Associate Director, GMP Quality Assurance
Frequency Therapeutics (Nasdaq: FREQ) is a leader in the development of medicines designed to activate progenitor cells within the body to treat degenerative diseases. The company’s lead product candidate, FX-322, is a potential disease modifying therapy designed to regenerate damaged auditory hair cells to improve hearing function. In initial clinical studies of FX-322, the company observed meaningful improvements in key measures of hearing function in patients with sensorineural hearing loss, the most common form of hearing loss which impacts more than 90 percent of all people with hearing loss. The company recently completed enrollment of a Phase 2a study, with results to be shared in Q2 2021. Frequency’s progenitor cell activation (PCA) approach stimulates progenitor cells to create functional tissue and the Company is researching an array of additional degenerative diseases where PCA may be applied, including a pre-clinical program for remyelination in multiple sclerosis.
The Associate Director, GMP Quality Assurance will act as a subject matter expert on technical matters involving product examination, testing and disposition, quality investigations, and cGMP compliance.
This person will play a significant role in the continued development, execution, and monitoring of Frequency’s GxP Quality Management System. In this critical role, this person will play a significant part in the effective implementation of new quality system elements as they are introduced to Frequency’s GxP organizations.
The position will interact closely internally with 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 with CMOs and Contract Test Laboratories for the review and approval of master batch records, analytical methods, stability and validation protocol and reports.
- Review and approval of routine drug substance and drug product release and stability. documentation, including laboratory data, certificates of analysis, trending reports and any associated change controls, deviations, investigations and CAPA.
- Significantly contribute to the continued development and maintenance of the Frequency Quality Management system including authorship and implementation of quality system policies and procedures.
- Conduct vendor qualification including coordinating external GMP audits and tracking their progress through their lifecycle to closure.
- 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 GMP Quality operations.
- Strong understanding of FDA, EU, and ICH regulatory standards/guidelines.
- GLP and/ or GCP experience a plus.
- Demonstrated experience in GMP batch disposition.
- Demonstrated 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.