Orca is hiring a
Associate Director in Worldwide

Summary

The Associate Director, GCP QA at Orca Bio is responsible for managing and implementing a robust quality management system for clinical studies and preparing the company for regulatory inspections. The candidate should have a strong background in GCP with extensive knowledge of global regulations and standards (FDA focus).

Requirements

• Bachelor's degree is required (preferably in a scientific discipline) with 10+ years' experience in Quality Management related to GCP
• Extensive experience independently auditing clinical vendors and investigator sites

Responsibilities

• Proactively partners with relevant departments to implement compliant procedures and operations to ensure a robust quality management system for both the conduct of clinical studies as well as prepare the company to successfully commercialize clinical products
• Carries out the organization, preparation, coordination, and documentation of regulatory inspection readiness and serves as a key lead during regulatory inspections. Manages site and vendor preparedness, schedules coaching sessions with internal team members, follows-up on action items, maintains inspection tools
• Leads the clinical vendor qualification/audit program (maintains the vendor list, plans and schedules audits, conducts audits and generates audit reporting documentation). Leads the investigator site audit program (plans and schedules audits, conducts audits, generates audit reporting documentation, follows up with the site on action items stemming from the audit)
• Participates in the organization, preparation, coordination, and documentation of regulatory inspection readiness and serves as key QA contributor during regulatory inspections. Assists in site and vendor preparedness
• Assists with providing GCP compliance oversight of internal processes as well as those of CROs, vendors, and investigator sites
• Serves as the CAPA SME to process CAPAs in Master Control and provide guidance to cross-functional teams to ensure robust management and documentation of issues
• Reviews and provides input to clinical documentation (ICFs, protocols, etc.)
• Performs Clinical Study Report (CSR) Audits

Preferred Qualifications

• Cell therapy experience preferred
• Ideally, experience preparing for and hosting audits (sponsor audits); at minimum, participating in regulatory inspections

Benefits

Not specified