Senior Quality Operations Manager

hace 19 horas

Ciudad de México, Ciudad de México Amgen SA A tiempo completo

About Amgen

At Amgen, our mission is to serve patients by delivering innovative therapies that address unmet medical needs. We are a global biotechnology leader with a commitment to making a meaningful impact on people's lives.

About the Role

We are seeking a Senior Quality Operations Manager to join our team. This role will be responsible for providing quality oversight and management of critical data and processes for global and local study teams and all clinical trial sites who participate in Amgen sponsored trials.

Main Responsibilities

  • Serve as a GCP Subject Matter Expert, providing independent and objective quality advice in support of clinical trial activities and in line with current standard process.
  • Provide quality oversight for Amgen programs for all stages of products in clinical development.
  • Plan, conduct and report out on risk-based GCP audits (investigator site audits, affiliate audits, service provider audits, and study level audits) or support outsourced audits.
  • Manage/support regulatory inspections and provide guidance and feedback on responses to health authorities, including root cause and CAPA plans.
  • Provide quality oversight for the Risk Assessment Categorization Tool (RACT) for each trial to ensure the proper identification, prioritization, and mitigation of risks to critical data and processes and patient safety, welfare, and rights.
  • Support monthly meetings with clinical program level leaders to review quality and compliance related risks, including but not limited to: on-going quality issues/deviations, quality trends, program filing timelines, potential inspections, and risks related to other programs.
  • Support response generation for audit findings and self-reported deviations.
  • Support the establishment of regional expertise to ensure quality and compliance to local regulations.
  • Conduct new vendor qualifications/evaluations in a risk-based manner.
  • 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 collaborators.
  • Support TA-specific oversight of key technologies, including technologies for endpoint data collection and measurement (e.g., biomarker usage and imaging methods).
  • Support the development of TA-specific Quality Assurance plans that are risk based and efficient. This includes protocol specific audit plans, and the execution of audits using various methods (e.g., remote, or on-site).
  • Support Clinical Trial Teams for all quality management activities, including management of quality events (e.g., Deviations/CAPAs, Serious Breaches/Privacy Issues, Inspection Readiness activities, and Inspection Management).
  • Actively seek and implement innovative and proactive quality oversight methodologies (e.g., risk-based, data analytics that may leverage AI and Natural Language Processing, or other statistically based methods).
  • Review clinical trial protocols ensuring simplification, application of lessons learned, and identification of critical data and processes for risk management activities.

Requirements

  • Doctorate degree and 2 years of quality experience OR Master's degree and 6 years of quality experience OR Bachelor's degree and 8 quality experience OR Associate's degree and 10 years of quality experience OR High school diploma / GED and 12 years of quality experience
  • A minimum of 2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources

Preferred Qualifications

  • 7 years or more experience in Quality Management, Quality Assurance, or other relevant areas of the pharmaceutical/biotech industry where risk-based quality management and quality by design are a core responsibility
  • Leadership or mentoring experience
  • 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
  • Experience with 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 customer 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

Benefits

We offer a comprehensive Total Rewards Plan, including:

  • Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
  • A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan.
  • Stock-based long-term incentives.
  • Award-winning time-off plans and bi-annual company-wide shutdowns.
  • Flexible work models, including remote work arrangements, where possible.

About Amgen SA

Amgen SA is an Equal Opportunity employer and welcomes applicants from diverse backgrounds. We believe that diversity drives innovation and we strive to create an inclusive workplace where everyone feels valued and empowered to succeed.

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