Temporary QA Associate

Who We Are

Vial is a global tech-driven CRO providing next-generation clinical trial management services. The Vial CRO powers its drug discovery arm Battery Bio an AI-powered hyper scalable biotech. Battery Bio harnesses Vial's unique 90% lower cost structure to produce more affordable drug development with efficient streamlined clinical trials.

Our mission is to reimagine the drug discovery process to empower scientists to cure all human disease. We have assembled a talented team of clinical operators chemists and innovative thinkers to achieve this vision.

Vial is a San Francisco California-based company founded by Simon Burns in October 2020. Since our founding we have become a fast-growing company of 100+ employees with over $100 million in funding from esteemed investors including General Catalyst Box Group and Byers Capital.

Vial is rebuilding the infrastructure to advance research. By deploying technology at every step we are creating a more efficient future for drug discovery.

What You'll Do

The Clinical QA Associate will be responsible for the execution and oversight of GCP QA activities related to clinical trials. This involves working closely with Clinical Operations Engineering IT and other supporting areas/development teams to assure management in accordance with FDA regulations ICH-GCP SOPs and all other applicable regulations.

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.

Benefits (Not applicable to Contract or Temp Positions)

Competitive Equity Compensation

Health Dental and Vision Benefits

401k or RRSP Plan with Company Matching after first 90 days of employment

One time Remote Office Setup Stipend

Robust Paid Parental Leave

Remote-First Flexible Work Schedule

Unlimited Vacation