Site Quality Leader — CGMP, FDA-Ready Operations

Guerbet; Raleigh (NC); On-site; USD 180,000 - 240,000; Full time

Benefits offered by this job

4 weeks of PTO

Insurance benefits start date of hire

Competitive 401K match

Tuition reimbursement program

Paid time off for volunteer opportunities

Job summary

A global leader in medical imaging seeks a Site Head of Quality in Raleigh, NC. This role involves overseeing Quality Operations for sterile products, ensuring compliance with regulations, and leading QA and QC teams. Responsibilities include developing quality systems, managing inspections, and fostering a culture of compliance. Candidates should have 12-15 years of experience in pharmaceutical manufacturing, strong regulatory knowledge, and excellent communication skills. Competitive benefits include PTO, insurance, and a 401K match.

Qualifications

• 12-15 years of leadership experience in sterile pharmaceutical manufacturing.
• At least 7 years in QA or QC leadership roles.
• Experience in FDA inspections.

Responsibilities

• Oversee Quality Assurance and Quality Control operations.
• Develop and improve Quality Systems.
• Establish Quality Culture aligned with CGMPs.

Skills

Leadership experience

Regulatory knowledge (FDA, EMA)

Communication skills

Problem-solving

Education

Bachelor or Master in biology, chemistry, microbiology, engineering

Job description

A global leader in medical imaging seeks a Site Head of Quality in Raleigh, NC. This role involves overseeing Quality Operations for sterile products, ensuring compliance with regulations, and leading QA and QC teams. Responsibilities include developing quality systems, managing inspections, and fostering a culture of compliance. Candidates should have 12-15 years of experience in pharmaceutical manufacturing, strong regulatory knowledge, and excellent communication skills. Competitive benefits include PTO, insurance, and a 401K match.