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Job #02954

About our client Our client is a biopharmaceutical company based in Westminster, Colorado. They focus on the development and commercialization of small molecule therapeutics for the treatment of cancer. Their team is dedicated to patients and the customers they serve. They want to attract, develop and retain world-class talent to build a high-performance organization. This is a great opportunity for the right candidate! Position Location Quality Assurance Manager Westminster, Colorado Salary Highly competitive package, commensurate with experience Responsibilities 1) Plan and conduct audits (internal and external) to ensure clinical research is conducted as per internal, domestic as well as international requirements 2) Collaborate with the Associate Director, CQA and Director as well as QA Department to conduct company-wide risk assessment and QA plan 3) Plan and conduct GCP audits (internal and external) to ensure clinical research is in compliance with applicable regulations 4) Conduct QA audits and reviews to ensure compliance with SOPs, clinical-trial protocols, federal regulations as well as GCP guidelines 5) Ensure audit results are formally and consistently recorded as well as communicated to management 6) Recommend corrective actions 7) Prepare company and clinical sites for regulatory authority inspections 8) Contribute to strategic clinical QA planning and risk assessment 9) Participate in vendor selection and qualification 10) Review and develop SOPs and working practices to ensure consistency as well as compliance with regulatory and internal standards Requirements 1) BS/BA in a Healthcare or Life Science-related field 2) 5 years in pharmaceutical/GCP-regulated environment 3) 3+ years of relevant clinical QA experience 4) International experience a plus 5) In-depth understanding of GCP guidelines, federal regulations and clinical trial process