Director of Clinical QA

Job not on LinkedIn

November 20

Apply Now

Receive Emails with Similar Jobs

Loyal

WebsiteLinkedInAll Job Openings

Healthcare Insurance • Artificial Intelligence • SaaS

Loyal is a comprehensive digital healthcare platform that integrates various touchpoints for patients and providers. Their solutions include data management, digital engagement, CRM campaigns, self-scheduling, and conversational AI, which are designed to optimize healthcare operations, improve patient engagement, and enhance care search and scheduling. Loyal focuses on making healthcare seamless by unifying provider and location data, managing reputation and directory listings, and offering robust machine learning and natural language processing capabilities to improve healthcare outcomes. The platform facilitates improved communication and retention through omni-channel engagement and feedback analysis, serving prominent healthcare organizations to streamline operations and drive better patient experiences.

51 - 200 employees

⚕️ Healthcare Insurance

🤖 Artificial Intelligence

☁️ SaaS

📋 Description

• Lead the design and execution of the Clinical Quality Assurance strategy to ensure GCP compliance across all studies. • Oversee and manage the clinical audit program, including investigator site audits, vendor audits, and internal process audits. All sites that are to be used for GLP/GCP work should be audited prior to conducting regulated work. This includes development of GLP and GCP facility audit documents. • Develop, implement, and maintain policies, SOPs, and training programs to support compliance with global regulations (FDA, EMA, VICH-GCP, etc.). • Partner with Clinical Operations, Regulatory, and other cross-functional teams to proactively identify and mitigate quality and compliance risks. • Provide quality oversight of vendors and CROs to ensure adherence to contractual and regulatory obligations. • Support clinical trial inspections (FDA, EMA, etc.) and lead preparation and response activities. • Analyze audit trends and inspection findings to develop continuous improvement initiatives. • Serve as the company’s subject matter expert (SME) on GCP-related quality and compliance matters. • Review all protocols, data and reports being generated under GLP/GCP. This includes data collection & interpretation. Prepare quality summaries as required. • Manage and respond to adverse events (with clin ops) for drug products in the clinic and beyond. • Lead, mentor, and develop a team of quality professionals. • Help with training new regulatory hires or contractors as appropriate. • Building a Quality Assurance Unit process and team as Loyal grows and requires expansive quality assurance infrastructure. • Prepare for Quality aspects of Global expansion. • Develop, implement, and manage systems to ensure consistency and quality across all Loyal teams. Examples: Research Ops/Dog Ops QA: Standard checklists/docs for study design, study startup, data review, study closeout, and final reports. People Ops QA: Standard checklist for new employees (science-based section, ops-based section). • Supporting commercial recalls, adverse events, customer complaints. • Being the face of the company for Clinical Quality matters when interfacing with regulatory authorities.

🎯 Requirements

• Bachelor’s degree in STEM or related field. • Minimum 10+ years of experience in Clinical Quality Assurance or Clinical Operations (must be in Animal Health), with at least 5 years in a leadership role. • Experience in one of the following regulatory compliance practices: GCP (VICH) or GLP practices (prefer GCP) in animal health pharmaceuticals (not human health). Willing to familiarize yourself with regulatory practices in which you may not have experience. • Track record of success and a broad understanding of current QA practices as they apply to animal health clinical trials and quality assurance. • In-depth knowledge of FDA-CVM and other international clinical research regulations. • Proven experience in managing audits, inspections, and CAPA systems. • Strong leadership, communication, and collaboration skills. • Ability to influence cross-functional teams and drive a culture of quality and compliance.

🏖️ Benefits

• Full-coverage health insurance — medical, dental and vision — for you and your dependents • $1,000 home office equipment stipend • $1,200/year learning budget for books, courses, etc. • $250/month wellness budget for gym, cleaners, spa, food, etc. • All 3-day weekends are turned into 4-day weekends 🎉 • Unlimited vacation and paid holidays • Paw-ternity leave — adopt a dog and get a day off with your new family member 🐶 • Competitive salary • Company equity options grant for new hires