Head of Quality

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 Head of Quality is responsible for strengthening, further development and execution of AVROBIO’s quality assurance program and management systems, in support of all clinical development, pharmacovigilance, supply chain and manufacturing activities. He/she will direct GxP Quality related activities across the organization to support pivotal studies, global regulatory submissions (NDA/MAA, etc) and ultimately commercial launch of products. The Head of Quality will build and lead an internal team and supplement as necessary with external consultants/contractors to support QA activities, and they will provide leadership and guidance to the organization on global Quality matters.

Cambridge
Quality
Key Responsibilities
  • Ensure that AVROBIO Quality Management System meets standards expected by US and global regulatory authorities for research, development and ultimately commercial activities
  • Work closely with AVROBIO stakeholders to drive compliance with GxP regulations from Sponsor perspective
  • Write, review and revise SOPs related to clinical trials according to applicable global GxP regulations
  • Manages and supports internal audits of GxP functions and serve as a champion for continuous improvement in all aspects of total quality management through a well-trained team, streamlined business processes, and appropriate structured quality operations
  • Ensure products manufactured at CDMOs meet company quality standards and government regulations
  • Counsel, train and interpret quality requirements to ensure we and our GxP vendors maintain a state of compliance
  • Communicate significant quality risks that may impact product suitability or regulatory compliance in a timely manner to Executive Management
  • Serve as an escalation point for corporate quality issues
  • Serve as primary Quality contact in any audit by a regulatory authority and lead all audit communications with audit personnel from a regulatory agency
  • In collaboration with key stakeholders (Operations), provide both strategic and tactical Quality input and decisions related to innovative technologies, industry best practices, new regulations, and processes in end-to-end supply chain operations
  • Responsible for championing a partnership/customer focus approach in the organization ensuring all functions view the quality organization as a proactive collaborator and partner to ensure effective, safe, and compliant achievement of company goals
  • Drive quality into the organization (“culture of quality”) through proactive education, support, mentoring, coaching and consultation
  • Engage and energize team members through communication of goals, priorities, and other business critical information as well as recognizing and celebrating success and achievements
Minimum Requirements/ Qualifications
  • Bachelor's degree or advanced degree in related Life Sciences discipline
  • 15+ years of relevant experience in GxP, QA management or QA leadership positions in a Biotech or Pharmaceutical setting
  • Strong understanding of US FDA and EU EMA regulations and ICH guidelines for GMP manufacturing of cell and gene therapy products
  • Fundamental knowledge of US, EU and international regulatory standards and guidelines for the conduct of clinical trials
  • Experience interacting with regulatory health authorities at pre- and post-approval inspections
  • Strong analytical skills and report writing skills
  • Demonstrated team leadership and staff management and development experience
  • Must have professional communications skills, strong independent time management skills and the ability to manage multiple projects concurrently
  • Excellent communication, negotiation, and presentation skills
  • Maintains high ethical standards
  • Strong team orientation with a demonstrated ability to work both cross-functionally and in a matrix environment
  • Demonstrated ability to lead / managing vendors and others involved in Quality and Regulatory activities to meet corporate objectives
  • Excellent organizational skills and ability to work on multiple projects with competitive timelines
  • Strong attention to detail and respect for the need of accuracy of information
  • Excellent problem-solving and decision-making 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