Description
We are seeking a Regulatory Quality Assurance (RQA) GMP GDP Auditor to join our team. As an independent Quality audit function, RQA is accountable for identifying risks and non-compliance associated with Pfizer's GxP regulated operations.
The successful candidate will be responsible for:
- Independently planning and leading complex audits of material suppliers, service providers, and Pfizer Country Offices
- Participating in audits of low-complexity commercial or clinical manufacturing sites and contract manufacturers
- Performing initial and routine audits, and managing and leading with minimal oversight
- Leveraging AI tools to support targeted audit preparation and execution
- Engaging with complex audits, including process audits, or serving as a reviewer of low-complexity, outsourced audits
- Supporting and executing quality programs related to functional areas, specific vendor entities, and/or assessments
- Applying GMP working knowledge to resolve issues based on relevant SOPs, GMP GDP regulations/standards, and local regulations and standards
- Collaborating with RQA colleagues on cross-GxP audit plans as required
- Managing multiple stakeholders to synthesize feedback and take action with support from the Manager
The ideal candidate will have:
- A BS in pharmaceutical or natural sciences, or equivalent
- Advanced knowledge and understanding of global regulations and international standards
- Comprehensive working knowledge of business concepts and quality operations
- Ability to think critically and identify areas of greatest risk
- Proficient organizational and project management skills
- Technical writing skills
- Ability to identify trends within data and apply insights to make recommendations
- Specialization in at least one conventional technology (e.g., API, solid oral dosages)
Preferred qualifications include:
- 5-7 years of experience in operational or auditing roles
- Working knowledge of data analytics and interpretation capabilities
- Expertise in vendor audits and at least one technology area (e.g., MDCP, sterile biologics, small molecules, GDPs)
- Ability to function autonomously in a matrix model and in a team environment
- Fluency in both Japanese and English languages
This is a field-based position that requires walking, observing, and assessing quality and compliance risks. The successful candidate will be able to travel up to 40% of the time, including domestic and international travel.