Senior Manager, Quality Compliance – Rare Disease

🔥 1 minute ago

🇺🇸 United States – Remote

💵 $132k - $178.6k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

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Amgen

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1980

🧬 Biotechnology

💊 Pharmaceuticals

🔬 Science

💰 $28.5G Post-IPO Debt on 2022-12

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.

📋 Description

• Serve as a GCP Subject Matter Expert, providing independent and objective quality advice in support of clinical trial activities and in line with current best practice • Provide quality oversight for Amgen programs for all stages of products in clinical development • Plan, conduct and report out on risk-based GCP audits (investigator site audits, affiliate audits, service provider audits, and study level audits) or support outsourced audits • Manage/support regulatory inspections and provide guidance and feedback on responses to health authorities, including root cause and CAPA plans • Provide quality oversight for the Risk Assessment Categorization Tool (RACT) for each trial to ensure the proper identification, prioritization, and mitigation of risks to critical data and processes and patient safety, welfare, and rights • Support monthly meetings with clinical program level leaders to review quality and compliance related risks, including but not limited to: on-going quality issues/deviations, quality trends, program filing timelines, potential inspections, and risks related to other programs • Support response generation for audit findings and self-reported deviations • Support the establishment of regional expertise to ensure quality and compliance with local regulations • Conduct new vendor qualifications/evaluations in a risk-based manner • Prepare, analyze, and Identify data quality indicators/trends, identify areas of weakness/gaps, recommend and implement corrective actions and communicate quality metrics and other significant quality information on periodic basis to key stakeholders • Support TA-specific oversight of key technologies, including technologies for endpoint data collection and measurement (e.g., biomarker usage and imaging methods) • Support the development of TA-specific Quality Assurance plans that are risk based and efficient. This includes protocol specific audit plans, and the execution of audits using various methods (e.g., remote, or on-site) • Support Clinical Trial Teams for all quality management activities, including management of quality events (e.g., Deviations/CAPAs, Serious Breaches/Privacy Issues, Inspection Readiness activities, and Inspection Management) • Actively seek and implement innovative and proactive quality oversight methodologies (e.g., risk-based, data analytics that may leverage AI and Natural Language Processing, or other statistically based methods) • Review clinical trial protocols ensuring simplification, application of lessons learned, and identification of critical data and processes for risk management activities.

🎯 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 Quality, Operations, and/or Regulatory Compliance experience within the Pharma/Biotech sector OR Bachelor’s degree and 6 years of Quality, Operations, and/or Regulatory Compliance experience within the Pharma/Biotech sector OR Associate’s degree and 10 years of Quality, Operations, and/or Regulatory Compliance experience within the Pharma/Biotech sector OR High school diploma / GED and 12 years of Quality, Operations, and/or Regulatory Compliance experience within the Pharma/Biotech sector • Bachelor of Science degree in appropriate discipline (Preferred Qualifications) • Advanced degree (e.g., Master’s degree or PhD) (Preferred Qualifications) • Quality Assurance Qualification/Certification (Preferred Qualifications) • Minimum of 7 years in biopharmaceutical industry experience in Quality Management, Quality Assurance, or other relevant areas of the pharmaceutical/biotech industry where risk-based quality and quality by design are a core responsibility (Preferred Qualifications) • Minimum of 5 years’ experience as an auditor, preferably in Good Clinical Practice (GCP), Good Laboratory Practice (GLP) and/or Good Pharmacovigilance Practice (GPvP) (Preferred Qualifications) • Experience supporting regulatory authority inspections of clinical research, and/or pharmacovigilance activities (Preferred Qualifications) • Leadership or mentoring experience (Preferred Qualifications) • Oversight and implementation of Quality Management Systems and experience managing quality in electronic QMS such as Veeva or Trackwise (Preferred Qualifications) • Excellent verbal and written communication skills, including strong business writing abilities and active listening (Preferred Qualifications) • Strong analytical, critical-thinking, and decision-making abilities (Preferred Qualifications).

🏖️ 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.