Senior Associate, Quality Compliance

🔥 2 minutes ago

🇺🇸 United States – Remote

💵 $89.2k - $120.6k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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Amgen

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1980

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

💰 $28.5G Post-IPO Debt on 2022-12

Healthcare • Biotechnology • Pharmaceuticals

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.

📋 Description

• Strengthen and advance Amgen’s R&D Quality Management System (QMS) • Provide quality support for Amgen programs at all stages of products in clinical development • Input audit responses into QMS • Input site inspection data into the Inspection Management System • Work with deviation owners to ensure timely development and closure of CAPAs • Ensure timely preparation and submission of documentation to the Potentially Reportable Serious Breach committee • Collaborate with Clinical Study Teams to facilitate communication • Prepare weekly metric reports for the General Medicine team, highlighting overdue items and supporting timely closure • Assess the effectiveness of metric reports and optimize them with the data quality analytics team • Facilitate Rare Disease team meetings, including agenda and presentation preparation • Maintain Decision & Action logs and Q&A logs, and follow up with action owners until resolution • Support inspection readiness activities • Provide quality oversight of small clinical programs • Leverage AI tools and technologies to streamline workflows, automate processes, and support data-driven decision-making • Develop lessons learned and best practices documentation • Collaborate with other Amgen R&D Quality functions • Maintain the Rare Disease SharePoint site and Teams channels

🎯 Requirements

• Master’s degree OR Bachelor’s degree and 2 years of scientific or healthcare related experience OR Associate’s degree and 6 years of scientific or healthcare related experience OR High school diploma / GED and 8 years of scientific or healthcare related experience • Understanding of Clinical R&D activities and Global Regulations • Experience working within GCP Quality Compliance preferred • Knowledge and application of international requirements of Good Clinical Practice (GCP)(required) or Good Pharmacovigilance Practice (GPV) and/or Good Laboratory Practice (GLP) • Knowledge of R&D processes and operations • Knowledge of the Regulatory Submission and Inspection Management procedures • Ability to work under pressure and maintain flexibility • Attention to detail • Knowledge of ICH E6R3 as well as 21 CFR 11, SO, 54, 56, 58, 312, and 812 • Proficiency in Microsoft Office • Professional, proactive demeanor • Strong interpersonal skills • Excellent written and verbal communication skills • Sponsorship for this role is not guaranteed

🏖️ 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 • Flexible spending accounts • A discretionary annual bonus program • Stock-based long-term incentives • Award-winning time-off plans • Flexible work models where possible • Career development opportunities • Work/life balance • Financial plans with opportunities to save towards retirement or other goals