Clinical Quality Assurance Manager

Clinical Quality Assurance Manager

Location:100% RemoteContract Type:Independent Contractor AgreementCompensation:USD $4,000–$6,000 per month (based on experience)

About the Role

We are seeking an experiencedClinical Quality Assurance Managerto lead quality and compliance initiatives across our Clinical Development organization. This role is responsible for building and maintaining robust Clinical Quality Assurance processes while ensuring compliance with GCP, FDA, ICH, and other applicable regulatory standards.

The ideal candidate will have extensive experience supporting clinical trials within pharmaceutical or biotechnology environments, leading inspection readiness activities, managing audits, and implementing risk-based quality systems. This is a highly collaborative role requiring close partnership with Clinical Operations, Regulatory Affairs, and other cross-functional teams to ensure the successful execution of clinical development programs.

Key Responsibilities
* Support the Clinical Development organization in implementing risk-based quality oversight for clinical trials using Quality by Design (QbD) and Quality Risk Management principles.
* Serve as the Clinical Quality Assurance Subject Matter Expert (SME) on cross-functional project teams.
* Proactively identify quality risks, deviations, and compliance issues while driving timely resolution and documentation.
* Lead investigations related to protocol deviations, quality events, root cause analyses, and Corrective and Preventive Actions (CAPAs).
* Create, review, and approve risk assessments and impact assessments associated with study design changes and clinical systems.
* Develop and maintain a risk-based audit program covering internal processes, investigator sites, and external vendors.
* Establish and continuously improve Clinical Quality procedures, tools, and compliance frameworks.
* Collaborate with internal stakeholders to develop and execute GCP audit plans.
* Build and strengthen the Clinical Quality Assurance and Compliance function and supporting infrastructure.
* Develop, implement, and maintain GCP training, compliance programs, and inspection readiness initiatives.
* Lead inspection readiness activities and provide ongoing support to clinical study teams.
* Prepare clinical teams for internal audits and regulatory inspections, including FDA and other global health authorities.
* Partner cross-functionally to ensure continuous compliance and operational excellence throughout the clinical development lifecycle.

Qualifications
* Minimum of5 years of Clinical Quality Assurance experiencewithin a pharmaceutical or biotechnology company.
* Strong experience working within regulatedGCP/ICH environmentsand quality management systems.
* Proven experience leading inspection readiness activities and hostingFDA and/or other regulatory agency inspections.
* Experience managing internal audits, vendor audits, and investigator site audits.
* Strong knowledge ofGood Clinical Practice (GCP),FDA regulations, andICH guidelines, includingICH E6(R2).
* Extensive experience implementing and maintaining risk-based quality management systems.
* Demonstrated ability to manage CAPAs, investigations, quality events, and compliance initiatives.
* Excellent organizational, communication, and cross-functional collaboration skills.
* Ability to work independently in a fully remote environment while supporting teams across multiple functions.