Quality Manager – Clinical

ManagerManagerFull TimeRemoteSeniorTeam 501-1,000H1B No SponsorCompany SiteLinkedIn

Location

Belgium

Posted

35 days ago

Salary

0

Seniority

Senior

Bachelor Degree5 yrs expEnglishGoogle Cloud Platform

Job Description

Quality Manager – Clinical

QbD Group

• Your role covers the full quality lifecycle, from documentation and records management to audits, risk management, and continuous improvement. • Establish and maintain a controlled document and records management system, ensuring version control, traceability, and regulatory compliance. • Manage customer complaints and nonconforming services, including investigation, root cause analysis, corrective actions, and trend analysis. • Lead the CAPA process and ensure effective, structured root cause analysis using recognized methodologies. • Plan and conduct internal and supplier audits and act as the primary contact for inspections by regulators, certification bodies, clients, and partners. • Qualify and monitor suppliers, manage supplier performance, and oversee formal change control for quality-critical changes. • Define and monitor quality objectives and KPIs, reporting performance and driving continuous improvement in collaboration with global stakeholders. • Ensure validation and ongoing compliance of GxP-relevant and business-critical systems in cooperation with CSV specialists. • Lead risk assessments and coordinate management reviews, presenting quality performance, risks, and improvement actions. • Integrate quality considerations into business continuity planning and resilience testing. • Oversee compliant training programs, define competence requirements, and ensure ongoing evaluation and development of quality-critical roles. • Stay current with evolving regulations and industry standards, ensuring effective communication and proactive implementation of improvement.

Job Requirements

  • Bachelor or Master degree in biological or (para-) medical sciences, Life Science, Quality Management or equivalent by experience
  • Minimum 5 years of experience in a Quality Management role within the medical device, or pharmaceutical industry
  • Proven experience with implementing and maintaining a QMS compliant with GCP.
  • Experience with internal and external audits , including regulatory inspections.
  • Deep knowledge of GxP (mainly GCP), ISO 9001, ISO 13485 and applicable regulatory requirements applicable with the IVD, MD, Pharma and LifeScience industries.
  • Strong understanding of risk-based thinking and quality system integration
  • Proficiency in QMS software systems and document control tools.
  • Excellent oral and written communications skills
  • Excellent interpersonal skills, inspirational and motivational skills
  • Analytical and problem-solving skills.
  • Attention to detail and organizational skills.
  • Demonstrates integrity and ethical conduct.
  • Proactive and results-oriented mindset.
  • Demonstrates ability to make timely and well-reasoned decisions
  • Ability to maintain composure in difficult circumstances and sensitive to cultural differences
  • Open to international travel
  • Fluent in English .
  • Other languages are a plus

Benefits

  • Make a real impact: Contribute to shaping the future of the Life Sciences industry by supporting innovative projects and clients across pharma, biotech and medical devices
  • Grow within a community of experts: Benefit from knowledge-sharing, mentoring, and exposure to diverse, challenging assignments that broaden your expertise.
  • Build a meaningful career: As an ambitious and pioneering company, we want to offer you the best possible environment to thrive within the life sciences.
  • A fair, competitive package: We offer tailored, transparent compensation aligned with your expertise, preferences, and local market regulations — because your contribution deserves to be valued.

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