Senior Associate – Clinical Quality
Location: Des Plaines, Illinois, United States | Category: Medical & Clinical Affairs | Employment Type: Full-Time
Company Overview:
Abbott is a global healthcare leader dedicated to improving lives at every stage through innovative diagnostics, medical devices, nutritionals, and branded generic medicines. With over 114,000 colleagues in 160+ countries, Abbott delivers life-changing technologies that empower patients and healthcare professionals worldwide.
Role Overview:
Abbott Molecular Diagnostics is seeking a Senior Associate – Clinical Quality to support Clinical Development (CD) teams in ensuring compliance with GCP regulations, ISO standards, and internal policies. This role will provide quality oversight of clinical studies, help mitigate compliance risks, and promote continuous improvement initiatives.
Key Responsibilities:
Clinical Study Support:
Review protocols, informed consent forms (ICFs), case report forms (CRFs), and essential study documentation for product and process changes.
Provide guidance to project teams to mitigate compliance risks and ensure adherence to company standards.
Represent Clinical Quality in project meetings and protocol deviation discussions to promote quality and regulatory compliance.
Compliance & Training:
Advise Clinical Development staff on GCP regulations, ISO standards, and departmental procedures.
Facilitate training sessions for clinical staff to ensure quality compliance and adherence to best practices.
Coordinate Continuous Improvement Detection (CID) and CAPA processes, including follow-up and closure of corrective actions.
Audit & Inspection Support:
Assist project teams and investigational sites in preparation for internal audits (AQR) and regulatory authority inspections.
Support quality-related documentation and evidence for audits and regulatory submissions.
Required Qualifications:
Bachelor’s degree in Life Sciences or related field.
Minimum of 5 years of experience in clinical research, medical devices, or a related industry.
Preferred Qualifications:
At least 3 years in a clinical quality role within medical devices or clinical trial environments.
GCP audit experience is highly desirable.
Compensation & Benefits:
Base pay: $78,000 – $156,000 (location-dependent).
Access to comprehensive health coverage, retirement plans, tuition reimbursement, and professional development opportunities.
Why Abbott:
Join Abbott as a Senior Associate – Clinical Quality and contribute to ensuring the integrity, compliance, and quality of clinical studies for innovative molecular diagnostics. Play a vital role in helping patients worldwide access life-changing healthcare solutions.
Apply Now:
Take the next step in your clinical quality career with Abbott and be part of a global team delivering excellence in healthcare innovation.
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