Senior Clinical Quality Assurance Associate

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior Clinical Quality Assurance Associate based in the United States.

The Senior Clinical Quality Assurance Associate will play a critical role in maintaining and enhancing quality standards across global clinical operations. This position provides strategic quality oversight for clinical research activities, including decentralized clinical trials and patient-focused healthcare services. You will collaborate with cross-functional teams to ensure compliance with global regulations, sponsor expectations, and established quality systems. The role combines quality expertise, risk management, and continuous improvement to support safe, efficient, and reliable clinical trial delivery. You will contribute to investigations, audits, process improvements, and quality initiatives that directly impact clinical research outcomes. This is an opportunity to join a mission-driven environment focused on innovation, collaboration, and improving access to healthcare solutions.

Accountabilities:: The Senior Clinical Quality Assurance Associate is responsible for overseeing GCP quality systems, supporting global clinical operations, and ensuring consistent compliance across clinical activities. This role acts as a quality partner to operational teams while driving continuous improvement and risk-based quality management practices.

Serve as a subject matter expert for GCP quality systems across global clinical operations.

Provide QA oversight and guidance to Clinical Operations, Nursing, Project Management, Medical Affairs, Pharmacovigilance, Regulatory Affairs, and other operational teams.

Lead investigations into non-conformances, complaints, protocol deviations, quality events, and compliance concerns.

Manage CAPA activities from root cause investigation through implementation, effectiveness checks, and final closure.

Conduct quality risk assessments for new services, processes, vendors, systems, and operational changes.

Review clinical and GCP documentation, including protocols, informed consent forms, eCRFs, monitoring plans, pharmacy documentation, and essential trial records.

Support decentralized clinical trial quality activities involving nursing services, home healthcare, source documentation, and clinical trial supply processes.

Maintain and improve QMS documentation, including deviations, CAPAs, change controls, SOPs, templates, forms, and quality guidance materials.

Support vendor qualification activities, audits, requalification processes, quality agreements, and vendor performance monitoring.

Assist with sponsor audits, regulatory inspections, and internal audits by coordinating readiness activities, documentation reviews, responses, and corrective actions.

Analyze quality metrics and trends to identify improvement opportunities, escalate risks, and promote a strong culture of compliance.

Support validation and qualification activities while contributing to cross-functional quality projects and mentoring team members.

Requirements:

The ideal candidate will have experience in clinical quality assurance within a regulated healthcare, pharmaceutical, biotechnology, or CRO environment, with strong knowledge of GCP requirements and quality management principles.

Bachelor’s degree or higher, preferably in pharmaceutical sciences, life sciences, engineering, or a related discipline.

3+ years of experience in a quality-focused role within clinical research, healthcare, biotechnology, pharmaceutical, or CRO organizations.

Experience supporting global clinical trials and decentralized clinical trial activities.

Experience participating in sponsor audits, regulatory inspections, internal audits, and supplier/vendor audits.

Hands-on experience with quality investigations, CAPA management, root cause analysis, risk assessments, and continuous improvement initiatives.

Strong understanding of Quality Management Systems, risk-based quality management principles, and validation lifecycle concepts.

Working knowledge of GCP regulations and global regulatory expectations, including ICH E6(R3), FDA requirements, EU Clinical Trial Regulation, MHRA, GDPR, and related standards.

Experience using eQMS, eTMF platforms, Microsoft Office tools, and quality management software applications.

Knowledge of GDP, clinical trial supply processes, warehousing, and logistics is considered an advantage.

Strong analytical, organizational, communication, and stakeholder management skills.

Ability to manage multiple priorities, handle confidential information professionally, and work independently in a remote environment.

Detail-oriented, process-driven, accountable, and collaborative approach with strong problem-solving skills.

Benefits:

Medical, dental, and vision insurance coverage.

Flexible Spending Account (FSA) and Health Savings Account (HSA) options.

Voluntary critical illness, hospital indemnity, and accident insurance plans.

Short-term and long-term disability coverage.

Company-provided life insurance.

401(k) safe harbor plan with company match.

Paid vacation, holidays, sick leave, and volunteer time.

Paid maternity and paternity leave.

Opportunities for professional growth, wellness initiatives, and employee development.

Supportive, inclusive, and collaborative work environment focused on team success.

Remote work flexibility for eligible U.S.-based employees.

How Jobgether works: We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team. We appreciate your interest and wish you the best!  Why Apply Through Jobgether?    Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.     #LI-CL1