Alimentiv
Senior GCP Quality & Compliance Auditor
Alimentiv, San Diego, California, United States, 92189
Senior GCP Quality & Compliance Auditor
Senior GCP Quality & Compliance Auditor
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.
Audit Planning, Execution, and Management Responsibilities
Lead and execute comprehensive quality and compliance audits in accordance with regulations and standards governing clinical research (including internal audit, vendor audit and site audit) to assess adherence to regulatory standards and company policies
Develop and implement strategic, risk-based audit plans to proactively identify areas of concern and ensure regulatory compliance
Provide expert consultation on GxP requirements and quality assurance strategies, guiding both internal and external stakeholders
Coordinate and conduct clinical sites audit in collaboration with project management teams, ensuring efficient and effective audit execution
Lead audit facilitation efforts with external auditors and regulatory authorities, ensuring thorough preparation and representation of Alimentiv
Analyze and interpret audit findings to author or direct the preparation of detailed audit reports, identifying risks, gaps, and areas for improvement
Oversee and review corrective action / preventative action (CAPA) plans, ensuring timely implementation and effectiveness in addressing non-compliance issues
Perform trend analysis on audit findings, providing data-driven insights to support continuous quality improvement initiatives
Develop and lead Alimentiv's auditor training program for Corporate Quality, ISO auditors and other Alimentiv staff by providing guidance on audit techniques, risk assessment and system approach
Organize and conduct mock inspections to prepare teams for external regulatory audits and identify potential compliance risks before formal inspections
Review and approve audit reports prepared by junior auditors, ensuring accuracy, clarity, and regulatory alignment
Stay abreast of evolving regulations and best practices related to clinical research activities to ensure the company's audit strategies remain current and effective
All employees are expected to complete training on time and maintain a minimum level of 90% training compliance at all times.
Qualifications
At minimum, qualified candidates will have :
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
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
95,500 - $159,000 a year + bonus
Work location and conditions: Home-based, Remote, regular office-hours
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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.
Audit Planning, Execution, and Management Responsibilities
Lead and execute comprehensive quality and compliance audits in accordance with regulations and standards governing clinical research (including internal audit, vendor audit and site audit) to assess adherence to regulatory standards and company policies
Develop and implement strategic, risk-based audit plans to proactively identify areas of concern and ensure regulatory compliance
Provide expert consultation on GxP requirements and quality assurance strategies, guiding both internal and external stakeholders
Coordinate and conduct clinical sites audit in collaboration with project management teams, ensuring efficient and effective audit execution
Lead audit facilitation efforts with external auditors and regulatory authorities, ensuring thorough preparation and representation of Alimentiv
Analyze and interpret audit findings to author or direct the preparation of detailed audit reports, identifying risks, gaps, and areas for improvement
Oversee and review corrective action / preventative action (CAPA) plans, ensuring timely implementation and effectiveness in addressing non-compliance issues
Perform trend analysis on audit findings, providing data-driven insights to support continuous quality improvement initiatives
Develop and lead Alimentiv's auditor training program for Corporate Quality, ISO auditors and other Alimentiv staff by providing guidance on audit techniques, risk assessment and system approach
Organize and conduct mock inspections to prepare teams for external regulatory audits and identify potential compliance risks before formal inspections
Review and approve audit reports prepared by junior auditors, ensuring accuracy, clarity, and regulatory alignment
Stay abreast of evolving regulations and best practices related to clinical research activities to ensure the company's audit strategies remain current and effective
All employees are expected to complete training on time and maintain a minimum level of 90% training compliance at all times.
Qualifications
At minimum, qualified candidates will have :
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
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
95,500 - $159,000 a year + bonus
Work location and conditions: Home-based, Remote, regular office-hours
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