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
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