Associate Director, Quality Operations
Reporting to the Director of GMP Quality, the Associate Director, Quality Operations will play a lead role in the development, implementation, and management of the GMP Quality Operations at CRISPR Therapeutics in accordance with applicable global regulatory requirements and CRISPR Therapeutics business objectives. This position will require up to 20% travel. This is a high visibility position with great impact potential.
- Lead oversight of external contract GMP manufacturing of CRISPR clinical drug products
- Review batch records and supporting documentation and approve products for release for clinical use
- Participate in/lead GMP deviation investigations in collaboration with CMO and CRISPR manufacturing staff
- Provide quality oversight of third party vendors, CMOs and Contract testing laboratories, including development and maintenance of quality agreements; and planning, conducting and documenting audits
- Assist in developing Quality Plans and metrics to monitor QMS effectiveness and communicating results to senior management via management review
- Maintain a contemporary knowledge of current industry trends, standards and methodologies as it relates to cGMPs
- Foster CRISPR Therapeutics Core Values when collaborating with cross functional teams
- Provide guidance and support to internal departments in the form of SOP reviews and/or ad-hoc requests
- Identify issues and implement solutions to ensure timelines are maintained
- Work collaboratively with internal and contractor technical and Quality departments to ensure appropriate product Quality is attained
- Develop project-specific procedures and processes
- Recommend and follow up on corrective actions
- BS in Biological Sciences, Analytical Chemistry, Chemical Engineering, or related fields
- Minimum 10 years of relevant industry experience
- Minimum of 5 years of experience in GMP Quality Assurance
- 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 Biological Science or Chemical Engineering
- Supplier Quality compliance auditing experience
- Global Quality management experience
- Experience in bioanalytical methods development, validation, and laboratory investigations
- Experience with allogeneic and autologous Gene/Cell Therapy Products
- 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 # 2018-368 in the subject line when emailing resume to: firstname.lastname@example.org.
For more information on CRISPR Therapeutics, please click here.