Senior Director, Quality Systems

Company: CRISPR Therapeutics
Location: Cambridge
Posted on: May 12, 2022

Job Description:

CRISPR Therapeutics is a leading gene editing company focused on developing transformative gene-based medicines for serious diseases using its proprietary CRISPR/Cas9 platform. CRISPR/Cas9 is a revolutionary gene editing technology that allows for precise, directed changes to genomic DNA. CRISPR Therapeutics has established a portfolio of therapeutic programs across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine, and rare diseases. To accelerate and expand its efforts, CRISPR Therapeutics has established strategic collaborations with leading companies including Bayer, Vertex Pharmaceuticals and ViaCyte, Inc. CRISPR Therapeutics AG is headquartered in Zug, Switzerland, with its wholly-owned U.S. subsidiary, CRISPR Therapeutics, Inc., and R&D operations based in Cambridge, Massachusetts, and business offices in San Francisco, California and London, United Kingdom. Job Summary Reporting to the Vice President of Quality Assurance our ideal candidate will own, manage and continually improve the Quality Management System with the goal of maximizing efficiency, effectiveness, and compliance with all applicable GxP (GLP, GCLP, GCP, GVP, GMP, GTP) regulations through proactive planning, high-quality training programs, and system health metric reporting. Responsibilities

• Maintain/ Optimize the company Quality Management System and provide an on-going assessment of Quality Management System effectiveness via Quality Management Review and other established monitoring programs / processes.
• Identify, prioritize, and execute quality improvement efforts to continually improve efficiency, effectiveness, and compliance with applicable GxP regulations. This may include leading system / process engineering or redesign efforts, as required.
• Engage and enable the development of site objectives (e.g., annual improvement priorities), ensuring that Quality Plan initiatives are properly planned, prioritized, resourced, executed, and evaluated for effectiveness.
• Direct the Quality Management Review process, including oversight of analysis and reporting of Quality System performance metrics
• Identify compliance gaps and improvement opportunities to inform the Company Quality Plan and/or Inspection Readiness plans
• Lead and provide oversight of the Investigation/CAPA system, ensuring clear root causes are identified and addressed with robust corrective actions, and where appropriate, global actions to prevent reoccurrence of the event. Ensure that actions are assessed for effectiveness post-implementation.
• Oversight for company wide GxP training programs, ensuring a clear line of sight from training requirements to specific GxP job functions aligned to job descriptions. Implementation of company wide GxP training in alignment with the company Quality Plan.
• Responsible for the GMP documentation system
• Provide guidance and oversight of the Change Control System
• Oversight of the Quality Risk Management and Knowledge Management Program
• Implement Company commercial complaint system
• Provide input to regulatory inspection responses to ensure systemic, comprehensive solutions address root causes and prevent recurrence.
• Foster a culture that values innovation, continuous improvement, and personal accountability in interactions with direct reports and others.
• Work across departments and functions to harmonize workflow, identify responsibilities and optimize cross-functional team member participation.
• Mentor, and coach staff to continually develop and enhance skills.
• Foster a culture of Quality Minimum Qualifications
  • Bachelor's Degree in Biology, Chemistry, Engineering, or related Scientific field
  • Minimum 15 years of Commercial cGMP/Quality leadership experience in Pharmaceuticals or Biotech. -
  • Complex analysis of business impacts/scenarios, including risk management, Quality Systems for Clinical Operations, internal and external manufacturing.
  • Excellent understanding of Quality Systems requirements - prior experience in leading Quality Systems & executing GMP Investigations, CAPA, Change Control, Training, Complaints, Product reviews.
  • Sound understanding of Documentation Systems, SOP Architecture and the relationship to the Quality Manual, Compliance, and training of staff.
  • Sound understanding of regulated activities, health authority expectations, and GxPs
  • Experience in hosting and managing Regulatory Inspections
  • Experience developing and executing large-scale organizational change, including change management strategy and planning.
  • Ability to design and implement global business processes/policies with a critical thinking approach and enterprise mindset.
  • Proven ability to understand complex processes/problems and facilitate coach teams to optimal solutions
  • Proven experience managing/influencing stakeholders across a broad spectrum of GxP topics.
  • Excellent organizational awareness (e.g., research & development, commercial manufacturing, interrelationship of departments, business priorities), including significant experience working cross-functionally and in global, cross- cultural teams.
  • Strong interpersonal and communication skills, Strong oral/written and listening skills, Strong problem-solving skills
  • Self-awareness, integrity, judgment, vision, and adaptability are key Preferred Qualifications
    • Additional Quality Compliance training or certification such as CQA, CQM, or LSS
    • Cell and gene therapy experience CRISPR Therapeutics, Inc. is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law.

Keywords: CRISPR Therapeutics, Cambridge , Senior Director, Quality Systems, Executive , Cambridge, Massachusetts