Head of Quality
Durham NC or Seattle WA
Tune Therapeutics is a cutting-edge biotechnology company founded by world-class leaders in epigenome editing. At Tune, we strive to develop paradigm-changing cell and gene therapies that leverage epigenetic programming for the treatment of devastating diseases. We are building a highly skilled and dynamic team with expertise that spans drug discovery through commercialization. We are passionate about the science of epigenetic editing and its potential to transform patient care.
We are looking for the Head of Quality who will establish and ensure compliance with Quality requirements, global regulatory and industry standards, internal standard operating procedures (SOPs), and federal regulations. In this role, you will build and evolve the Quality function that currently includes Quality Assurance, Quality Control, and External Quality. In addition, you will be responsible for attracting talents, providing technical guidance, and supporting their career development. Equally important, you will help shape and sustain an innovative and inclusive culture as a member of the Tune community.
Key responsibilities include:
- Establish the Quality vision for the company and promote Quality mindset.
- Build the Quality function to deliver Quality Management System and direct quality operations, including processes and procedures to support GxP operations.
- Design, implement and maintain (GxP) QA and QC functions as well as the compliance infrastructure, including an SOP system, training programs, and internal and external audits.
- Drive decisions using science-based risk assessment.
- Effectively represent Tune Tx with external partners on Quality matters.
- Provide strategic insight to company short- and long-term planning. Develop and deliver Quality functional goals aligned with company strategy. Build and manage budget as appropriate.
- Recruit and develop experienced Quality professionals based on company needs.
The ideal candidate has strong leadership and communication skills and can thrive in a creative and dynamic environment. Required expertise and experience include:
- Advanced Degree in Science, Engineering, or related discipline required with a minimum of 15 years of experience in the biopharmaceutical industry.Experience in cell and gene therapy is a plus.
- A minimum of 5 years leading pharmaceutical Quality Assurance, Quality Systems and/or Quality Operations; all phases of drug development experience is a plus.
- In-depth understanding and application of industry standards, global regulations, and guidelines.
- Strong knowledge of manufacturing process and technologies, analytical methods, and control strategy.
- Effective communication and stakeholder management skills through influencing and interpersonal negotiation.
- Direct experience managing/working with third parties.
- Demonstrated ability to build, develop, and lead a team of quality professionals in support of corporate goals.
Explore Passionately. Innovate Boldly. Execute Selflessly. Come bring the song to life!