Quality Assurance Director
Koligo Therapeutics, Inc. is a biotechnology company commercializing and developing a range of cell therapy, three-dimensional (3D) bioprinted tissue and other regenerative medicine products for serious unmet medical needs.
Koligo’s first commercial product is KyslecelTM – an autologous pancreatic islet cell therapy. KyslecelTM is used in a total pancreatectomy with islet auto-transplant (TP-IAT) for the treatment of chronic or acute recurrent pancreatitis.
The Director of Quality Assurance (DQA) will be responsible for the development, implementation and management of Koligo’s quality systems and operations ensuring compliance with GCP, GVP, GMP, GLP, and other relevant regulations. DQA will oversee quality operations for both commercial and R&D production.
This position can be based in Louisville, KY or Cincinnati, OH (with expected travel between the two locations) and reports to the CEO.
- Establishes procedures and specifications affecting product quality and oversees the development of batch records, SOPs, and validation protocols
- Interacts with manufacturing, clinical, operations or other functional areas as they impact quality operations and ensures cross-functional completion of issues or actions identified
- Performs risk assessment and implements appropriate quality and process controls to ensure proper oversight of all production activities
- Performs internal audits and vendor qualifications to assure adherence to company SOPs and regulatory requirements, prepares written reports and follow up to resolve findings
- Provides oversight of ongoing training and support for the company
- Directs continuous improvement initiatives to accomplish compliance, productivity, cost effectiveness and enhanced efficiencies of processes and procedures as they pertain to quality
- Leads an internal audit program that is focused on prevention versus correction
- Leads the site inspection readiness program
- Is the primary contact with the FDA and leads FDA inspections at Koligo production sites.
- Prompt communication to superior and management of critical and/or non-compliance issues
- Complies with all applicable policies regarding health, safety, and environmental policies.
- Bachelor’s degree (advanced/graduate degree preferred)
- Documented training and/or certification in relevant quality fields (e.g. ASQ)
- At least 10 years of progressively responsible experience in Quality Assurance within the life sciences industry; 5 years prior management or leadership role preferred
- Previous experience with FDA inspections and interaction with FDA
- Experience in biologics or cell/tissue therapy production and development preferred
- Demonstrated track record in effectively managing and implementing GMP/GTP compliant quality systems
- Extensive working knowledge of GMP/GTP regulations
- Excellent interpersonal skills; builds effective interactions with a broad range of internal and external organizations, teams, and individuals
- Excellent verbal and written communication skills
- Ability to think critically and takes collaborative approach to problem solving
- Ability to work effectively in regulated and fast paced environment
- Demonstrates high level of professional integrity and trustworthiness with strong work ethics
- Ability to travel 20%