Manager, Research Quality

Astera Cancer Care; Northern (KY); Hybrid; USD 90,000 - 130,000; Full time

Job summary

OneOncology seeks a senior quality assurance professional to advance the network's quality management system and drive regulatory compliance across sites. You will lead CAPA, monitor KPIs, oversee vendor qualification, and prep sites for sponsor/CRO audits and inspections.

Collaboration with directors and cross-functional teams will be essential to achieve continuous improvement in clinical research quality.

Qualifications

• Bachelor's degree required; advanced degree preferred.
• Experience supporting FDA inspections highly preferred.
• Professional certification in clinical research and/or quality assurance highly preferred.

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 documentation, investigations, resolution and effectiveness evaluation of quality issues and audit findings.
• Oversee vendor qualification by coordinating assessments, maintaining docs, evaluating risks, ensuring regulatory and quality expectations.
• Prepare sites for sponsor/CRO audits and regulatory inspections; review documentation and resolve gaps.
• Serve as a resource for quality teammates including auditors and QC specialists.
• Support KPIs to assess effectiveness of quality management systems and drive continuous improvement.
• Promote programs for quality control, audits, inspections, and assessments across sites.
• Provide strategic guidance on SOPs and procedural documents to ensure regulatory alignment.
• Act as SME on regulatory requirements and advise stakeholders on compliance implications.
• Contribute to training programs on QA, regulatory compliance and clinical research best practices.
• Other duties as assigned to improve lives of people with cancer.

Skills

GCP knowledge

FDA regulations

ICH guidelines

Quality assurance

Regulatory compliance

Audits

Training delivery

Cross-functional collaboration

MS Office

Education

Bachelor's degree in a relevant field

Advanced degree preferred

Tools

CTMS

EDC systems

Electronic regulatory binders

MS Office software

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.

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.

#LI-REMOTE OneOncology was founded by community physicians, for community physicians, with the mission of improving the lives of everyone living with cancer and other diseases. Our goal is to enable community medical practices to remain independent and to improve patient access to care in their communities, all at a lower cost than in the hospital setting. OneOncology supports our platform of community medical practices through group purchasing, operational optimization, practice growth, and clinical innovation. Our partner practices comprise approximately 2,300+ providers who care for approximately 1.5 million patients across 20 states.