamic and growing company

• Opportunities for personal development and training

• An international work environment with exciting projects and renowned clients

• The option for remote work

• Competitive salary
  

Do you want to join our team? We look forward to receiving your application! Please send
your complete application (cover letter, CV, certificates) including your salary expectations
and earliest possible start date via email to:

Stephanie.May@astrumcro.com

20241118_ASTRUM_QualityManager.docx