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Associate Director, Quality Operations

If interested and qualified, please include Requisition # 2017-239 in the subject line when emailing resume to: careers@crisprtx.com.

For more information on CRISPR Therapeutics, please click here.

Position Summary

Reporting to the Director, 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.

Responsibilities

  • 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 / 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 cGMP, GLP & GCPs
  • 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

Minimum Qualifications

  • BS in Biological Sciences or related fields
  • Minimum 7-10 years’ relevant industry experience including at least 5 years in GMP Quality Operations
  • Knowledge in biologics drug substance and aseptic drug product manufacturing
  • Experience interacting with contract manufacturers and/or contract test labs is desirable
  • Demonstrated knowledge of Quality Systems and cGMP within an FDA-regulated environment
  • Knowledge of industry standards as applied to FDA GMPs, EU GMPs, and ICH guidelines
  • Excellent organizational and time management skills with a high level of attention to detail
  • Demonstrated knowledge of Quality Control
  • Strong analytical, problem solving and critical thinking skills
  • Excellent oral and written communication skills for effectively interfacing with internal and external organizations
  • Ability to handle multiple assignments in a fast-paced environment with changing priorities
  • Competency in MS Office and Adobe Acrobat
  • Ability to travel up to 20% of the time
  • Excellent communication skills, in both verbal and written form
  • Ability to influence others and work independently and in a team environment
  • Leadership, negotiation and conflict management skills
  • The following personal characteristics:
    • Self-starter and action-oriented
    • Self-confidence combined with humility in approach
    • Compassion and passion for patients
    • Able to assess risk and willingness to take controlled risks
    • A willingness and desire to be a team player
    • Culturally sensitive
    • Ability to assess complex issues and propose viable solutions

Preferred Qualifications

  • MS or advanced Biological Science or Engineering degree
  • Supplier Quality compliance auditing experience
  • Global Quality management experience
  • Experience with Gene or Cell Therapy Products

Competencies

  • Adaptability/Flexibility The ability to adapt to working effectively within a variety of situations; adapts enthusiastically to organizational change and to changes in job demands.
  • Communication and Teamwork – The ability to effectively express ideas in written and oral context. The ability to work co-operatively with others; the genuine desire to be a part of a team and contribute to organizational and team goals.
  • Effective Planning - Embedding discipline and thoroughness in our approaches.
  • Perseverance – Pursues tasks with energy, drive and initiative, even in the face of adversity.
  • Problem Solving – The ability to understand a situation, task or problem by breaking it down into smaller pieces using a systematic approach and to identify patterns and connections between situations that are not obviously related.
  • Relationship Building – Builds and maintains productive working relationships across a diverse spectrum of people.

If interested and qualified, please include Requisition # 2017-239 in the subject line when emailing resume to: careers@crisprtx.com.

For more information on CRISPR Therapeutics, please click here.