Senior Manager, Quality Compliance – Rare Disease

🕒 June 25

🇺🇸 United States – Remote

💵 $132k - $178.6k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 42%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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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

• Serve as a GCP Subject Matter Expert, providing independent and objective quality advice supporting clinical trial activities • Provide quality oversight for Amgen programs across all stages of products in clinical development • Plan, conduct, and report on risk-based GCP audits, or support outsourced audits • Manage and support regulatory inspections and provide guidance on health-authority responses, including root cause and CAPA plans • Provide quality oversight for the Risk Assessment Categorization Tool for each trial • Support monthly meetings with clinical program leaders to review quality and compliance risks • Support response generation for audit findings and self-reported deviations • Support regional expertise for quality and compliance with local regulations • Conduct risk-based new vendor qualifications and evaluations • Prepare and analyze data quality indicators and trends; identify gaps and implement corrective actions • Communicate quality metrics and significant quality information to stakeholders • Support oversight of technologies for endpoint data collection and measurement • Support development of risk-based, efficient therapeutic-area Quality Assurance plans and protocol-specific audit plans • Support Clinical Trial Teams with quality management activities, including deviations/CAPAs, serious breaches/privacy issues, inspection readiness, and inspection management • Implement innovative quality oversight methodologies, including risk-based analytics, AI, and Natural Language Processing • Review clinical trial protocols for simplification, lessons learned, and identification of critical data and processes • Maintain current regulatory and quality knowledge and provide training and education • Coach and mentor staff and provide cross-training • Manage multiple assignments and meet audit reporting timelines • Support departmental goals

🎯 Requirements

• Doctorate degree and 2 years of Quality, Operations, and/or Regulatory Compliance experience within the Pharma/Biotech sector OR Master’s degree and 4 years of relevant experience OR Bachelor’s degree and 6 years of relevant experience OR Associate’s degree and 10 years of relevant experience OR High school diploma/GED and 12 years of relevant experience • Minimum of 7 years in biopharmaceutical industry experience in Quality Management, Quality Assurance, or other relevant areas • Minimum of 5 years’ experience as an auditor, preferably in GCP, GLP and/or GPvP • Experience supporting regulatory authority inspections of clinical research and/or pharmacovigilance activities • Leadership or mentoring experience • Oversight and implementation of Quality Management Systems • Experience managing quality in electronic QMS such as Veeva or Trackwise • Thorough knowledge and application of international GCP and/or GPV requirements • Knowledge of R&D processes and operations • Knowledge of Regulatory Submission and Inspection Management procedures • Quality oversight of clinical trials, including protocol development, execution, and submissions • Technical knowledge of at least one R&D audit specialty area • Excellent verbal and written communication skills, including strong business writing abilities and active listening • Strong analytical, critical-thinking, and decision-making abilities • Ability to communicate effectively locally, regionally, and globally

🏖️ 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