Quality Assurance Manager

Role Overview

• Internal Auditing: independently lead and conduct internal audits and related GxP activities including Investigator site audits, process audits, vendor qualifications, vendor audits, and other specialized audits or quality investigations as defined by leadership.
• External audits: provide quality and compliance support on sponsor audits, client audits, and regulatory inspections.
• Quality Issue/CAPA management: support RCA/CAPA development, tracking, and completion. Works with department to implement and verify CAPAs. Evaluate audit findings, review Quality Issue classification, and review documentation related to QI management. Perform effectiveness checks.
• Documentation and reporting: Produce clear and evidence-based quality systems documentation. Display report writing capabilities and an ability to work within timelines. Be organized and capable of demonstration of ALCOAC. Review informed consent forms, investigator site files, and source documents for accuracy.
• Inspection readiness: promote a culture of inspections readiness and continuous improvement. Be flexible to work with risk-based audit agendas and shifting priorities.
• Regulatory compliance: be knowledgeable of evolving GxP guidelines. Ability to critically think, eagerness to learn, and commitment to ensuring compliance. Knowledge of and able to interpret regulatory guidances such as 21 CFR Part 11/ Part 312, ICH GCP E6 (R3).
• Create and deliver training on Quality and Continuous Improvement activities.
• Support completion of RFP/RFI (Request for proposals/information).
• Learn and engage with digital technologies, including artificial intelligence.
• Support drafting for or conduct quality reviews of SOPs and provide support of SOP management.
• Provide AI project quality support, QC and consultation.
• Support other activities related to the management of QMS and accuracy of data.
• Support GxP and non GxP quality issues and/or projects needing quality consultation and support

Requirements

• A bachelor’s degree is preferred with a minimum of 1-3 years’ experience in clinical research-related quality assurance or compliance roles or clinical auditing.
• Clinical trial experience for a site, site network or CRO is required.
• Knowledge of GCP auditing techniques is preferred but may be transferable through other work experiences across GxP auditing, quality control, or five or more as a clinical research coordinator with quality related experiences.
• Certification as a clinical auditor is a plus but not required.
• Ability to work independently, remain objective, and manage multiple assignments and competing priorities.
• Ability to remain flexible and work in evolving regulatory environments and understand different quality frameworks for different programs or service lines across our company portfolios.
• Strong communication skills to develop collaborative working relationships and support sponsor, client or regulatory communications to enhance the impact of quality support.
• Strong interest in clinical research and health services, including knowledge of clinical trial site operations, protocol deviation management, regulatory frameworks and sponsor perspectives.
• Display an openness to innovative and compliant approaches to conducting research and health services activities.
• Ability to prioritize business objectives while maintaining high attention to detail.
• Technical proficiency required to work daily in eQMS and utilize various software and platforms across the business.
• Ability to communicate written and verbally and communicate findings effectively to senior leaders.

Tech Stack

• Google Cloud Platform

Benefits

• Paid Time Off (PTO) and Company Paid Holidays
• 100% Employer paid medical, dental, and vision insurance plan options
• Health Savings Account and Flexible Spending Accounts
• Bi-weekly HSA employer contribution
• Company paid Short-Term Disability and Long-Term Disability
• 401(k) Retirement Plan, with Company Match