Position: Director of Quality Assurance and Compliance
Date: September 12, 2018
Job Summary: Longeveron LLC is an emerging cellular therapy company whose mission is to advance the field of regenerative medicine through the conduct of clinical trials of our novel stem cell products. We are seeking a dynamic and experienced professional to grow with our team as the Director of Quality Assurance and Compliance. This position is on-site at Longeveron’s headquarters in Miami, Florida. It is strongly preferred that the candidate have a background in biologic compliance with knowledge of 21 CFR 210 and 211, and 1271.
The Director of Quality Assurance and Compliance will manage the compliance function and is responsible for the batch records lifecycle throughout the manufacturing facility. Once documents have been created and approved, the incumbent will be responsible for tracking the lifecycle of batch records and documents to support manufacturing activities. This position also writes and reviews standard operating procedures (SOPs).
- Manages the compliance function and team for cGMP manufacturing compliance
- Ensures documentation including batch records, SOPs, logbooks, etc. that will be used throughout the manufacturing facility
- Adheres to internal/external guidelines, specifications, and regulatory requirements while creating and maintaining documentation
- Ensures that SOPs relevant to documentation (batch records, logbooks, etc.) are generated, maintained and available
- Tracks cGMP review and production close out of batch record documentation
- Positively interacts with internal associates to quickly and effectively resolve issues
- Addresses deficiencies and ensures completion of all follow-up actions, specifically those that target process fixes to maintain consistent resolutions to all batch review issues according to cGMP standards and company objectives
- Supports implementation of CAPAs, SOP revisions, quality improvement initiatives, operational excellence projects, etc.
- Develops processes for batch records including for issuing, tracking and reviewing batch records
- Develops and maintains metrics to track batch record turnaround time, errors and document related deviations
Education / Experience Requirements:
- Bachelor’s degree in Chemistry, Biology, Life Science or Engineering field
- 8+ years of broad cGMP production experience, with knowledge and understanding of process, documentation requirements and activities, preferably in an biologics manufacturing environment
- Well versed in compliance pertaining to 21 CFR 210 and 211, and 1271
- Experience with GCP in a commercial entity
- 3 years in a leadership role
- Extensive experience with GMP documentation management
Submission of published writing samples will be requested during the interview process. A writing test may also be required.
For further detail please contact: