Senior Manager, Clinical Quality Assurance (Remote)

Elevar Therapeutics; United States; Remote; USD 140,000 - 180,000; Full time

Benefits offered by this job

Medical

Dental

Vision

Retirement plan

Time off

Voluntary benefits

Job summary

Elevar Therapeutics seeks a Senior Manager, Clinical Quality Assurance to lead quality oversight of clinical activities and ensure trials meet GCP and company SOP standards. This remote-based role is located in the United States, interfacing with Drug Development and corporate QA to audit vendors, sites, and internal processes.

The role requires extensive CQA experience, strong knowledge of GCP, ICH guidelines, and regulatory inspections, plus the ability to work cross-functionally and drive

Qualifications

• Bachelor’s degree with [12] years of experience or Master’s with 5+ years, plus cross‑functional leadership.
• Extensive Clinical Quality experience in biotech/pharma and remote teamwork.
• Deep knowledge of GCP, ICH guidelines, FDA CFR and regulatory frameworks.

Responsibilities

• Oversee clinical quality assurance activities to ensure GCP compliance.
• Interface with Drug Development and QA to audit vendors, sites and trials.
• Draft and manage quality plans, risk management, and inspection readiness.
• Prepare materials for regulatory submissions and support audit findings.
• Provide cross‑functional clinical operations input and drive corrective actions.

Skills

GCP Knowledge

ICH Guidelines

FDA CFR knowledge

Regulatory inspections

QA Applications/Databases

Problem Solving

Education

Bachelor’s degree

Master’s degree (preferred)

Tools

QA Software

Job description

Description

The Senior Manager, Clinical Quality Assurance is responsible for supporting Quality oversight of clinical activities. The Senior Manager, Clinical Quality Assurance performs and manages clinical quality assurance activities and is responsible for ensuring that clinical trials are conducted to the highest GCP and quality standards and clinical processes within the Clinical Group are conducted in accordance with corporate SOPs, guidelines, and regulations.

This is a remote-based position located in the United States.

• Ensure that all processes contributing to the performance of a clinical trial are conducted properly
• Prepare and manage the Drug Development Quality Management Plan including risk management, SOPs, training, regulatory compliance, and audit readiness
• Evaluate adequacy of quality assurance standards for the Drug Development Group
• Directly interface with Drug Development departments and corporate QA to provide for vendor, site, and internal GCP audits
• Evaluate audit findings and review/approve corrective actions
• Support compilation and preparation of materials for submission to regulatory agencies
• Evaluate quality events, incidents, and queries
• Provide clinical operations expertise in cross-functional meetings and will directly work or manage teams that work closely with overall compliance and quality in accordance with Elevar SOPs, ICH guidelines, and GCP best practices
• Draft clinical quality assurance policies and procedures in accordance with corporate QA policies and standards
• Ensure inspection readiness of all regulated activities

Responsibilities

• Ensure that all processes contributing to the performance of a clinical trial are conducted properly
• Prepare and manage the Drug Development Quality Management Plan including risk management, SOPs, training, regulatory compliance, and audit readinessEvaluate adequacy of quality assurance standards for the Drug Development Group
• Directly interface with Drug Development departments and corporate QA to provide for vendor, site, and internal GCP audits
• Evaluate audit findings and review/approve corrective actions
• Support compilation and preparation of materials for submission to regulatory agencies
• Evaluate quality events, incidents, and queries
• Provide clinical operations expertise in cross-functional meetings and will directly work or manage teams that work closely with overall compliance and quality in accordance with Elevar SOPs, ICH guidelines, and GCP best practices
• Draft clinical quality assurance policies and procedures in accordance with corporate QA policies and standards
• Ensure inspection readiness of all regulated activities

Requirements

• Bachelor’s degree with 12 years' experience; Master’s degree with 5 years' experience; proven management experience demonstrating business acumen, developing and delivering functional/department goals, delivering results, championing innovation, including remote and cross-functional teams
• More than 5 years of Clinical Quality-related experience in the biotech/pharmaceutical industry
• Experience with Clinical Quality requirements in Europe
• Experience in oncology therapeutic area
• Expert knowledge of Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines FDA CFR, PhRMA code, clinical research ethics, HIPAA and patient privacy laws, EU Directive, and other applicable international regulations
• Thorough working knowledge on compliance and inspection readiness
• Strong computer skills including Microsoft Office, QA applications and databases
• Knowledge of tools, concepts, and methodologies of QA
• Record of successfully completed FDA and regulatory authority inspections
• Data collection, management, and analysis
• Problem analysis and problem-solving
• Ability to demonstrate Elevar’s core values by holding ourselves and each other accountable for the work we do, taking time to collaborate effectively while working remotely, making space for ingenuity in work and thought, and staying grounded in compassion

The anticipated annual base salary range for this role is $140,000 to $180,000. Final compensation depends on multiple factors including but not limited to, relevant experience, skillset, depth and breadth of knowledge, internal equity, and external market factors. Elevar Therapeutics is a rapidly growing biotech company that offers competitive wages and benefits package including medical, dental, vision, time off, a retirement plan, and other voluntary benefits for employees.