Director, Clinical Quality & Compliance Lead

Our culture is entrepreneurial, inclusive and caring. We're passionate about our work. And we embrace a pioneering spirit. Join us as we strive to develop innovative therapies with the power to give people with genetic diseases freedom for life.

Job Summary

The Director, Clinical Quality & Compliance Lead will serve as the business and process strategic leader responsible for planning, optimizing, implementing, managing, and continuously improving the following within the Clinical organization: Standard Operating Procedures (SOPs), systems, processes, communication, and infrastructure (internal and external) in support of AVROBIO clinical programs. This role will partner with the Clinical functions, Quality Assurance, Supply Chain, and other departments within AVROBIO as well as investigational sites and clinical vendors.

Cambridge
Research and Development
Jan 24 2021
Key Responsibilities
  • Identify and assess risks, gaps, and critical needs in terms of quality and compliance for the internal Clinical organization
  • Lead departmental initiatives aimed at innovation, process improvement, and efficiency
  • Partner with Quality Assurance on inspections, audits, and CAPAs as well as ensure state of inspection readiness within the Clinical organization
  • Author and manage SOPs, work instructions, and guidance documents
  • Identify, support, and track training opportunities to support compliance and process improvement within and across the Clinical organization
  • Contribute to the identification, testing, selection, and management of Clinical systems
  • Collaborate within Clinical to establish performance and quality metrics for studies and other initiatives and report on these
Minimum Requirements/ Qualifications
  • Bachelor’s Degree (Master’s Degree preferred) with a minimum of 10 years of experience in the pharmaceutical/biotech industry (sponsor or CRO) with:
    • Clinical Quality Assurance or Clinical Compliance role
    • Clinical/drug development in rare diseases/gene therapy (preferred)
  • Experience in leading and collaborating with the various clinical teams and functions to manage process improvement initiatives within timelines and budgets
  • Thorough understanding of clinical drug development, GCP, and familiarity with regulatory (FDA, EU, and other global regulations) requirements for the conduct of clinical trials, including investigator-initiated studies
  • Experience conducting GCP inspection readiness activities and/or hosting EMA and/or FDA inspections.
  • Strong project management skills with focus on continuous improvement
  • Interpersonal skills and the ability to collaborate within and across functions
  • Ability to meet deadlines and deal with complex and changing priorities while giving necessary attention, as required, to details
  • Proven skills regarding procedure writing and implementation
  • Strong written, oral communication and presentation skills
About AVROBIO

AVROBIO, Inc., a leader in lentiviral-based gene therapies, is a clinical-stage company developing disruptive therapies that have the potential to transform patients’ lives with a single dose. The Company is focused on the development of its gene therapy candidate, AVR‑RD‑01, in Fabry disease, as well as additional gene therapy programs in other lysosomal storage disorders including Gaucher disease, Cystinosis and Pompe disease. AVROBIO’s lentiviral platform has broad potential for other rare and non-rare genetic diseases. AVROBIO is headquartered in Cambridge, MA and has offices in Toronto, ON.

AVROBIO, Inc is an EEO employer