Global Clinical Quality Assurance Manager
Vor 4 Tagen
We are seeking a highly skilled and experienced Clinical Quality Assurance Manager to join our team at Olympus Europa SE & Co. KG. As a key member of our quality organization, you will be responsible for ensuring the highest standards of quality and compliance in our clinical operations.
Key Responsibilities- Maintain and monitor Olympus GCP processes and procedures for compliance with applicable regulations and industry best practices.
- Lead or assist with the implementation of quality process audit and inspection readiness activities to ensure clinical studies are conducted in compliance with relevant Olympus policies, procedures, regional and local regulatory requirements and global guidelines and standards.
- Lead or assist with identifying non-conformances with requirements, provide suitable recommendations and facilitate ongoing quality improvements using risk-based methodology while maintaining compliance with applicable study protocols, quality system regulations and/or ISO standards where applicable.
- Lead the development and maintenance of key clinical quality metrics for input into process improvement initiatives and/or presentation to study management teams and senior leadership.
- Lead the development and delivery of clinical-quality- and compliance-related training to internal functional groups; provide guidance internally and ensure study teams are following targeted SOPs during a study.
- Assist in development of risk-based GCP audit strategies across clinical programs and/or studies; plan, develop and manage audits of clinical vendors, clinical sites and/or internal clinical processes and associated follow-up activities (e.g., reports, corrective actions).
- Perform reviews of clinical study documentation for data integrity and compliance with GCP guidelines and regulation, including quality control checks of the eTMF to ensure it is ready for inspection.
- Assure appropriate oversight of the computer software validation program and of the vendor qualification/management program.
- Assist in conducting audits, risk assessments and inspections of clinical study vendors.
- Work with vendors and support personnel in eliminating problems via root cause analysis techniques to continuously review and improve existing processes.
- Work closely with the Olympus quality organization to support audit /inspection readiness activities and responses; driving process improvements as needed.
- BA / BSc degree in Life Sciences or related field (i.e., Biomedical Engineering).
- Long-standing experience working in clinical quality assurance/operations roles (medical device industry strongly preferred).
- Long-standing experience in medical device or pharmaceutical industry.
- Solid knowledge of ICH-GCP, applicable global clinical regulations and guidelines and quality principles (ISO 13485, ISO 14155 and ISO 14971 knowledge).
- Direct experience interacting with FDA and/or other health authority inspections of sponsor, investigator site(s) and/or CRO(s); ability to represent the company in audits, coordinating responses with legal, clinical development and outside vendors where applicable.
- Experience auditing clinical vendors, clinical research organizations (CRO) and internal clinical programs.
- Experience leading, developing and/or implementing inspection readiness programs and associated activities as well as in managing inspection and post-inspection follow-up activities.
- Skilful use of CTMS, eTMF and EDC systems.
- Experience working in a global cross-functional team (functional/matrix) environment and knowledge and/or experience working with groups with varied cultural backgrounds and learning styles required.
- Excellent written and verbal communication skills, including the ability to communicate effectively at all levels of the organization.
- Strong analytical and problem-solving skills with a focus on risk management, validation and continuous improvement.
- Availability for domestic and international travel (up to 15%) and for occasional global meetings in the morning/evening.
- Flexible working hours, remote work possible (up to 60%).
- 30 days of holidays per year.
- Modern office and inspiring working environment.
- Employee restaurant with live cooking and healthy food (subsidized).
- Public transport ticket (100% subsidized) or free parking space.
- Company sport groups and inhouse company gym.
- Employee Assistance Program to support your health, mental and emotional well-being.
- Comprehensive company pension scheme.
- Company medical officer and vaccination offers.
- Childcare through our 'Buttje & Deern' partner.
- Bike leasing.
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