Looking for a Quality Manager to implement and oversee quality in a regulatory environment! The Quality Manger will facilitate compliance with the creation and guidance of standard operating procedures; managing PCM TRIALS quality operations, audits, and processes.
Review and revise quality program for constant improvement.
Execute and maintain quality management system.
Develop and manage Standard Operating Procedures (SOPs) and monitor compliance with them.
Lead or assist activities in the areas of Internal Quality Audits, CAPA (Corrective and Preventive Actions), Quality Management Reviews, and Quality Audits.
Develop and maintain GCP/ICH compliant processes which control the quality of work.
Facilitate/manage hosting 3rd-party audits of PCM TRIALS.
Assess, monitor and audit vendors.
Assist in providing training to PCM TRIALS staff.
Support special projects requiring quality input.
Perform other related duties as assigned.
3+ years working in a Quality Control / Assurance area.
Bachelor’s degree from an accredited four-year college or university.
Experience creating and managing quality processes in a clinical research organization.
3 years in the Pharmaceutical Industry and or Medical Device Industry with an indepth knowledge of regulatory standards, and Good Clinical Practice for the conduct of clinical trials or equivalent.
Excellent verbal and written communication skills and strong interpersonal skills.
Ability to administer, supervise and coordinate multiple projects and work autonomously.
Strong skills in Microsoft Office products.
Travel 0-10% of the time.
About PCM TRIALS
PCM TRIALS provides patients enrolled in clinical trials with assessments done in their home or office. We utilize a network of directly employed Certified Mobile Research Nurses to visit subjects around the world, providing services for over 100 pharmaceutical and biotech companies. Our Denver office is growing and looking for individuals who are interested in working in a fast paced start-up environment!