Vanguard Clinical, Inc. is a Contract Research Organization (CRO) headquartered in San Diego, CA, USA. Our mission is to bring innovation to clinical trial execution through passion, transparency, co-active communication, and integrity, to facilitate the successful development of life-changing medicines and therapies.
We are experts in clinical trial operations with a focus on Clinical Trial Management, CRO/Vendor Oversight, Trial Master File Management, Clinical Monitoring, Quality Assurance, Data Management and Study Startup. As a small company, we are highly adaptable, flexible, and transparent. Our unwavering integrity forms the foundation for our strong relationships both internally and as a partner to our Sponsor clients. Beginning with study development, we bring a “white glove service” approach to clinical trials. Our flexible approach and ongoing process development ensure efficiency and adequate resourcing, allowing us to respond rapidly to our clients’ needs as they evolve.
Our talented team is driven by passion and purpose, which has afforded us the opportunity to successfully lead clinical programs for pharmaceutical, medical device and biotechnology companies of all sizes in a variety of therapeutic areas. Our mission is to conduct clinical trials with outstanding quality on behalf of our clients to bring new drugs to market with the utmost integrity and confidence in the results.
Position Overview:
This is an exciting opportunity to join a growing organization in a fast-paced, collaborative environment. The Quality Assurance Manager provides independent quality oversight of internal and external clinical trial activities, records, and processes to ensure compliance with FDA regulations, ICH-GCP, internal SOPs, and other applicable regulatory requirements. The role supports quality objectives across the organization and contributes to achieving departmental and company goals.
Essential Duties & Responsibilities:
Maintains current knowledge of applicable GxP requirements and regulatory developments and communicates relevant impacts to QA leadership and stakeholders.
Supports the implementation, maintenance, and ongoing oversight of the Quality Management System (QMS).
Develops, reviews, and maintains SOPs and quality documentation to ensure compliance with applicable regulatory requirements (ICH-GCP, FDA CFR, et.c).
Provides client-facing Quality Assurance support, including development of quality documentation (e.g., SOPs, plans) and regulatory compliance guidance.
Establishes and maintains appropriate quality standards, parameters, and controls across clinical programs and quality processes.
Ensures ongoing compliance with applicable federal, state, local, and organizational regulations, guidelines, and policies.
Implements and supports Clinical Quality Assurance plans aligned with GCP standards, internal policies, and procedures.
Leads and supports inspection and audit readiness activities, including preparation, coordination, and participation in regulatory agency inspections.
Plans, conducts, and/or supports qualification, routine, and for-cause audits, and participates in the evaluation, qualification, and ongoing oversight of clinical vendors in accordance with company SOPs.
Oversees the management, tracking, and effectiveness of audit observations and CAPAs, including root cause analysis, trending, and escalation of systemic quality issues.
Evaluates quality trends and metrics to identify risks, support continuous improvement, and informs QA reporting to management.
Provides QA guidance to cross-functional teams through participation in study team meetings and interpretation of current regulatory requirements and best practices.
Conducts or supports QA review of clinical and regulatory documents, including protocols, Investigator Brochures, Clinical Study Reports, and integrated summaries, as applicable.
Supports the development and delivery of training materials and provides GCP and SOP-related training to internal stakeholders.
Collaborates with clinical teams to assess and investigate temperature excursions, deviations, and product complaints reported from clinical sites.
Participates in QA budget planning and resource forecasting activities.
Develops, monitors, and reports GCP quality metrics to support consistent quality performance across the organization.
Performs other duties and special projects as required.
Experience & Skills:
4 to 7+ years of experience in a related field required with supervisory experience a plus.
Must be highly organized and able to multi-task prioritizing simultaneous tasks.
Highly proficient with Office 365 (Outlook calendar, email, Excel, PowerPoint, and Word are a must).
Maintain confidentiality.
Exercises independent judgment and discretion.
Acute attention to detail.
Excellent communication skills.
Effectively work cross-functionally across the organization and externally.
Education:
Bachelor of Science degree in a scientific discipline from an accredited college or university is strongly preferred. Other bachelor's degrees with relevant industry experience will be considered.
Applicants with foreign transcripts/degrees must provide a U.S. equivalency report evaluation that indicates the degree to which the foreign coursework is equivalent from one of these evaluation agencies: https://www.naces.org/members.
Compensation Range:
Quality Assurance Manager: $85,000 - $125,000 annually + benefits package and annual performance bonus (Includes: health insurance, 401k retirement plan, and paid days off)
Senior Quality Assurance Manager: $125,000 - $175,000 annually + benefits package and annual performance bonus (Includes: health insurance, 401k retirement plan, and paid days off)
COVID-19 Vaccination: To protect the health and safety of our employees and to comply with client requirements, Vanguard Clinical may require employees in certain positions to be fully vaccinated against COVID-19, subject to reasonable accommodations or exemptions for religious, medical, or other legally protected reasons. Vaccination requirements will depend on the client site requirements. Proof of vaccination may be required, in accordance with applicable laws.
Vanguard Clinical is an equal opportunity employer for all applicants and employees. Vanguard Clinical prohibits discrimination and harassment of any type and affords equal employment opportunities to employees and applicants without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.