Description

Job Description:

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 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.

Job Summary

The Manager/Senior Manager, Quality Validation is responsible for supporting the Validation and Compliance Program at the CRISPR Therapeutics GMP facility located in Framingham, MA.

Responsibilities

As part of the Site Quality Assurance Team, this position is responsible for:

• Lead commissioning activities for facility/utilities and onboarding of new equipment to be installed in support of GMP operations.
• Reviewing and Approving Validation Lifecycle documentation; User Requirements, Functional Requirements Specifications, Design Specifications/Qualifications (DQs), Installation Qualifications (IQs), Operational Qualifications (OQs) and Performance Qualifications (PQs)
• Supporting the development and implementation of processes aimed to support a compliant, robust and sustainable lifecycle for; facilities/utilities and equipment, computer systems, shipping, analytical methods, cleaning and process.
• Author/Lead development of controlled documents such as policies, processes, and procedures associated with governing the validation program.
• Lead the implementation of validation/qualification strategies and serve as a Subject Matter Expert.
• Performing gap analyses on processes, systems, and practices and recommending and implementing corrective actions and improvements including requalification/revalidation exercises.
• Approving preventive maintenance/calibration, work orders for facilities/utilities and equipment.
• Leading deviations, investigations, CAPAs, and Change Controls associated to facilities/utilities and equipment.
• Reviewing and approving; deviation investigations, Corrective and Preventative Actions (CAPAs), Change Controls and Laboratory Investigations.
• Ensuring CRISPR's facilities/utilities and equipment processes are maintained in a state of inspection readiness.
• Participating in supplier qualification audits and supporting internal audits and regulatory inspections.
• Gathering, preparing, and reporting relevant Quality Metrics.
• Key internal partners include Quality Assurance, Manufacturing, Facilities, Quality Control, MSAT and Supply Chain.

Minimum Qualifications

• Bachelor of Science with experience in qualification, validation or compliance in a highly regulated GMP regulated environment.
  • Manager: 8+ years of relevant experience
  • Senior Manager: 10+ years of relevant experience
• Experience in the development, execution, and approval of DQs, IQs, OQs, and PQs is preferred.
• Experience in deviation investigation, corrective action and change control is expected.
• Proficiency with environmental and utilities monitoring principles.
• Experience with implementation of electronic system(s) to ensure compliance.
• Excellent written and verbal communication skills with the ability to communicate cross-functionally.
• Innovation and strategic compliance skills including identification and implementation of best practices.
• Ability to organize and prioritize workload to meet deadlines and company's objectives.
• Ability to work independently and within cross-functional teams.
• Ability to mentor less experienced staff members.

Preferred Qualifications

• Prior experience in cell and gene therapy

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.  

Manager: Base pay range of $122,000 to $138,000+ bonus, equity and benefits

Senior Manager: Base pay range of $140,000 to $160,000+ bonus, equity and benefits

The 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