Director, Quality Assurance
Frequency Therapeutics is a leader in the development of medicines designed to activate progenitor cells within the body to treat degenerative diseases. The Company’s progenitor cell activation (PCA) approach stimulates progenitor cells to create functional tissue with the aim of developing disease modifying therapies. The Company’s lead product candidate, FX-322, is designed to regenerate auditory hair cells to restore hearing function. FX-322 is being evaluated in multiple ongoing clinical studies in patients with sensorineural hearing loss. The Company also is evaluating additional diseases where its PCA approach could create functional tissue, including multiple sclerosis.
The Director, Quality Assurance will act as a subject matter expert on technical matters involving product examination, testing and disposition, quality investigations, and cGMP compliance. In addition, they will play a significant role in the continued development, execution, and monitoring of Frequency’s GxP Quality Management System and take part in the effective implementation of new quality system elements, as they are introduced to Frequency’s GxP organizations.
The Director will have close internal interactions with Frequency’s Quality Control, Analytical Development, and Pharmaceutical Development teams, as well as external contract development and manufacturing organizations (CMOs).
- Represent Quality Assurance on Frequency product teams. Partner internally and with CMOs and Contract Test Laboratories for the review and approval of master batch records, specifications, analytical methods, stability and validation protocol and reports
- Review and approval of routine drug substance and drug product release and stability documentation, including batch records, laboratory data, certificates of analysis, trending reports and any associated change controls, deviations, investigations and CAPA
- ·Significantly contribute to the continued development, maintenance and compliance of the Frequency Quality Management system including authorship and implementation of quality system policies and procedures
- Oversee vendor management including vendor audit coordination, audit participation, audit report and responses approvals, performance monitoring and maintaining Quality Agreements.
- Provide oversight to the Change Control and Document Management systems
- Develop and conduct GxP training
- Perform other QA functions as necessary to maintain quality oversight of ongoing activities and quality initiatives
- Bachelor’s Degree in Scientific discipline
- 10+ years pharmaceutical industry experience in GxP Quality operations
- Strong understanding of FDA, EU, and ICH regulatory standards/guidelines
- Demonstrated experience in GMP batch disposition
- A successful track record implementing and maintaining effective, fit for purpose quality systems
- Proficient in the management of electronic quality management systems
- Previous experience working with external partners (vendors/collaborators) preferred
- Ability to travel up to 15%
Working at Frequency
At Frequency Therapeutics, we believe that we have the best chance to achieve our mission by creating an environment where our collective problem-solving and leadership skills are put to work, so collaboratively, we can solve some of the most complex challenges in medicine. We are focused on developing new treatments to potentially help millions of patients with novel therapeutics. This requires both a willingness to be audacious in our pursuits and relentless in our focus and commitment to research and patients. We look for individuals who are both highly skilled and self-aware, who are willing to challenge leadership and their colleagues, are entrepreneurial by nature and who are undeterred by uncertainty.
Please visit www.frequencytx.comfor more information.
We offer a competitive compensation and benefit package. For consideration, please submit CV and cover letter.