We have a current opportunity for a Manager GMP Training Oversight (PA) on a permanent basis. The position will be based in the Greater Philadelphia Area. For further information about this position please apply.
Key Responsibilities:
- Oversee GMP training compliance and execution in pharmaceutical environments.
- Ensure training documentation adherence and employee comprehension.
- Assess and improve the training management system and records.
- Support development and management of the Quality Management System (QMS) for GMP manufacturing.
- Conduct gap assessments and update SOPs to meet standards.
- Assist in regulatory compliance, inspections, and filings.
- Utilize Quality Systems for reviews and approvals.
- Develop and deliver training programs (GMP, data integrity, etc.).
- Lead compliance improvement projects.
- Support internal audits and serve as a quality resource.
Key Qualifications:
- Bachelor's degree in a relevant discipline.
- 5+ years of Quality Assurance experience.
- Advanced knowledge of cGMP, ICH, FDA, EMA, and USP/EP guidelines.
