Quality Manager – Clinical

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QbD Group

WebsiteLinkedInAll Job Openings

501 - 1000 employees

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

QbD Group is a consulting company specializing in the life sciences sector. They provide comprehensive quality assurance and regulatory affairs services, supporting companies throughout the entire product lifecycle, from traditional pharmaceuticals to advanced therapy medicinal products. With a focus on life sciences, QbD Group offers a range of services, including quality control, qualification and validation of biotech products, and clinical solutions. They emphasize safety and regulatory compliance and offer innovative digital solutions for quality management. QbD Group distinguishes itself with its commitment to fostering innovation, providing a supportive work environment, and maintaining strong industry connections.

📋 Description

• 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.

🎯 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.