EXECUTIVE – TM – QUALITY & LAB COMPLIANCE

Key Responsibilities: Roles and responsibilities include, but are not limited to the following: Develop, implement, and manage SOPs, work instructions, and compliance policies in support of GLP, GCP, ISO 13485 and CLIA/CAP lab operations. Ensure that record keeping is complete, and records are maintained appropriately by Translational Medicine lab staff. This includes ensuring the requisite standards are applied based on the intended use of the lab. Conduct regular internal diligence reviews and support internal audits to promote compliance in the labs. Assists with preparation for external audits and any required follow-up. Responsible for documenting corrective actions and developing plans to prevent future errors and improve processes. Prepares reports for periodic reviews of key quality and performance indicators across the labs. Ensures that correct training is assigned to the proper / relevant individuals Collate metrics on compliance and identifies ways to improve adherence to training plans. Assists in ensuring that employee qualifications and job descriptions (Employee Job Profiles) are maintained and updated on the required basis. Strive to continuously improve lab quality and productivity simultaneously.