Job Information
CRISPR Therapeutics Quality Site Head – Internal Manufacturing in Framingham, Massachusetts
Company Overview
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 partnerships 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 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 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 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 function at CRISPR’s internal manufacturing facility
Responsible for end-to-end Quality within the site, including FUSE qualification/validation, materials management, batch record reviews, change control, and deviations
Responsible for Product Disposition ensuring that intermediates and drug products are manufactured and tested in accordance with GMP and regulatory submissions, facilitate a Material Review Board when necessary
Chair the site Quality Review Board and establish quality metrics to demonstrate adherence to GMP regulations and CRISPR procedures
Collaborate with internal partners to enable compliant and successful manufacturing (e.g. technology transfers, validation, testing, and lifecycle management)
Maintain site inspection readiness and host Health Authority inspections
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 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.
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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