Aktuelle Jobs im Zusammenhang mit Global Clinical Quality Assurance Lead - Hamburg, Hamburg - Olympus
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Global Clinical Quality Assurance Director
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Global Clinical Quality Assurance Director
vor 4 Wochen
Hamburg, Hamburg, Deutschland Olympus VollzeitJob SummaryWe are seeking a highly skilled Global Clinical Quality Assurance Manager to join our team at Olympus. As a key member of our Quality organization, you will be responsible for ensuring the quality and compliance of our clinical studies and products.Key ResponsibilitiesMaintain and monitor Olympus GCP processes and procedures for compliance with...
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Global Clinical Quality Assurance Director
vor 1 Woche
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Global Clinical Quality Assurance Director
vor 2 Wochen
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Head of Quality Assurance
vor 4 Wochen
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Quality Assurance Specialist
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Quality Assurance Specialist
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Quality Assurance Specialist
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Head of Quality Assurance Director
vor 4 Wochen
Hamburg, Hamburg, Deutschland SciPro VollzeitJob Summary:The Head of Quality Assurance will lead the Quality Assurance and Quality Control functions at the Hamburg facility, ensuring compliance with all regulatory and industry standards. This role involves developing quality strategies, managing audits, and fostering a culture of continuous improvement.Key Responsibilities:Leadership & Strategy:Develop...
Global Clinical Quality Assurance Lead
vor 3 Monaten
Key Responsibilities
- Oversee and ensure Olympus GCP processes and protocols align with relevant regulations and industry standards. Engage in initiatives aimed at enhancing clinical processes and developing controlled documents such as SOPs and Work Instructions.
- Spearhead or support the execution of quality assurance audits and readiness activities to guarantee that clinical trials adhere to Olympus policies, regional regulations, and global standards.
- Identify and address non-compliance issues, offering actionable recommendations to foster continuous quality enhancements through a risk-based approach while ensuring adherence to study protocols and applicable regulations.
- Develop and maintain essential Clinical Quality metrics to inform process improvement initiatives and present findings to Study Management Teams and Senior Leadership.
- Design and deliver training on clinical quality and compliance for internal teams, ensuring adherence to established SOPs throughout the study lifecycle.
- Assist in formulating risk-based GCP audit strategies across clinical programs. Plan and manage audits of clinical vendors, sites, and internal processes, including follow-up actions such as reports and corrective measures.
- Conduct thorough reviews of clinical study documentation to ensure data integrity and compliance with GCP guidelines, including Quality Control checks of the eTMF for inspection readiness.
- Ensure proper oversight of the Computer Software Validation program and the Vendor Qualification/Management program.
- Collaborate with vendors and internal teams to resolve issues through root cause analysis, continuously improving existing processes.
- Work closely with the Olympus Quality organization to support audit and inspection readiness initiatives, driving necessary process improvements.
- Perform additional duties as assigned.
Qualifications
- Required: BA/BS degree in life sciences or a related field (e.g., Biomedical Engineering).
- Minimum of 7 years of experience in clinical quality assurance or operations roles, preferably within the medical device sector.
- At least 10 years of experience in the medical device or pharmaceutical industry.
- Comprehensive knowledge of ICH-GCP, global clinical regulations, and quality principles (ISO 13485, ISO 14155, ISO 14971).
- Direct experience with FDA and other health authority inspections of sponsors, investigator sites, and CROs, with the ability to represent the organization during audits.
- Proven experience auditing clinical vendors, CROs, and internal clinical programs.
- Experience in leading and implementing Inspection Readiness Programs and managing follow-up activities post-inspection.
- Experience working in a global, cross-functional team environment, with an understanding of diverse cultural backgrounds and learning styles.
- Exceptional written and verbal communication skills, capable of effective communication across all organizational levels.
- Strong analytical and problem-solving abilities, with a focus on risk management and continuous improvement.
- Familiarity with CTMS, eTMF, and EDC Systems.
- Willingness to travel domestically and internationally up to 15%.
- Availability for morning/evening meetings to accommodate global collaboration.
Benefits
- Flexible working hours with the option for remote work (up to 60%).
- 30 days of annual leave.
- A modern office environment that inspires productivity.
- On-site employee restaurant offering healthy meals (subsidized).
- Fully subsidized public transport ticket or complimentary parking.
- Opportunities for company-sponsored sports activities and access to an in-house gym.
- Employee Assistance Program focused on health and well-being.
- Comprehensive company pension plan.
- Access to a company medical officer and vaccination programs.
- Childcare support through a partner program.
- Bike leasing options available.
