Global Clinical Quality Assurance Manager (m/f/d)

at  Olympus Europa SE Co KG OEKG

Your responsibilities

• Maintain, and monitor Olympus GCP processes and procedures for compliance with applicable regulations and industry best practices, participate in clinical process improvement projects and initiatives for development, enhancement and implementation of controlled documents (e.g. SOPs, Work Instructions, Templates)
• Lead or assist with the implementation of Quality processes 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 or contribute to 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 inspection ready
• Assure appropriate oversight of the Computer Software Validation program
• Assure appropriate oversight 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
• Other duties as assigned

Your qualification

• Required: BA/BS degree in life sciences or related field (i.e., Biomedical Engineering)
• 7+ years of experience working in clinical quality assurance/operations roles (medical device industry strongly preferred)
• 10+ years’ experience in medical device or pharmaceutical industry
• Solid knowledge of ICH-GCP, applicable global clinical regulations and guidelines, and quality principals (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. Experience in managing inspection and post-inspection follow-up activities
• 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 is 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
• Previous experience of CTMS, eTMF and EDC Systems
• Domestic and international travel up to 15%
• Availability in the morning/evening for global meetings (occasionally)

Your benefits

• Flexible working hours, remote work possible (up to 60%)
• 30 days of holidays per year
• Modern office and an 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 an inhouse company gym
• Employee Assistance Program to support your health, mental and emotional well-being
• A comprehensive company pension scheme
• Company medical officer and vaccination offers
• Childcare through our ‘Buttje&Deern’ partner
• Bike leasing

• Maintain, and monitor Olympus GCP processes and procedures for compliance with applicable regulations and industry best practices, participate in clinical process improvement projects and initiatives for development, enhancement and implementation of controlled documents (e.g. SOPs, Work Instructions, Templates)
• Lead or assist with the implementation of Quality processes 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 or contribute to 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 inspection ready
• Assure appropriate oversight of the Computer Software Validation program
• Assure appropriate oversight 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
• Other duties as assigne