- BSc with 12+ management experience in the pharma industry
- Vendor management experience
- Knowledge of knowledge of GMP, FDA, and HPFBI
Director of Quality ComplianceToronto, ON, Canada
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DIRECTOR OF QUALITY COMPLIANCE
The selected candidate needs to have strong Quality Compliance knowledge as they will be leading the initiatives of the group. Additionally, this individually must have sound knowledge on HC and FDA guidelines and compliance requirements, must have experience in leading, and preparing for readiness of regulatory audits, and in addition to any follow up responses and close out requirements.
The position is responsible for the oversight of the Vendor Management Program and Contract Manufacturing Operation (CMO) compliance.
Background and Experience Required:
Minimum of B.Sc. Chemistry or other associated field
12-15+ years at the supervisory/management level in the pharmaceutical industry
Complete knowledge of pharmaceutical operations including USFDA environment
Complete knowledge of GMP, FDA, HPFBI and their associated guidelines
Problems associated with production issues that could range from scheduling problems to errors in production
The client evaluates the level of experience in relation to this role with the following questions:
1. Please describe your role in Regulatory Inspection readiness, conduct and responses to the agency?
2. Which Regulatory bodies have you been exposed to?
3. Since this role has oversight for the US Regulatory Compliance, please describe your exposure to management of the Field Alert Process (FAR) and Recall Management in the US
4. What has been your involvement in Recalls?
5. Please describe your Non-Conformance Investigation experience?
6. Please describe your Vendor Management experience?
Category: Biotechnology & Pharmaceutical
Reference ID: CA7677BM001463
Date Posted: 27/11/2019