Clinical QA Manager
Posted on Thursday, September 28, 2023
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.
The Clinical QA Manager will be responsible for the development, maintenance and oversight of the GCP activities related to clinical trials. This involves working closely with Clinical Operations, Engineering, IT and other supporting areas/development teams, to help ensure active participation in continuous quality improvement activities. Provides Quality oversight to assure management in accordance with FDA regulations, ICH-GCP, SOPs, and all other applicable regulations and assists with tasks necessary to achieve company goals.
What You'll Do
- Develops and implements Clinical QA plans to meet GCP quality standards, policies, and procedures
- Collaborates with sponsors, vendors, and investigator sites to provide QA support and oversight while assessing compliance with local regulations, GCP/ICH requirements, and SOPs
- Lead qualification, routine and for-cause audits of vendors, investigator sites, as well as other clinical vendors to assess effectiveness of their QMS and compliance to approved clinical study protocols and contracts
- Conduct Trial Master File (TMF) audits
- Communicates Investigator Site and Clinical Vendor audit findings to audit stakeholders ensuring understanding 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.
- Participates in the evaluation and qualification of vendors
- Identifies potential systemic gaps and coordinates with the appropriate stakeholder to ensure timely remediation
- Lead/support continuous improvement activities and conduct internal training on Clinical Quality standards and regulations
- Leads the QA team and creates long-term strategic plans to ensure efficiency and compliance
- Conducts internal audits (systems, processes, vendors, computer system validation)
- Leverages technology to improve process efficiency, reporting and tracking
- Perform other related duties as assigned
What You'll Bring
- 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 vendor selection and software implementation
- Experience building scalable processes
- Proven ability to manage and develop people.
- Strong organizational skills, ability to multi-task, attention to detail, self-starter, ability to prioritize
- Excellent verbal, written communication, and presentation skills
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.
Competitive Equity Compensation
Health, Dental, and Vision
Paid Parental Leave