Associate Director, GCLP Quality Assurance
Reporting to the Head of Quality, this individual has primary responsibility for QA oversight of GCLP activities at CRISPR Therapeutics, its CROs, and third-party laboratories. The successful hire will ensure high quality and compliant transfer, validation, and execution of Bioanalytical methods and clinical sample management in support of clinical trials. This person will manage cross-functional relationships with internal and external stakeholders and will be the Quality Assurance representative on pre-clinical and clinical teams. The individual will work hands-on with internal and external partners. This is a high visibility position with great impact potential.
- Lead development, implementation, and maintenance of GCLP Quality Systems and SOPs; train and mentor staff on global GCLP regulations
- Participate in selection of contract GCLP laboratories and associated vendors
- Lead GCLP laboratories QA qualification audits, observations, development of appropriate corrective and preventive actions, and observation closure follow up
- Participate in bioanalytical methods transfer and validation at external sites
- Conduct contract laboratories monitoring; participate in out of trend and protocol deviations investigations
- Identify QA and compliance issues at testing laboratories; implement solutions to ensure timelines are maintained
- Lead and/or oversee consultant mediated audits
- Lead and manage GCLP Inspections on behalf of CRISPR Therapeutics
- Periodically report the state of GCLP Quality and compliance of clinical sample analysis to CRISPR Therapeutics management
- The candidate must be able to solve problems, communicate effectively, and trouble-shoot creatively
- BS in Biological Sciences, Analytical Chemistry, or related fields
- Minimum 10 years of relevant industry experience in sponsor companies or GCLP consultancies
- Minimum of 5 years of experience working as a laboratory Scientist/Analyst
- Minimum of 5 years of experience in GLP/GCLP Quality Assurance
- Experience in bioanalytical methods development, validation, and laboratory investigations
- Excellent knowledge of global GCLP regulations and industry standards
- Experience in managing health authority GCLP Inspections
- Proficient in study monitoring activities, clinical sample management,
- Knowledge of the infrastructure and operational characteristics of CROs and centralized services
- Demonstrated effective time management skills
- Demonstrated ability to work independently and in a team environment and seek resources as necessary
- Ability to assess complex issues, break into components, and propose viable solutions
- Demonstrated ability to lead and organize team meetings
- Ability to foster effective relationships with vendors, study directors, and colleagues
- Excellent communication, writing, and presentation skills
- Must be willing to travel domestically and internationally up to 20%
- MS or advanced degree in Biological Sciences with several years of experience working as a laboratory scientist
- Ten years in a QA GCLP regulated role
- Prior experience working at a CRO/third-party laboratory service provider
- Experience with cellular therapy drug development
- 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.
If interested and qualified, please include Requisition # 2018-366 in the subject line when emailing resume to: email@example.com.
For more information on CRISPR Therapeutics, please click here.