Quality Assurance Director
Koligo Therapeutics, Inc.
2113 State St.
New Albany, IN

About Orgenesis
Orgenesis Inc. is an international biotechnology company developing, manufacturing, and processing cell and gene therapy technologies and services. Orgenesis believes in unlocking the potential of personalized cell and gene therapies to address the world’s most challenging diseases in an efficient and cost-effective manner.

Koligo Therapeutics
Koligo Therapeutics, Inc. (“Koligo”) is a US regenerative medicine company developing and commercializing a range of tissue therapies for unmet medical needs. Koligo is unique in that, unlike most biotechnology companies, it has a product that is qualified for sale in the United States. Its first product Kyslecel® is an autologous pancreatic islet cell therapy used to treat chronic or recurrent acute pancreatitis, a debilitating and painful condition with few effective treatment options. Koligo commenced sales of Kyslecel® in November 2017. Short-term, Koligo is working on expanding its sales to a larger number of hospitals throughout the United States. Long-term, Koligo is developing a range of cell therapies, three-dimensional (3D) bioprinted tissue, and other regenerative medicine products.

Job Summary:
The Quality Assurance Director (QAD) is part of an onsite team dedicated to designing, developing, producing, and managing innovative medical products in the field of cell therapies and regenerative medicine. The QAD is responsible for implementation and maintenance of the quality system, promotion of regulatory requirement awareness throughout the organization, and coordination of activities relating to the quality system. This includes administering documentation and records within a paper-based and an electronic quality management system, performing Quality Control (QC) for product release, and informing the US Orgenesis VP of Quality Assurance of on-site quality issues. The QAD performs quality control functions during the production of Koligo’s main product, Kyslecel®. Limited travel may be required.

Job Duties:

• Plan, implement, and maintain the quality management system in accordance with 21 CFR Part 1271 and other quality systems as needed
• Generate and implement quality objectives throughout the Company
• Understand and communicate regulatory requirements to Senior Management and throughout the

Company

• Administer the paper-based QMS and the eQMS, to include validation and SOP generation
• Perform on-site recording of QMS data (collect/scan/email/post records)
• Manage and document quality issues (CAPA, Complaints, deviations, etc.) to include investigations
• Coordinate and support internal and external quality audits, to include regulatory audits
• Direct supplier qualification, maintenance, and auditing activities
• Perform quality training of personnel and contractors
• Assist in onsite office management (setting up team teleconferences, purchasing)
• Perform QC for product release and distribution activities, including inspection and data analysis
• Complete and maintain training in all standard operating procedures necessary to release the Kyslecel® product
• Prepare and support all paperwork, including Batch Production Records associated with each production run
• Work with others to ensure timely and appropriate cross-functional alignment for each assigned project
• Other duties as assigned

Essential Qualifications:

• Minimum of a Bachelor’s Degree in Science or Engineering
• Basic understanding of cGMP (current Good Manufacturing Practices) and CGTP (current good tissue practices) per 21 CFR 1271.
• Experience in a regulated industry preferred (medical device, pharmaceuticals, ISO 17025, etc.)
• Experience working with the principles and techniques of data analysis
• Ability to obtain comprehensive understanding of product specifications and functionality
• Strong computer skills, including Microsoft Office Suite (Word, PowerPoint, and Excel) and Adobe Acrobat
• Excellent interpersonal skills; builds effective interactions with a broad range of internal and external organizations, teams, and individuals
• Excellent written communication skills
• Ability to think critically and take collaborative approach to problem solving
• Ability to work effectively in regulated and fast paced environment
• High level of professional integrity and trustworthiness with strong work ethics

The ideal candidate would possess:

• Working knowledge of cGMP/cGTP regulations
• Direct working experience in the field of cell and tissue therapy preferred
• Direct working experience in a cleanroom environment
• Minimum 2 yrs managerial experience

Application:
To apply, email info@koligo.net. This is a full-time, onsite position with competitive pay and benefits based on experience. Submit resume and cover letter for consideration. Only qualified candidates with acceptable employment eligibility verification (I-9) will be considered. Visa assistance and relocation assistance are not provided. Koligo reserves the right to fill this position with an internal or external candidate at any time during the search. Koligo is not responsible for unauthorized job postings or submissions of resumes using external links/websites.

Job Type: Full-time

Pay: From $85,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday
• On call

Ability to commute/relocate:

• New Albany, IN 47150: Reliably commute or planning to relocate before starting work (Required)

Experience:

• cell therapy/regenerative medicine: 1 year (Preferred)

Work Location: One location