Astrum

Menu

Open Role

Quality Manager

Portugal, Spain Apply Now
Full-timeHybridCompetitive SalaryStart date : 20.10.25End date : 20.10.25

Job Description

We are looking for an experienced Quality Manager (Q&C) to join our Quality and Compliance team.

The Quality Manager will be responsible for the day-to-day management of quality and compliance activities, supporting the Global Head of Q&C in maintaining and enhancing Astrum’s global quality standards and regulatory compliance.

Responsibilities

General

  • Work autonomously within core responsibilities to maintain compliance and quality excellence.
  • Develop, update, and review Q&C quality standards, processes, and procedures to ensure compliance with regulatory requirements.
  • Promote adherence to regulatory requirements and internal standards to ensure continuous Inspection Readiness.
  • Support the Global Head of Q&C in developing and implementing quality policy goals.
  • Provide input to regular Q&C team meetings, sharing data, presentations, and recommendations.
  • Collaborate cross-functionally across departments and interface with management and clients.

Quality Assurance

  • Prepare, conduct, and report on internal audits (vendor, technology, and process-related).
  • Conduct peer reviews of internal audit reports and oversee Corrective & Preventive Action (CAPA) Plans.
  • Support external audits and inspections by regulatory authorities.

Quality Systems

  • Oversee controlled document (CD) management and ensure alignment with Q&C training activities.
  • Manage the day-to-day operations of the eQMS (CD & Q&C modules).
  • Support continuous improvement initiatives across the Quality Management System (QMS).

Quality Issue Management

  • Monitor and manage quality issues, leading investigations and Root Cause Analyses (RCA).
  • Provide quality data reports and performance metrics to support informed business decisions.
  • Act as the main contact for internal and external quality-related matters.

Q&C Data Analytics & Reporting

  • Maintain and update Q&C data trackers.
  • Deliver regular and ad-hoc data analyses and reports.

Quality Management Training

  • Manage the Astrum training platform and training matrices.
  • Ensure completion, compliance, and maintenance of training records in the eQMS.

Responsibilities

  • Bachelor’s or Master’s degree in a relevant field (e.g., pharmacy, biology, medicine, engineering) or equivalent qualification.
  • Minimum of 3 years’ experience in quality management, ideally within clinical research or a CRO.
  • Strong understanding of GCP, ICH, and other regulatory requirements.
  • Proven ability to conduct audits, manage CAPAs, and perform Root Cause Analyses.
  • Excellent analytical, communication, and organizational skills.
  • Proficiency in English (spoken and written).
  • Skilled in standard business applications and eQMS tools (e.g., MS Office, eQMS platforms).
  • Self-motivated, structured, and solution-oriented with a strong teamwork mindset.
  • Continuous improvement mindset with the ability to identify and implement process enhancements.

What Astrum Offers

  • Flexible working hours through flextime.
  • Competitive salary.
  • Opportunities for professional growth within a supportive and dynamic team.
  • Hybrid work options and an engaging work environment.
  • A culture that values your ideas for process and quality improvement.

About Astrum

Astrum is a pan-European Contract Research Organisation (CRO) formed from leading clinical research companies across Spain, Portugal, Germany and France. We deliver end‑to‑end clinical development services, from early Phase I studies to late‑phase trials, supported by specialist expertise across an array of clinical services.

With over 25 years of combined experience and more than 300 clinical professionals across Europe, we are committed to scientific excellence, flexibility and transparency—helping our partners bring new treatments to patients faster, safer, and always with confidence.

Interested in the role?

Click the button below to apply.







    Max 5mb