Manager, Research Quality

OneOncology; United States; On-site; USD 110,000 - 160,000; Full time

Job summary

OneOncology is seeking a Manager, Research Quality to lead quality programs across the OneR network, ensuring regulatory compliance and governance of CAPA, audits, and vendor qualification to uphold top-tier clinical research standards.

The role partners with cross-functional teams to drive continuous improvement and supports sponsor/CRO inspections. Travel ~25% is required for site visits and audits.

Qualifications

• Experience in clinical research quality assurance and regulatory compliance.
• Experience supporting FDA inspections.
• Professional certification in clinical research or quality assurance preferred.

Responsibilities

• Advance the quality management system for the network.
• Monitor KPI health of quality operations.
• Lead CAPA program including investigations and effectiveness.
• Oversee vendor qualification and regulatory risk assessments.
• Prepare sites for sponsor/CRO audits and regulatory inspections.

Skills

GCP knowledge

FDA regulations

ICH guidelines

Quality management

Audits & inspections

Regulatory compliance

Cross-functional collaboration

Analytical thinking

Education

Bachelor's degree

Advanced degree in a relevant scientific discipline

Tools

Microsoft Office

EDC systems

Electronic regulatory binders

CTMS

Job description

OneOncology is positioning community oncologists to drive the future of medical care through a patient-centric, physician-driven, and technology-powered model to help improve the lives of everyone living with cancer and other diseases. Our team is bringing together leaders to the market place to help drive OneOncology’s mission and vision.

Why join us? This is an exciting time to join OneOncology. Our values-driven culture reflects our startup enthusiasm supported by industry leaders in oncology, urology, technology, and finance. We are looking for talented and highly-motivated individuals who demonstrate a natural desire to improve and build new processes that support the meaningful work of independent physicians and the patients they serve.

Job Description

The Manager, Research Quality will report to the Director, Research Quality. As a key member of the OneOncology Research Network (OneR) Quality team, this individual will partner with OneR departments and OneOncology practices to support the development of a quality function that advances clinical research across the network and at the practice level.

The Manager, Research Quality is a key role in the advancement of the highest standards of quality and compliance within clinical research operations. This position requires a comprehensive understanding of regulatory requirements, industry standards, and best practices related to clinical research. This position plays a pivotal role in safeguarding the integrity, safety, and ethical conduct of clinical trials.

Responsibilities

• Support the Director, Research Quality, in advancing the quality management system for the network
• Monitor and report on network’s KPIs that measure the health of the quality operations
• Lead the CAPA program by overseeing the identification, documentation, investigation, resolution, and effectiveness evaluation of quality issues, audit findings, and process deviations to promote sustainable corrective and preventive actions within OneR and across network sites
• Oversee the vendor qualification program by coordinating vendor assessments, maintaining qualification documentation, evaluating quality and compliance risks, and partnering with stakeholders to ensure vendors meet applicable regulatory, operational, and OneR quality expectations.
• Facilitate audit readiness activities by preparing network sites for sponsor/CRO audits and regulatory inspections while partnering with other quality team members for documentation review, issue escalation, and resolution of identified gaps.
• Serve as a resource for quality department teammates including specialists, auditors, and quality control specialists
• Support the Director, Research Quality and OneR executive leadership in establishing and monitoring key performance indicators (KPIs) to assess the effectiveness of quality management systems, inform decision-making, and drive continuous improvement initiatives across the research network
• Promote the implementation of programs for quality control, audits, inspections, and assessments to evaluate compliance with protocols, regulations, and standard operating procedures (SOPs) both internally and across network sites.
• Partner with the Director, Research Quality to provide strategic guidance to OneR and partner practices in the development, implementation, and optimization of SOPs and procedural documents to support compliant conduct and ensure alignment with regulatory expectations and operational best practices.
• Ability to serve as a subject matter expert on regulatory requirements, interpreting evolving regulations and advising stakeholders on compliance implications.
• Contribute to network-wide training programs on quality assurance, regulatory compliance, and best practices in clinical research; deliver training.
• Other duties as assigned to help drive our mission of improving the lives of everyone living with cancer.

Required or Preferred Qualifications

• 4-8+ years of experience clinical research quality assurance, regulatory compliance, training and education.
• Bachelor’s degree required, advanced degree in a relevant scientific discipline preferred.
• Experience supporting FDA inspections highly preferred.
• Professional certification in clinical research and/or quality assurance highly preferred.
• Proficiency in Microsoft Office applications, electronic data capture (EDC) systems, electronic regulatory binders, and clinical trial management systems (CTMS)
• Ability to travel ~25%

Essential Competencies

• Demonstrated problem-solving and analytical capabilities.
• In-depth knowledge of GCP, FDA regulations, ICH guidelines, and industry best practices as it relates to clinical trial quality assurance and the ability to interpret and operationalize regulatory requirements into scalable quality initiatives.
• Proven track record of developing and leading organizational quality programs and quality management initiatives, conducting audits and inspections, and driving process improvements.
• Excellent written and verbal communication skills with the ability to distill complex compliance issues for executive leadership and cross-functional teams.
• Proven ability to think critically and balance strategic oversight with tactical execution by managing competing priorities, deadlines, and deliverables both independently and as part of a team.
• Excellent interpersonal skills, ability to build trust, and high emotional intelligence in partnering with research staff and other subject matter experts to maintain effective working relationships within OneR and with practice partners.
• Demonstrated success in building and leading a team.
• Ability to work cross-functionally to deliver on key initiatives.
• Attendance is an essential job function.