Quality Site Head

Crispr-Therapeutics-1; Framingham (MA); On-site; USD 230,000 - 250,000; Full time

Benefits offered by this job

Bonus

Equity

Benefits

Job summary

CRISPR Therapeutics, Inc. is recruiting a Quality Site Head to oversee the Quality function at its internal manufacturing site. You will drive a culture of quality, oversee GMP-compliant operations, and prepare for Health Authority inspections to ensure product disposition and compliant manufacturing processes.

The role requires 15-20+ years in biopharma QA, deep regulatory knowledge, and a proven track record in leading high-performing QA teams in GMP environments. On-site presence in the U.S.

Qualifications

• BS/MS in relevant scientific discipline and 15-20+ years in biopharmaceutical QA.
• Expertise in FDA/EMA/ICH regulations and product development lifecycle.
• Ability to operate strategically and hands-on in a GMP environment; inclusive leadership.

Responsibilities

• Provide strategic direction and operational leadership for the site Quality function at CRISPR’s internal manufacturing facility.
• Lead end-to-end Quality, including FUSE qualification/validation, materials management, batch record reviews, change control, and exceptions.
• Establish quality metrics to demonstrate adherence to GMP regulations and company procedures.
• Collaborate with internal partners to enable compliant and successful manufacturing (e.g., technology transfers, validation, testing, lifecycle management).
• Lead site inspection readiness, host audits and Health Authority inspections.

Skills

Quality Assurance

GMP Compliance

Regulatory Knowledge

Leadership

Audits & Inspections

Education

BS/MS in relevant scientific discipline

PhD preferred

Job description

Job Description:Company OverviewFounded over a decade ago, CRISPR Therapeutics is a leading biopharmaceutical company focused on developing transformative gene-based medicines for serious human diseases. The Company has evolved from a pioneering research-stage organization into an industry leader, marking a historic milestone with the approval of CASGEVY (exagamglogene autotemcel [exa-cel]), the world’s first CRISPR-based therapy, approved for eligible patients with sickle cell disease and transfusion-dependent beta thalassemia. CRISPR Therapeutics is advancing a broad and diversified pipeline across hemoglobinopathies, cardiovascular, autoimmune, oncology, regenerative medicine and rare diseases. The Company continues to expand its leadership in gene editing through the development of SyNTase editing, a novel and proprietary gene-editing platform designed to enable precise, efficient, and scalable gene correction. To accelerate and expand its impact, CRISPR Therapeutics has established strategic collaborations with leading biopharmaceutical partners, including 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.Position SummaryReporting to the Vice President, Head of Quality, 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.ResponsibilitiesFoster a Quality culture that values innovation, continuous improvement, and personal accountabilityProvide strategic direction and operational leadership for the site Quality function at CRISPR’s internal manufacturing facilityResponsible for end-to-end Quality within the site, including FUSE qualification/validation, materials management, batch record reviews, change control, and exceptionsResponsible for Product Disposition ensuring that intermediates and drug products are manufactured and tested in accordance with GMP and regulatory submissions,Establish quality metrics to demonstrate adherence to GMP regulations and CRISPR proceduresCollaborate with internal partners to enable compliant and successful manufacturing (e.g. technology transfers, validation, testing, and lifecycle management)Lead and maintain site inspection readiness, and host audits and Health Authority inspectionsWork closely with Quality Systems and Compliance and External Quality Operations to advance all aspects of CRISPR’s GMP Quality processesProvide leadership and management support for activities to drive a fast paced, highly efficient learning culture.Be a champion of a highly collaborative, transparent, data driven, make it happen’ culture.Minimum QualificationsBS/MS in relevant scientific discipline and 15-20+ years of experience in a biopharmaceutical organization; including direct experience in Quality Assurance at a GMP manufacturing facilityExpertise in FDA/EMA/ICH regulations and guidelines and a strong understanding of pharmaceutical product development lifecycle are requiredAble to simultaneously operate at both a strategic and hands-on level in a GMP environmentInclusive leadership skills and keen organizational awareness, enabling the development of strong working relationships with colleagues regardless of job level or functionAbility to navigate a constantly evolving scientific and regulatory environment, and approach challenges with a proactive, ownership mindsetDirect experience hosting Health Authority inspectionsDemonstrated ability to mentor staff and build an effective Quality teamSelf-awareness, integrity, judgment, and ability to remain calm and consistent under pressureRole model for Quality mindset, as well as the CRISPR CUREs values (Collaboration, Undaunted, Results Oriented, Entrepreneurial)Ability to execute and follow-through to completion.Strong leadership and an innate ability to collaborate and build relationships is critical.Preferred QualificationsPrior experience in the manufacture of cell and gene therapy productsProgressive Quality Control and/or Analytical Sciences experience, including method transfer, validation and routine release and stability testing operationsAdvanced degree such as PhD in Life Sciences or a related fieldCompetenciesCollaborative – Openness, One TeamUndaunted – Fearless, Can-do attitudeResults 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.Quality Site Head: Base pay range of $230,000 to $250,000+ bonus, equity and benefitsThe range provided is CRISPR Therapeutics’ reasonable estimate of the base compensation for this role. The actual amount will be based on job-related and non-discriminatory factors such as experience, training, skills, and abilities.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