Description
Regulatory Quality Assurance (RQA) is an independent Quality audit function accountable to identify risks and non-compliance associated with Pfizer’s GxP regulated operations.
The Manager, GMP GDP Auditor will independently plan and lead complex audits of material suppliers, service providers, and Pfizer Country Offices, and participate in audits of low-complexity commercial or clinical manufacturing sites and contract manufacturers.
Key Responsibilities:
- Plan and lead complex audits
- Leverage AI tools to support targeted audit preparation and execution
- Engage with complex audits, including process audits
- Support and execute quality programs
- Apply GMP working knowledge to resolve issues
- Manage multiple stakeholders
Basic Qualifications:
- BS in pharmaceutical or natural sciences
- Advanced knowledge of global regulations (e.g., FDA, ICH, PIC’s, EMA, HC, ANVISA, TGA) and international standards (e.g., ISO, WHO)
- Comprehensive working knowledge of business concepts and quality operations
- Critical thinking and project management skills
- Technical writing skills
- Data analysis and recommendation-making skills
Preferred Qualifications:
- 5-7 years of experience in operations or auditing
- Working knowledge of data analytics and interpretation capabilities
- Expertise in vendor audits and at least one technology area
Physical and Mental Requirements:
- Primarily a field-based position requiring walking, observing, and lifting
Non-Standard Work Schedule, Travel or Environment Requirements:
- Ability to travel up to 40% of the time, including domestic and international travel