Quality Compliance Manager, GCP

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September 27

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Amgen

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Biotechnology • Pharmaceuticals • Science

Amgen is a global leader in biotechnology, focusing on the development and commercialization of innovative medicines made from living cells. The company aims to treat serious illnesses, often targeting diseases with limited therapeutic options. Amgen emphasizes scientific innovation and is committed to ethical research, patient safety, and environmental sustainability. It actively engages in clinical trials and is known for its contributions to the fields of cancer treatment and obesity management among others.

10,000+ employees

Founded 1980

🧬 Biotechnology

💊 Pharmaceuticals

🔬 Science

💰 $28.5G Post-IPO Debt on 2022-12

📋 Description

• Assist in the implementation, monitoring, and continuous improvement of Amgen’s R&D Quality Management System (QMS) and Regional Quality Oversight • Track, document, and implement quality initiatives ensuring procedures and processes meet regulatory requirements • Contribute to collection, analysis, and reporting of quality metrics (KPIs, KQIs) to identify trends, risks, and improvement areas • Provide hands-on support to ensure procedural compliance with GCP standards and other regulatory requirements across R&D • Act as liaison between the Process Quality function and Global Networks to support collaboration and information exchange • Provide quality oversight primarily for key target sites • Perform focused readiness checks of clinical trials remote and onsite • Perform risk assessments to support identification of sites for audits • Identify data quality indicators/trends, identify areas of weakness/gaps, recommend and implement corrective actions • Coordinate activities related to site/sponsor inspections and audits including preparation, conduct, close out and response generation

🎯 Requirements

• Doctorate degree OR Master’s degree and 2 years of Quality/Compliance/Process Management experience OR Bachelor’s degree and 4 years of Quality/Compliance/Process Management experience OR Associate’s 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 other relevant areas of the pharmaceutical/biotech industry where risk-based quality management and quality by design are a core responsibility (preferred) • Solid understanding of SOP/Standards management and methods/technology used to drive knowledge management across a diverse R&D environment • Thorough understanding of Clinical R&D activities and Global Regulations • Strong analytical, critical thinking, and decision-making abilities • Experience with process monitoring, including applying analytical methods and modern technology to enable signal detection and quality improvement • Proven team player with ability to take direction, learn rapidly, make rapid decisions and communicate them promptly • Excellent verbal and written communication skills and strong business writing abilities • Capability to understand and articulate technical concepts and literature in spoken and written English • Acts as a technical expert in GCP; strong attention to detail and proficiency in managing data and reports

🏖️ Benefits

• A 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 • Flexible work models, including remote and hybrid work arrangements, where possible • Total Rewards Plan with health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities • Career development opportunities