Vaccines QA Director: GCP, FDA Audits & Global Lead

Integrated Resources Inc.; Cambridge (MA); On-site; USD 120,000 - 160,000; Full time

Job summary

Integrated Resources Inc. seeks a Director of Quality Assurance to lead vaccine clinical support auditing and compliance for a prominent pharmaceutical client. This role necessitates extensive experience in GCP and quality oversight for clinical trials, ensuring adherence to regulatory standards while providing strategic guidance. Ideal candidates will have a strong background in project management and excellent communication skills to manage cross-functional teams and external inspections.

Qualifications

• Minimum of 10 years in pharmaceutical, GCP-related Quality environment.
• 7 years indirect management in GCP Quality Assurance required.
• Certification such as ASQ Certified Quality Auditor preferred.

Responsibilities

• Ensure audits are conducted and compliance risks reported.
• Lead FDA audit preparations and responses.
• Develop strategic audit plans for vaccine programs.

Skills

Auditing Knowledge

Clinical Development

Communication skills

Negotiation Skills

Project Management

Organizational skills

Education

B.S. in Biology, Nursing, Pharmacy, or related scientific field

MS preferred

Job description

Integrated Resources Inc. seeks a Director of Quality Assurance to lead vaccine clinical support auditing and compliance for a prominent pharmaceutical client. This role necessitates extensive experience in GCP and quality oversight for clinical trials, ensuring adherence to regulatory standards while providing strategic guidance. Ideal candidates will have a strong background in project management and excellent communication skills to manage cross-functional teams and external inspections.