Role Objectives:

The Clinical Quality Assurance Manager is responsible for the strategic leadership, oversight, and continuous improvement of the Good Clinical Practice (GCP) Quality Management System (QMS) supporting global clinical operations, including decentralised clinical trials (DCTs) involving nursing services and in-home patient care. This role is accountable for ensuring quality systems remain compliant with ICH GCP, applicable global regulatory requirements, Sponsor expectations, and internal quality standards while fostering a culture of quality, risk management, operational excellence, and continuous improvement.

The Clinical Quality Assurance Manager provides leadership to the Clinical QA team, partners with operational leadership across the organization, and serves as the primary quality advisor for clinical operations, regulatory inspections, Sponsor audits, and strategic business initiatives.

The Ideal Candidate:

• Proactive and self-motivated
• Calm and logical under pressure
• Confident communicator
• Strong leadership mindset

What You'll Do:

• Manage day-to-day Clinical Quality team activities, including workload planning, prioritization, performance management, coaching, training, and professional development.
• Provide cross-functional oversight of the GCP Quality Management System to ensure compliance with applicable regulations, Sponsor requirements, and company procedures.
• Serve as the functional leader and strategic quality advisor for GCP quality activities across global clinical operations and operational departments.
• Oversee QMS records, including deviations, non-conformances, complaints, protocol deviations, CAPAs, change controls, risk assessments, and quality events.
• Review and approve investigations, ensuring they are robust, risk assessed, completed within timelines, and supported by appropriate corrective and preventive actions.
• Monitor CAPA effectiveness, inspection trends, quality metrics, KPIs, and emerging compliance risks to identify systemic improvement opportunities and mitigation strategies.
• Provide quality oversight for decentralized clinical trial activities, including nursing services, home healthcare, investigational product handling, source documentation, and patient-facing clinical processes.
• Lead quality oversight for new services, processes, vendors, systems, operational changes, computerized system validation, equipment qualification, and process validation activities impacting GCP operations.
• Oversee quality reviews of clinical trial documentation, including protocols, ICFs, eCRFs, Pharmacy Manuals, Monitoring Plans, essential documents, and other applicable GCP documentation.
• Support vendor qualification and oversight, including quality risk assessments, audits, periodic requalification, Quality Technical Agreements, and ongoing vendor performance monitoring.
• Lead Sponsor audits, regulatory inspections, licensing authority inspections, and client qualification audits, including inspection readiness, documentation review, audit responses, and commitment tracking.
• Drive continuous improvement, QMS documentation updates, quality governance, risk-based decision-making, stakeholder collaboration, and a proactive culture of quality, compliance, patient safety, and operational excellence.

What You'll Need:

• Bachelor's Degree or higher (preference for pharmaceutical, life sciences, or engineering concentration)
• 5-7 years' experience in a Clinical Quality related role
• Minimum 2-3 years of people leadership or supervisory experience preferred.
• Experience within a CRO, pharmaceutical, biotechnology, healthcare, or other regulated clinical environment.
• Demonstrated experience supporting global clinical trials and decentralized clinical trial activities.
• Experience leading Sponsor audits, regulatory inspections, internal audits, and/or supplier audits.
• Practical experience leading quality investigations, CAPAs, root cause analyses, and quality risk assessments.
• Experience with eQMS, eTMF, Microsoft Office, and quality management software applications.
• Strong knowledge of ICH E6(R3), FDA, EU CTR, MHRA, GCP, GDPR where applicable, and other global regulatory expectations.
• Strong understanding of risk-based quality management, computerized system validation, validation lifecycle principles, and GDP/clinical trial supply logistics where applicable.
• Ability to manage multiple quality activities in a fast-paced global environment with strong organization, project management, and attention to detail.
• Strong communication, analytical, stakeholder management, and influencing skills, with the ability to work effectively with Sponsors, auditors, inspectors, vendors, senior leadership, and cross-functional teams.

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.