What are the responsibilities and job description for the Quality Assurance Lead position at Genus PLC?
Salary
Job Description
You will oversee all aspects of compliance, quality control, and stewardship through the discovery, development, launch, and post-approval stages of Genus products. This includes reviewing and approving QMS-related activities, collaborating with R&D and product development teams, and providing solutions and guidance on implementation of solutions for out-of-scope operational defects.
You will also conduct periodic facility inspections and record audits of regulated analytical laboratories and production barns, determine compliance, and serve as the primary point of contact and representative of the Company for FDA-CVM audits and facility inspections.
Requirements
You must have demonstrated experience in project management and compliance with regulations, excellent organizational and interpersonal skills, and the ability to work both autonomously and collaborate across teams and functional areas.
Benefits
Job Description
You will oversee all aspects of compliance, quality control, and stewardship through the discovery, development, launch, and post-approval stages of Genus products. This includes reviewing and approving QMS-related activities, collaborating with R&D and product development teams, and providing solutions and guidance on implementation of solutions for out-of-scope operational defects.
You will also conduct periodic facility inspections and record audits of regulated analytical laboratories and production barns, determine compliance, and serve as the primary point of contact and representative of the Company for FDA-CVM audits and facility inspections.
Requirements
You must have demonstrated experience in project management and compliance with regulations, excellent organizational and interpersonal skills, and the ability to work both autonomously and collaborate across teams and functional areas.
Benefits
