GCP Quality Compliance Manager

Job Description

Role Overview:Join Amgens mission of serving patients by becoming a GCP Quality Compliance Manager. At Amgen, you will play a vital role in supporting the implementation, monitoring, and continuous improvement of the R&D Quality Management System (QMS) to ensure procedures and processes meet regulatory requirements. Your work will contribute to the collection, analysis, and reporting of quality metrics, as well as provide hands-on support in ensuring procedural compliance with GCP standards and other regulatory requirements across R&D.Key Responsibilities:- Assist in maintaining and improving the QMS by tracking, documenting, and implementing quality initiatives- Contribute to the collection, analysis, and reporting of quality metrics to identify trends, risks, and areas for improvement- Support the Senior Manager in ensuring procedural compliance with GCP standards and other regulatory requirements- Act as a liaison between the Process Quality function and Global Networks for collaboration and information exchange- Provide support for the Serious Breach Process and perform risk assessments- Identify data quality indicators/trends, recommend and implement corrective actions- Coordinate activities related to site/sponsor inspections and auditsQualifications Required:- Doctorate degree OR Masters degree and 2 years of Quality/Compliance/Process Management experience OR Bachelors degree and 4 years of Quality/Compliance/Process Management experience OR Associates degree and 8 years of Quality/Compliance/Process Management experience OR High school diploma / GED and 10 years of Quality/Compliance/Process Management experience- 2 years or more experience in Quality Management, Quality Assurance, or relevant areas of the pharmaceutical/biotech industry- Solid understanding of SOP/Standards management and methods/technology used in a diverse R&D environment- Thorough understanding of Clinical R&D activities and Global Regulations- Strong analytical, critical thinking, and decision-making abilities- Excellent verbal and written communication skills in EnglishAdditional Company Details:Amgens award-winning culture is collaborative, innovative, and science-based, providing a supportive environment for personal and professional growth. The organization offers a Total Rewards Plan with competitive benefits, including health and welfare plans, financial plans, work/life balance, career development opportunities, and flexible work models. Amgen fosters an inclusive environment of diverse, ethical, committed individuals dedicated to advancing science to serve patients worldwide. Role Overview:Join Amgens mission of serving patients by becoming a GCP Quality Compliance Manager. At Amgen, you will play a vital role in supporting the implementation, monitoring, and continuous improvement of the R&D Quality Management System (QMS) to ensure procedures and processes meet regulatory requirements. Your work will contribute to the collection, analysis, and reporting of quality metrics, as well as provide hands-on support in ensuring procedural compliance with GCP standards and other regulatory requirements across R&D.Key Responsibilities:- Assist in maintaining and improving the QMS by tracking, documenting, and implementing quality initiatives- Contribute to the collection, analysis, and reporting of quality metrics to identify trends, risks, and areas for improvement- Support the Senior Manager in ensuring procedural compliance with GCP standards and other regulatory requirements- Act as a liaison between the Process Quality function and Global Networks for collaboration and information exchange- Provide support for the Serious Breach Process and perform risk assessments- Identify data quality indicators/trends, recommend and implement corrective actions- Coordinate activities related to site/sponsor inspections and auditsQualifications Required:- Doctorate degree OR Masters degree and 2 years of Quality/Compliance/Process Management experience OR Bachelors degree and 4 years of Quality/Compliance/Process Management experience OR Associates degree and 8 years of Quality/Compliance/Process Management experience OR High school diploma / GED and 10 years of Quality/Compliance/Process Management experience- 2 years or more experience in Quality Management, Quality Assurance, or relevant areas of the pharmaceutical/biotech industry- Solid understanding of SOP/Standards management and methods/technology used in a diverse R&D environment- Thorough understanding of Clinical R&D activities and Global Regulations- Strong analytical, critical thinking, and decision-making abilities- Excellent verbal and written communication skills in EnglishAdditional Company Details:Amgens award-winning culture is collaborative, innovative, and science-based, providing a supportive environment for personal and professional growth. The organization offers a Total Rewards Plan with competitive benefits, includ

Keyskills :
Quality ManagementComplianceProcess ManagementAnalytical SkillsCritical ThinkingBusiness WritingVerbal CommunicationWritten CommunicationLeadership SkillsSOPStandards ManagementClinical RD ActivitiesGlobal RegulationsDecisionmaking