Director/Sr. Director, Quality
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.
Our team is growing, and we are currently seeking a Director of Quality to handle the oversight of internal GXP activities and to provide proactive quality management of contract organizations across the supply chain. Reporting to the Vice President of Regulatory Affairs, our ideal candidate will be a hands-on, collaborative Quality expert, with extensive experience in a GXP environment and in-depth knowledge of GMP.
Key Responsibilities Include
- Ensure overall Quality oversight, management, and coordination of GXP activities internally and with contract manufacturing, clinical supply chain, and testing laboratories, with focus on CMC manufacturing readiness for Phase 3/NDA quality compliance including vendor qualification and regulatory authority inspection readiness
- Apply substantial management experience to develop the Quality team, manage timelines to meet regulatory submission goals, and functionally align manufacturing development across teams, partnerships and corporate goals
- Develop and maintain internal Quality Management Systems (including quality policies & SOPs, management review, GXP training, internal and external audit program, CAPA management, and others) and ensures alignment with global policies and procedures
- Apply phase-appropriate flexibility to apply CMC quality standards for manufacturing and clinical development programs
- Effectively coordinate with internal and external partners to support the manufacture, packaging, release, distribution and return of preclinical and clinical trial materials.
- Collaborate with internal and external resources to author M3 eCTD documents for global submissions
- Coordinate with development and manufacturing teams to oversee the lifecycle of analytical and bioanalytical methods to support clinical development and marketing approvals
- Assure compliance of drug product, documentation, and data related to the manufacturing, packaging, labeling, and testing of IMP with GMPs, SOPs, M3/IMPDs, and INDs/CTAs/CTNs and NDAs/MAAs
- Create key quality metrics for tracking and trending data related to GXP activities; report metrics and significant quality incidents to senior leadership
- Perform other duties as required
- BS Degree in scientific discipline required, advanced degree preferred
- 10+ years of leadership experience
- Extensive experience in GXP environment and in-depth knowledge of GMP
- Proficient experience managing Quality Systems/SOPs with eDMS
- Exceptional organizational skills with the ability to prioritize deadlines, maintain focus and monitor progress on assigned tasks
- A creative, collaborative approach to problem solving
- Excellent written and verbal communication and presentation skills
- Occasional travel is required to perform vendor audits and oversee GMP manufacturing
- Thrives in a multi-tasked and hands-on environment
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.