Alimentiv
Alimentiv is a specialty contract research organization focused on gastrointestinal (GI) and liver diseases. With over 30 years of experience, Alimentiv offers a comprehensive range of clinical research and imaging services, including clinical trial management, site management, regulatory affairs, and precision medicine. The company is at the forefront of medical research and development, providing state-of-the-art imaging solutions and actionable biomarker insights. Alimentiv supports the development of GI compounds and is active in more than 60 countries, working with a network of medical and operational experts to accelerate clinical trials and patient recruitment.
Clinical Trials Design • Planning • Safety Management • Custom Services • Study Management
Senior Quality and Compliance Auditor
March 18
🏄 California – Remote
⛰️ Colorado – Remote
+9 more states
💵 $95.5k - $159k / year
⏰ Full Time
🟠 Senior
🔎 Auditor
Alimentiv
Alimentiv is a specialty contract research organization focused on gastrointestinal (GI) and liver diseases. With over 30 years of experience, Alimentiv offers a comprehensive range of clinical research and imaging services, including clinical trial management, site management, regulatory affairs, and precision medicine. The company is at the forefront of medical research and development, providing state-of-the-art imaging solutions and actionable biomarker insights. Alimentiv supports the development of GI compounds and is active in more than 60 countries, working with a network of medical and operational experts to accelerate clinical trials and patient recruitment.
Clinical Trials Design • Planning • Safety Management • Custom Services • Study Management
📋 Description
• As a technical expert in quality and compliance, the Senior Quality & Compliance Auditor plays a critical role in ensuring adherence to company policies, study protocols, GxP guidelines, and global regulatory requirements governing clinical research activities. • This position requires a deep understanding of regulatory frameworks and risk-based auditing methodologies to drive compliance, enhance quality standards, and mitigate organizational risks.
🎯 Requirements
• Education: Honor's Bachelor (minimum) • Experience: 7-9 Years in Quality auditing function in a contract research organization (CRO), pharmaceutical, biotechnology, or related organization • Understanding compliance and risk management issues relating to clinical research, and strong understanding of research ethics and privacy • Previous experience leading a team is required • Strongly Preferred: Certified Auditor (ASQ, ISO, or equivalent) • Expertise in regulations and standards governing clinical research including ICH GCP, ISO 19011, EMA Guideline on Computerized Systems and Data Integrity in Clinical Trials, etc. • Advanced technical knowledge in global regulations and industry standards as they apply to clinical research, medical devices and pharmaceuticals and in the conduct of clinical study operations • Knowledgeable of medical imaging and clinical research industry regulations and standards • Experience working and collaborating in a cross-functional global team environment • Excellent verbal and written communication skills required to draft and author written documents/reports/presentations • Strong interpersonal, verbal and written communication skills including effective listening, facilitating group discussions, influencing without authority and providing appropriate feedback • Ability to plan, organize, prioritize and manage workload independently • Adaptable to changing environments, able to think quickly, able to deal with ambiguity and learn new tasks applying routine knowledge • Superior analytical skills focusing on identifying potential compliance issues, investigating root causes, brainstorming and identifying alternatives and assessing the effectiveness of actions • Proven skills in interpreting, synthesizing, inferring, evaluating and extracting pertinent data to identify areas of risk, trends and aggregated issues
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