Senior Manager, Quality Compliance – Rare Disease

This is a fully remote position, open to applicants in United States.

📋 Description

• Act as a GCP Subject Matter Expert, offering independent and objective quality guidance to support clinical trial activities in accordance with current best practices.

• Ensure quality oversight for Amgen programs throughout all phases of product clinical development.

• Plan, execute, and report on risk-based GCP audits (including investigator site audits, affiliate audits, service provider audits, and study-level audits) or assist with outsourced audits.

• Manage and support regulatory inspections while providing insights and feedback on responses to health authorities, including root cause analysis and CAPA plans.

• Offer quality oversight for the Risk Assessment Categorization Tool (RACT) for each trial to guarantee the accurate identification, prioritization, and mitigation of risks related to critical data, processes, and patient safety, welfare, and rights.

• Facilitate monthly meetings with clinical program leaders to discuss quality and compliance risks, which may include ongoing quality issues/deviations, quality trends, program filing timelines, potential inspections, and risks associated with other programs.

• Assist in generating responses for audit findings and self-reported deviations.

• Aid in establishing regional expertise to ensure compliance with local regulations and quality standards.

• Conduct vendor qualifications and evaluations using a risk-based approach.

• Prepare, analyze, and identify data quality indicators and trends, pinpointing weaknesses or gaps, recommending and implementing corrective actions, and periodically communicating quality metrics and significant quality information to key stakeholders.

• Provide TA-specific oversight for key technologies, including those for endpoint data collection and measurement (e.g., biomarker usage and imaging techniques).

• Contribute to the development of TA-specific Quality Assurance plans that are efficient and risk-based, including protocol-specific audit plans and executing audits through various methods (e.g., remote or on-site).

• Support Clinical Trial Teams in managing all quality management activities, including handling quality events (e.g., Deviations/CAPAs, Serious Breaches/Privacy Issues, Inspection Readiness activities, and Inspection Management).

• Proactively seek and implement innovative quality oversight methodologies (e.g., risk-based approaches, data analytics leveraging AI and Natural Language Processing, or other statistically based methods).

• Review clinical trial protocols to ensure simplification, incorporate lessons learned, and identify critical data and processes for risk management efforts.

⛳️ Requirements

• Doctorate degree with 2 years of experience in Quality, Operations, and/or Regulatory Compliance within the Pharma/Biotech sector OR Master’s degree with 4 years of relevant experience OR Bachelor’s degree with 6 years of relevant experience OR Associate’s degree with 10 years of relevant experience OR High school diploma / GED with 12 years of relevant experience.

• Bachelor of Science degree in a relevant discipline (Preferred Qualifications).

• Advanced degree (e.g., Master’s or PhD) (Preferred Qualifications).

• Quality Assurance Qualification/Certification (Preferred Qualifications).

• At least 7 years of experience in the biopharmaceutical industry in Quality Management, Quality Assurance, or other areas where risk-based quality and quality by design are primary responsibilities (Preferred Qualifications).

• Minimum of 5 years of auditing experience, preferably in Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and/or Good Pharmacovigilance Practice (GPvP) (Preferred Qualifications).

• Experience in supporting regulatory authority inspections of clinical research or pharmacovigilance activities (Preferred Qualifications).

• Leadership or mentoring experience (Preferred Qualifications).

• Experience in overseeing and implementing Quality Management Systems, including managing quality in electronic QMS such as Veeva or Trackwise (Preferred Qualifications).

• Strong verbal and written communication skills, including excellent business writing abilities and active listening (Preferred Qualifications).

• Robust analytical, critical-thinking, and decision-making skills (Preferred Qualifications).

🏝️ Benefits

• A comprehensive employee benefits package, which includes 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 feasible.