Duration:
01 May – 01 September
Travel:
Expected (25%-50%)

Responsibilities

    • Lead qualification, routine and for-cause audits of vendors & investigator sites to assess effectiveness of their QMS and compliance to GCP, approved clinical study protocols and contracts
    • Conduct Trial Master File (TMF) audits
    • Conducts internal audits (systems, processes, vendors, computer system validation)
    • Communicates audit findings to audit stakeholders for visibility, as well as collaborating with auditees to ensure appropriate implementation of Corrective and Preventive Action Plans (CAPAs), addressing root causes
    • Maintains databases for Investigator Site audit observations and CAPAs; Tracks, reviews, approves, and assesses the adequacy of CAPAs. Provides input and supports observation and CAPA tracking for external Clinical vendors.
    • Collaborates with sponsors, vendors, and investigator sites to provide QA support and oversight to clinical studies while assessing compliance with local regulations, GCP/ICH requirements, and SOPs
    • Implement Clinical QA plans to meet GCP quality standards, policies, and procedures
    • Support continuous improvement activities
    • Support oversight/execution of training program to ensure appropriate training of all staff
    • Provide Quality oversight to deviation/Quality Incident investigations including root cause analysis and CAPA development and follow through
    • Perform other related duties as assigned

Requirements

    • 5+ years of experience in a pharmaceutical/biotech or CRO industry. Start-up experience preferred
    • Expert knowledge and understanding of ICH GCP and worldwide applicable regulatory requirements
    • Experience conducting internal, vendor and investigator site audits
    • Experience with software implementation
    • Strong organizational skills, ability to multi-task, attention to detail, self-starter, ability to prioritize
    • Excellent verbal, written communication, and presentation skills
$50 – $60 an hour
Why You’ll Love Working At Vial
Innate curiosity. At our core, we embody an insatiable curiosity. Our journey into the realm of clinical trials was ignited by a firsthand understanding of the challenges involved. This innate curiosity drives us to constantly innovate, seek fresh ideas, and bring our vision of reimagining clinical trials to life.
Fostering autonomy. Autonomy is our guiding principle. We firmly believe that when team members are entrusted with autonomy, they unleash their true potential. Our culture fosters an environment where each individual takes ownership of their domain, empowering them to make a profound impact.
The pursuit of mastery. We are dedicated to cultivating mastery. We understand the value of honing expertise in a craft. The pursuit of mastery, coupled with a deep sense of pride in one’s workmanship, fuels our unwavering commitment to tackle intricate challenges. At Vial, we foster a culture of highly autonomous professionals, each an expert in their field, collaborating on an immensely demanding endeavor together.
Move fast, stay humble. Our strength lies in agility and humility. We firmly believe that intellectual honesty and a nimble mindset are the pillars of success. By staying adaptable and open-minded to all solutions, we tackle obstacles head-on, remaining humble in the face of adversity. This enables us to surmount the hurdles that confront us at every twist and turn.
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