Role Objectives:The
Senior Clinical Quality Assurance Associate is responsible for the oversight, implementation, and continuous improvement of GCP quality systems supporting global clinical operations across all clinical activities, including decentralised clinical trials (DCTs) that involve nursing services and in-home patient care. This role provides quality leadership to operational teams by ensuring compliance with ICH GCP, applicable global regulatory requirements, Sponsor expectations, and internal Quality Management System (QMS) processes.
The Ideal Candidate:- Attention to detail
- Process-driven
- Accountable
- Collaborative
What You'll Do:- Serve as GCP quality systems SME across global clinical operations.
- Provide QA oversight to Clinical Operations, Nursing, Project Management, Medical Affairs, Pharmacovigilance, Regulatory Affairs, and other operational teams.
- Lead investigations for non-conformances, complaints, protocol deviations, quality events, and compliance issues.
- Independently manage complex CAPAs from investigation through effectiveness checks and closure.
- Lead risk assessments for new services, processes, vendors, systems, and operational changes.
- Review clinical and GCP documentation, including protocols, ICFs, eCRFs, Pharmacy Manuals, Monitoring Plans, and essential documents.
- Oversee decentralized clinical trial activities, including nursing, home healthcare, source documentation, IP handling, and related processes.
- Support QMS records and documentation, including deviations, CAPAs, complaints, change controls, risk assessments, SOPs, forms, templates, and guidance documents.
- Review change controls, support approvals, and lead post-implementation effectiveness reviews.
- Support vendor qualification, audits, requalification, Quality Technical Agreements, and ongoing vendor performance monitoring.
- Support audits and inspections by managing readiness, documentation, responses, corrective action plans, evidence, and commitment tracking.
- Review quality metrics, identify trends and risks, drive improvements, support validation/qualification activities, mentor QA staff, represent Quality on cross-functional projects, escalate significant risks, and promote a culture of quality and compliance.
What You'll Need:- Bachelor's Degree or higher (preference for pharmaceutical, life sciences, or engineering concentration)
- 3 to 5 years of experience in a quality-related role within a CRO, pharmaceutical, biotechnology, or healthcare organization
- Experience supporting global clinical trials and decentralized clinical trial activities
- Experience supporting Sponsor audits, regulatory inspections, internal audits, and/or supplier audits
- Practical experience with quality investigations, CAPAs, root cause analysis, quality risk assessments, and continuous improvement
- Experience with eQMS, eTMF, Microsoft Office, and quality management software applications
- Working knowledge of GCP regulations and global regulatory expectations, including ICH E6(R3), FDA, EU Clinical Trial Regulation, MHRA, GDPR where applicable, and related requirements
- Strong understanding of Quality Management Systems, risk-based quality management principles, and computerized system validation or validation lifecycle principles
- Practical understanding of GDP, warehousing, logistics, and clinical trial supply processes is advantageous
- Strong analytical, organizational, communication, stakeholder management, mentoring, and influencing skills, with the ability to manage multiple priorities, handle confidential information professionally, and apply a proactive, solutions-focused mindset
Location eligibility applies. Candidates must reside in a U.S. state where the company is authorized to hire. This role is not eligible for residents of: California, Colorado, New York, Washington, New Jersey, Massachusetts, Illinois, Hawaii, and District of Columbia. What We Offer:Medical, dental, and vision insurance
FSA, HSA
Voluntary Critical Illness, Hospital Indemnity, and Accident Insurance
Group short-term and long-term disability insurance
Group Life Insurance
401K safe harbor plan and company match
Paid vacation, holiday, sick and volunteer time
Paid maternity & paternity leave
#LI-Fulltime #LI-remote
We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
