Quality Compliance Manager

RESPONSIBILITIES

• GCP Subject Matter Expert - Provide independent and objective quality advice in support of clinical trial activities and in line with current best practice.
• Provide quality oversight for Amgen programmes 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
• Demonstrated ability to leverage artificial intelligence (AI) tools and technologies to streamline workflows, drive process automation, and support data-driven decision-making. Must be adept at identifying opportunities to apply AI for operational efficiency and continuous improvement initiatives.
• 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 stakeholders
• Support Monthly meetings with program level CPO senior management/associate directors to review, but not limited to, the following: on-going 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
• 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 stakeholders
• Plan, conduct and report out on risk-based Good Clinical Practices (GCP) audits (investigator site audits, affiliate audits, and study level audits)

WHAT WE EXPECT OF YOU

We are all different, yet we all use our unique contributions to serve patients. The individual we seek has technological literacy and leadership skills, and has these qualifications:

• 8-13 years of 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 stakeholder 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 .