What are the responsibilities and job description for the Regulatory Compliance Manager position at Avantor?
Job Overview:
Avantor is a diverse, equitable, and inclusive culture committed to helping our employees grow and succeed. As a Pharmaceutical Quality Engineer Lead, you will be responsible for leading efforts in site quality assurance programs and improvement activities to ensure regulatory compliance with cGMPs, ICHQ7, IPEC guidelines, ISO regulations, and FDA requirements. Your key responsibilities will include identifying and implementing programs to ensure regulatory compliance, supporting CAPA, cGMP, Complaint Investigation and Response, ISO System, Stability, SPC, and Validation systems.
Key Responsibilities:
Avantor is a diverse, equitable, and inclusive culture committed to helping our employees grow and succeed. As a Pharmaceutical Quality Engineer Lead, you will be responsible for leading efforts in site quality assurance programs and improvement activities to ensure regulatory compliance with cGMPs, ICHQ7, IPEC guidelines, ISO regulations, and FDA requirements. Your key responsibilities will include identifying and implementing programs to ensure regulatory compliance, supporting CAPA, cGMP, Complaint Investigation and Response, ISO System, Stability, SPC, and Validation systems.
Key Responsibilities:
- Identify and implement programs to ensure regulatory compliance.
- Support CAPA, cGMP, Complaint Investigation and Response, ISO System, Stability, SPC, and Validation systems.
- Lead customer complaint investigations and manage audit activities.
- Provide GMP and GDP training to site personnel.
- Collaborate with supplier quality personnel to resolve quality-related issues.
- Partner with external customers, operations leadership, and plant operations teams to investigate and resolve process and product quality issues.
