The Director, Quality Assurance has primary responsibility for site Quality and overseeing the Quality Operations functions. Working closely with Manufacturing, Facilities, Operations, Regulatory Affairs, Materials Management and Quality Control and focus on development of systems to assure compliance to cGMP’s while meeting FDA and company goals in an efficient manner.
- Administration of quality team which manages the manufacturing, packaging, warehouse, and distribution.
- Administration of the quality team which manages the change control, investigations, audits, vendors internal/external, document control and training.
- Administration of the quality team managing the distribution of finished product and raw material.
- Interface with regulatory agency for site inspections
- Inform Sr. Management of any potiental compliance issues
- Oversite of environmental monitoring program
- Guide quality assurance personnel and utlitizing the resources on daily requirements and long term plans, including, assigning key performance indicatators(KPIs)
- Work with cross functional managment team to meet company objectives and site overall compliance to FDA inspections
- Manage cGMP compliance, training, and assigning job functions and ensure to meet organization expectation.
- Outlines objectives, identifying continuous improvement initiatives, monitors progress of deliverables, and provides support to Managers and Associates.
- Develops and implements procedures, programs and policies that support GMP operations and overall compliance strategy
- Serve as team leader in quality investigations and ensure corrective and/or preventative action plans to resolve potential product quality and compliance issues are appropriately implemented
Knowledge & Skills:
• Leadership development- supervision, management, and training
• Ensure all activities are in accordance with cGMP’s and SOPs
• Serve as company’s representative/host for regulatory audits and inspections (Primarily USFDA)
• Liaise with clients to ensure good relationships
• Prepare/review/ approve external and internal reports and propose and manage QA department budget
Experience & Education:
• Bachelor Degree in a Natural Sciences (i.e. Biology, Chemistry), Pharmacy, or Engineering.
• At least 10 experience in a quality assurance role in a cGMP-regulated environment.
• Strong Knowledge of GMPs (21 CFR 210/211, ICH Q7)
• Experience in Regulatory interface/Inspections (e.g. FDA, EU)