Clinical Quality Assurance Manager

This is a fully remote position, open to applicants in United States.

📋 Description

• Manage, implement, and enhance GCP quality systems that support global clinical operations and decentralized clinical trials.

• Deliver quality leadership and strategic guidance to operational teams and departments.

• Oversee daily activities of the Clinical Quality team, which includes workload planning, performance management, coaching, training, and professional growth.

• Supervise QMS records, covering deviations, non-conformances, complaints, protocol deviations, CAPAs, change controls, risk assessments, and quality events.

• Evaluate and authorize investigations while monitoring the effectiveness of CAPAs.

• Analyze inspection trends, quality metrics, KPIs, and emerging compliance risks.

• Provide quality oversight for nursing services, home healthcare, investigational product handling, source documentation, and patient-facing clinical procedures.

• Lead quality oversight for new services, vendors, systems, operational modifications, computerized system validation, equipment qualification, and process validation.

• Review clinical trial documentation, including protocols, ICFs, eCRFs, Pharmacy Manuals, Monitoring Plans, and essential documents.

• Assist with vendor qualification and oversight, audits, requalification, Quality Technical Agreements, and monitoring vendor performance.

• Lead Sponsor audits, regulatory inspections, licensing authority inspections, and client qualification audits.

• Promote continuous improvement, updates to QMS, quality governance, risk-based decision-making, stakeholder collaboration, patient safety, and operational excellence.

⛳️ Requirements

• Bachelor’s Degree or higher, preferably in pharmaceutical, life sciences, or engineering fields.

• 5–7 years of experience in a Clinical Quality-related role.

• At least 2–3 years of experience in people leadership or supervisory roles preferred.

• Background in a CRO, pharmaceutical, biotechnology, healthcare, or other regulated clinical environments.

• Proven experience supporting global clinical trials and decentralized clinical trial initiatives.

• Experience in leading Sponsor audits, regulatory inspections, internal audits, and/or supplier audits.

• Hands-on experience in leading quality investigations, CAPAs, root cause analyses, and quality risk assessments.

• Familiarity with eQMS, eTMF, Microsoft Office, and quality management software applications.

• In-depth knowledge of ICH E6(R3), FDA, EU CTR, MHRA, GCP, GDPR where applicable, and other global regulatory requirements.

• Strong understanding of risk-based quality management, computerized system validation, validation lifecycle principles, and GDP/clinical trial supply logistics where applicable.

• Capability to manage multiple quality activities in a fast-paced global environment.

• Excellent organization, project management, attention to detail, communication, analytical, stakeholder management, and influencing skills.

• Ability to collaborate effectively with Sponsors, auditors, inspectors, vendors, senior leadership, and cross-functional teams.

• Resume must be submitted in English.

• Candidates must reside in a U.S. state where the company is authorized to hire; residents of California, Colorado, New York, Washington, New Jersey, Massachusetts, Illinois, Hawaii, and the District of Columbia are not eligible for this role.

🏝️ Benefits

• Medical, dental, and vision insurance.

• FSA, HSA options.

• Voluntary Critical Illness, Hospital Indemnity, and Accident Insurance.

• Group short-term and long-term disability insurance.

• Group Life Insurance.

• 401K safe harbor plan with company matching.

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

• Paid maternity and paternity leave.

• Wellness, growth, and development initiatives.

• Team-building events.

• An inclusive and supportive work environment.