CRISPR Therapeutics Senior/Executive Director, Quality Systems & Compliance in Boston, Massachusetts
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.
Reporting to the Vice President of Quality Assurance this role will be a key member of the Quality leadership team overseeing Quality Systems and Compliance. The ideal candidate will be able to collaborate with all parts of the organization to create and improve Quality programs to support multiple cell and gene therapy products. This position interacts extensively with internal and external stakeholders to establish and support policies, standards and procedures that enable CRISPR to comply with GxP regulatory requirements throughout the organization. This is a unique opportunity to create and execute a strategic quality plan for an innovative biotech company at the forefront of gene-editing technology.
Maintain and improve the Quality Management System and provide an on-going assessment of Quality Management System health and effectiveness
Create user-friendly and phase-appropriate Quality processes, that ensure compliance and can mature with the company in the future
Manage all compliance programs including Audits, Self-Inspection, Inspection Readiness, Compliance Investigations, and Data Integrity
Oversight of the GxP documentation system and global GxP training programs
Develops a process for identification and management of the top compliance risks across GxP functions, which will also include analysis of audit and inspection data.
Develop and report on quality performance metrics to drive continuous improvement
Direct the Quality Management Review process, including oversight of analysis and reporting of Quality System performance metrics
Identify compliance gaps and improvement opportunities to inform the corporate Quality Plan and/or Inspection Readiness plans
Manage and mentor the individuals in the quality systems and compliance teams to continually develop and enhance skills.
Foster a Quality culture that values innovation, continuous improvement, and personal accountability
Bachelor’s Degree in Biology, Chemistry, Engineering, or related Scientific field and a minimum 12 years of Quality leadership experience in Pharmaceuticals or Biotech
Comprehensive understanding of current GxP regulations and guidance, and ability to translate these expectations into practical solutions
Excellent understanding of Quality Systems requirements (Deviations, CAPA, Change Control, Training, Complaints, Product reviews and ability to implement these requirements in a phase appropriate manner
Excellent understanding of Documentation Systems, SOP Architecture and the relationship to the Quality Manual, Compliance, and training of staff.
Excellent organizational awareness and understanding of drug development (e.g., research & development, commercial manufacturing, interrelationship of departments, business priorities)
Experience in hosting and managing inspections
Superb interpersonal and communication skills
Ability to think strategically and influence others, and approach challenges with a proactive, ownership mindset.
Ability to develop strong working relationships with individuals in all functions and at all levels of the organization
Self-awareness, integrity, judgment, and ability to remain calm under pressure
Proven team leader with a track record of influencing/building/promoting a quality culture.
Flexibility to travel as required to accommodate the business needs.
Role model for Quality mindset, and the CRISPR CUREs values (Collaboration, Undaunted, Results Oriented, Entrepreneurial)
Prior experience in cell and gene therapy
Prior experience with Veeva Systems
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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