GCP Auditor – Global R&D Audit

🔥 1 minute ago

🇺🇸 United States – Remote

💵 $104.7k - $141.7k / year

⏰ Full Time

🟠 Senior

🔴 Lead

🔎 Auditor

🦅 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

• Plan, conduct and report routine and direct GCP compliance audits internationally • Serve as a lead auditor for complex GCP audits • Identify and communicate compliance risks to R&D Quality management • Host and/or play a role in regulatory authority inspections • Contribute to or lead R&D Quality process improvement initiatives • Author and contribute to the development of R&D Quality cross functional controlled documents • Support regulatory inspections of clinical sites and Amgen facilities

🎯 Requirements

• Doctorate degree OR • Master’s degree and 2 years of scientific discipline, medical sciences or pharmacy experience OR • Bachelor’s degree and 4 years of scientific discipline, medical sciences or pharmacy experience OR • Associate’s degree and 8 years of scientific discipline, medical sciences or pharmacy experience OR • High school diploma / GED and 10 years of scientific discipline, medical sciences or pharmacy experience • Postgraduate qualification • Participation in process improvement initiatives • Extensive experience conducting international auditing in GCP or as a regulatory authority inspector • Experience of data mining, manipulation and data analytics would be advantageous • Excellent written and verbal communication skills • Ability to travel internationally, up to 40%

🏖️ 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 • Financial plans with opportunities to save towards retirement or other goals • Work/life balance support