Quality Assurance Manager
6 dagen geleden
QPS Netherlands B.V. in Groningen is part of an international organization and conducts drug research on behalf of international pharmaceutical and biotechnological companies.
We are seeking an experienced Quality Assurance Manager to lead our Quality Assurance (QA) operations, ensuring full compliance with GLP, GCPand limited GMP standards, especially in the testing of pharmaceuticals. This is a key leadership position requiring a strong background in audit management, team oversight, and strategic quality initiatives.
Key Responsibilities:
- Audit Management: Lead and coordinate a range of internal and external audits, including client, sponsor, and third-party audits. Ensure compliance with national and international regulatory requirements and help resolve issues swiftly and effectively.
- Quality Management System (QMS): Oversee the development and execution of the QMS, ensuring regulated processes, systems, and facilities comply with industry standards. Support Test Site and Test Facility management in maintaining operational and ethical excellence.
- Compliance & Improvement: Stay updated on regulatory changes and help implement quality improvement initiatives to ensure continuous compliance. Partner with operational teams to manage corrective actions (CAPA) and drive quality improvements. Ensure full compliance with local and international regulations, particularly adhering to the standards set by the Dutch Inspectorate.
- Team Leadership: Manage and allocate QA staff, assign work, and conduct performance evaluations. Ensure training, development, and mentoring/coaching to maintain high team performance.
- Reporting & Metrics: Prepare monthly quality reports, track KPIs, and oversee the use of metrics to measure quality performance. Support budgeting and resource allocation for the QA department.
- GMP Focus: Oversee limited GMP-related activities, including validation, handling complaints, and ensuring the ongoing validation of production processes.
Requirements:
- Overall Experience: 10+ years of experience preferred in a pharmaceuticals-related regulated industry, with at least 5 years in audit-related roles. Familiarity with clinical and preclinical services, and validation processes for systems and production.
- Audit Expertise: At least 5 years of experience in audit management within a regulated environment (GMP, GLP, GCP), with a solid understanding of quality systems, data integrity, and regulatory compliance.
- Regulatory Knowledge: Strong knowledge of QA's role in a GLP, GCP and GMP environment as related to pharmaceutical testing and compliance, including Dutch Regulatory Compliance.
- Leadership Experience: Demonstrated ability to lead and mentor a team, manage resources, and conduct employee performance evaluations.
- Soft Skills: Excellent communication, presentation, and strategic thinking skills. You are resilient, patient, and capable of handling complex quality issues with a proactive approach.
- Organizational Skills: Ability to handle multiple priorities and maintain high attention to detail, especially in administrative tasks, budgeting, and work allocation.
- Education: University degree in a scientific discipline (e.g., biology, chemistry, biochemistry).
About QPS: This is an opportunity to take on a pivotal role in a leading organization where your leadership will shape our quality assurance efforts. If you're ready to bring your expertise to a dynamic team that values innovation and quality, we would love to hear from you.
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