Quality Compliance Manager

Description

• GCP Subject Matter Expert - Provide independent and objective quality advice in support of clinical trial activities and in line with current standard methodology.
• Provide quality oversight for Amgen programs for all stages of products in clinical development
• Ensure quality oversight for the Risk Assessment Categorization Tool (RACT) for each trial to guarantee the proper identification, prioritization, and mitigation of risks to critical data and processes and patient safety, welfare and rights
• Support the establishment of regional expertise to ensure quality and compliance to local Regulations
• Support Clinical Trial Teams for all quality management activities, including Deviations/CAPAs, Inspection Readiness and Management activities, and Serious Breaches/ Privacy Issues
• Ensure TA-specific data integrity, including technologies for data collection and measurement (e.g., biomarker usage and imaging methods)
• Review clinical trial protocols ensuring simplification, application of lessons learned, and identification of critical data and processes
• Actively seek and implement innovative and proactive quality oversight methodologies (e.g., risk-methods leveraging AI and Natural Language Processing, and other advanced data analytics methods)
• Manage/support regulatory inspection and review responses.
• Prepare, analyze and Identify data quality indicators/trends, identify areas of weakness/gaps, recommend and implement corrective actions and communicate quality metrics and other significant quality information on periodic basis to key partners
• Support Monthly meetings with program level CPO senior management/associate directors to review, but not limited to, the following: ongoing quality issues, quality trends, program filing timelines and potential inspections.
• Support response generation for audit findings and self reported deviations.
• Support the establishment of regional expertise to ensure quality and compliance to local regulations
• Provide Study Specific Vendor Quality Oversight
• Plan, conduct and report out on risk-based Good Clinical Practices (GCP) audits (investigator site audits, affiliate audits, and study level audits)

Qualifications

• Doctorate degree OR
• Master’s degree and 2 years of quality management experience OR
• Bachelor’s degree and 4 years of quality management experience OR
• Associate’s degree and 8 years of quality management experience OR
• High school diploma / GED and 10 years of quality management experience

Preferred Qualifications:

• Experience in Quality Management, Quality Assurance or other relevant areas of the pharmaceutical/biotech industry where risk-based quality and quality by design are a core responsibility
• Oversight and implementation of Quality Management Systems and experience managing quality in electronic QMS such as Veeva or Track wise.
• Thorough understanding of Clinical R&D activities and Global Regulations.
• Knowledge of the Regulatory Submission and Inspection Management procedures.
• Quality Oversight of Clinical Trials, including clinical trial protocol development, execution, and submissions.
• Excellent verbal and written communication skills, including strong business writing abilities and active listening.
• Ability to transform business and team member feedback into clear, efficient processes using a straightforward language and format.
• Strong analytical, critical-thinking, and decision-making abilities.
• Capability to understand and articulate technical concepts and literature in spoken and written English.