Quality Site Head – Internal Manufacturing (Executive Director)

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 to the Vice President of Quality Assurance, the Quality Site Head will play a key leadership role both at CRISPR’s internal GMP manufacturing site and within the Quality Assurance function as a whole.  The ideal candidate will lead by example to promote excellence in every aspect of internal GMP manufacturing operations as part of CRISPR’s mission to develop impactful therapies at the forefront of gene-editing technology.

Responsibilities

• Provide strategic direction and operational leadership for the site Quality Operations function at CRISPR’s internal manufacturing facility
• Responsible for the day-to-day leadership of direct reports
• Responsible for end-to-end Quality within the site, including FUSE qualification/validation, materials management, batch record reviews, change control, CAPA plans and deviations
• Responsible for Product Disposition ensuring that intermediates and drug products are manufactured and tested in accordance with GMP requirements and regulatory submissions, facilitate  Material Review Board meetings when necessary.
• Contributes data and insights for the GMP relevant Functional QMRs and Executive QMR key messages and content development.
• Collaborate with internal partners to enable compliant and successful manufacturing (e.g. technology transfers, process and system validation, QC testing, and lifecycle management)
• Establish and maintain site inspection readiness and host Health Authority inspections and routine audits
• Partner with GMP Operations to establish and maintain a self-inspection program
• Work closely with Quality Systems and Compliance, and External Quality Operations to advance all aspects of CRISPR’s GMP Quality processes
• Foster a Quality culture that values responsibility, innovation, continuous improvement, and personal accountability

Minimum Qualifications

• BS/MS in relevant scientific discipline and 15+ years of experience in a biopharmaceutical organization; including direct experience in Quality Assurance at a GMP manufacturing facility
• Expertise in FDA/EMA/ICH regulations and guidelines and a strong understanding of pharmaceutical product development lifecycle are required
• Able to simultaneously operate at both a strategic and hands-on level in a GMP environment
• Inclusive leadership skills and keen organizational awareness, enabling the development of strong working relationships with colleagues regardless of job level or function
• Ability to navigate a constantly evolving scientific and regulatory environment, and approach challenges with a proactive, ownership mindset
• Direct experience hosting Health Authority inspections
• Demonstrated ability to mentor staff and build an effective Quality team
• Self-awareness, integrity, judgment, and ability to remain calm and consistent under pressure
• Role model for Quality mindset, as well as the CRISPR CUREs values (Collaboration, Undaunted, Results Oriented, Entrepreneurial)

Preferred Qualifications

• Prior experience in the manufacture of cell and gene therapy products

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.

Due to the nature of their work, our manufacturing and lab-based positions are located fully on-site.

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.

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