Senior Clinical Quality Assurance Associate

WEP Clinical

Quality Assurance Manager overseeing clinical quality assurance operations for drug manufacturing and distribution. Leading compliance and operational improvements in clinical trials and related activities.

Posted 7/22/2026full-timeRemote • California, Colorado, District of Columbia, Hawaii, Illinois, Massachusetts, New Jersey, New York, Washington • 🇺🇸 United StatesSeniorWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in Quality Assurance leadership and operational execution within pharmaceutical and clinical trial environments, with a strong focus on compliance with regulatory standards and continuous improvement methodologies.

Highest-signal resume keywords

Quality Management SystemsGood Manufacturing PracticeClinical Trial Supply ManagementRegulatory ComplianceQuality Investigations

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Quality Risk AssessmentRoot Cause AnalysisCAPAEQMSETMFQuality Management SoftwareGCP RegulationsICH E6(R3)FDA RegulationsEU Clinical Trial Regulation

Soft Skills

Analytical SkillsOrganizational SkillsCommunication SkillsStakeholder ManagementMentoring Skills

Tools & Technologies

Microsoft OfficeQuality Management Software Applications

Industry Keywords

PharmaceuticalBiotechnologyHealthcareCRODecentralized Clinical Trials

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Responsible for the leadership and operational execution of the site quality assurance function regarding the distribution and manufacturing (secondary packaging & labelling) activities.
Oversee and drive day-to-day site operations, driving compliance to regulatory Good Manufacturing and Distribution Practice standards and operational improvements.
Act as a primary expert and interface between supply chain and logistics, project management and other departments to drive delivery of client solutions with respects to Post Approval Named Patient/Expanded Access Program and Clinical Trial supply service lines for the site.

Requirements

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

Benefits

Comp & perks

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