Quality Compliance Senior Manager

February 3

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Amgen

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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.

Biologics • Human therapeutics • Development of novel products

10,000+ employees

Founded 1980

🧬 Biotechnology

💊 Pharmaceuticals

🔬 Science

💰 Post-IPO Debt on 2022-12

📋 Description

• Join Amgen’s Mission of Serving Patients • Provide proactive end to end quality support for the development and implementation of a risk-based quality assurance strategy • Manage/support regulatory inspections and provide guidance and feedback on responses to health authorities • Serve as a GCP Subject Matter Expert, providing independent and objective quality advice • 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 • Review clinical trial protocols ensuring simplification, application of lessons learned, and identification of critical data and processes

🎯 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 • Minimum of 2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. • 7 years or more experience in Quality Management , Quality Assurance , or other relevant areas of the pharmaceutical/biotech industry • Experience with leading Regulatory Agency inspections including managing pre-inspection requests, storyboarding, Front Room and Back Room management, and responses to inspection findings. • Experience with Inspection planning including timeline management, mock inspections, and interview preparation • Leadership or mentoring experience. • Oversight and implementation of Quality Management Systems and experience managing quality in electronic QMS such as Veeva or Track wise.

🏖️ 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, 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