Associate Director, GxP Documentation and Training

Company Overview

Since its inception over a decade ago, CRISPR Therapeutics has transformed from a research-stage company advancing programs in the field of gene editing, to a company with a diverse portfolio of product candidates across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine, cardiovascular and rare diseases. The Nobel Prize-winning CRISPR science has revolutionized biomedical research and represents a powerful, clinically validated approach with the potential to create a new class of potentially transformative medicines. To accelerate and expand its efforts, CRISPR Therapeutics has established strategic partnerships with leading companies including Bayer and Vertex Pharmaceuticals. CRISPR Therapeutics AG is headquartered in Zug, Switzerland, with its wholly-owned U.S. subsidiary, CRISPR Therapeutics, Inc., and R&D operations based in Boston, Massachusetts and San Francisco, California, and business offices in London, United Kingdom.

Position Summary

Reporting into the Executive Director, Quality Systems & Compliance, the Associate Director, GxP Documentation and Training is a key member of our Quality team. This new role is accountable for advancing the internal documentation and training programs to achieve our corporate goals. This critical and highly visible role provides one with a unique opportunity serve as GxP Documentation and Training systems owner while managing a high performing team. This role will ensure compliance with applicable global regulatory requirements and alignment with company and quality objectives.

Responsibilities

• Ensure daily execution of documentation and training needs, across all CRISPR sites
• Oversee paper processes at our internal manufacturing site in Framingham, including issuance and archival of GMP records
• Establish program roadmap for digital enhancements, scaled solutions and enterprise growth for Documentation and Training services
• Own Veeva Quality Docs and ComplianceWire platforms
• Provide centralized service model for documentation and training coordination
• Design continuous improvement computer system initiatives for functionality and efficiency of Veeva Quality Docs and ComplianceWire
• Define and provide enterprise and functional metrics for documentation and training.
• Monitor, track and trend documentation and training requests
• Develop and oversee training program to include:
• Providing guidance on GxP instructional design and web-based training content
• Just-in-time quality training course catalog
• Co-Create Learning Governance in partnership with internal teams
• Support career and skill development for direct reports
• Support audits and inspections as required
  

Minimum Qualifications

• Minimum of 10 years GxP systems operation and management with 5 years of team leadership in the GxP specific systems
• Demonstrated expertise and technical knowledge depth in GxP systems
• Natural leader with a positive management style and ability to have fun, combined with excellent communication skills and unwavering ethics and integrity.
• Ability to reinforce company values and culture in day-to-day behaviors, management style, and expectations.
• Ability to lead by example, attract and develop talent, build partnerships and create a culture of collaboration and teamwork that fosters open communication, constructive conflict resolution and organizational flexibility.
  
  

Preferred Qualifications

• Experience with Veeva and ComplianceWire
• Expertise in cell & gene therapy
• Highly organized and detail oriented
• Ability to manage multiple projects/priorities
  
  

Competencies

• Collaborative – Openness, One Team
• Undaunted – Fearless, Can-do attitude
• Results Orientation – Delivering progress toward our mission. Sense of urgency in solving problems.
• Entrepreneurial Spirit – Proactive. Ownership mindset.
  
  

CRISPR Therapeutics believes in fostering a dynamic workplace that balances remote work flexibility with the benefits of in-person interactions. Our employees work at least three days on-site, creating a collaborative work environment, where we cultivate mentorship opportunities, increase cross-functional communication and offer opportunities for our employees to connect.

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.

To view our Privacy Statement, please click the following link: http://www.crisprtx.com/about-us/privacy-policy