Clinical Quality Assurance Manager

Working Location: PENNSYLVANIA, CENTER VALLEY; MASSACHUSETTS, WESTBOROUGH; MINNESOTA, BROOKLYN PARK 

Workplace Flexibility: Hybrid

 

For more than 100 years, Olympus has focused on making people’s lives healthier, safer and more fulfilling. ​​

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Every day, we live by our philosophy, True to Life, by advancing medical technologies and elevating the standard of patient care so people everywhere can fulfill their desires, dreams, and lives.

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Our five Core Values empower us to achieve Our Purpose: 

 

Patient Focus, Integrity, Innovation, Impact and Empathy. 

 

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Job Description

The Clinical Quality Assurance Manager reports directly to the Executive Director of Clinical Quality Assurance and provides support to ensure the quality and compliance of studies conducted throughout Olympus.   This role will involve working cross functionally with internal and external stakeholders in support of CQA initiatives to ensure continuous improvement and quality in adherence to agency regulations and standards, GCP, Industry guidelines, and Olympus policies and processes for the conduct of clinical studies.  

Job Duties

• 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.

Job Qualifications

Required:

• BA/BS degree in life sciences or related field (i.e., Biomedical Engineering)