Senior QA Operations Leader - GMP & Quality Assurance

Guerbet; Raleigh (NC); On-site; USD 90,000 - 120,000; Full time

Job summary

Guerbet is seeking a QA Operations Sr. Manager in Raleigh, North Carolina to ensure quality leadership and oversight across site operations. This role involves managing QA processes in compliance with hygiene, safety, and regulatory standards, while promoting a strong quality culture and continuous improvement.

The ideal candidate should have a Bachelor's or Master's degree in a relevant scientific field and ten or more years of progressive experience in Quality Assurance within regulated environments. Our commitment to diversity and inclusion is paramount, creating a welcoming environment for all.

Qualifications

• 10+ years of progressive experience in Quality Assurance within a regulated pharmaceutical or biotech environment.
• Extensive experience in pharmaceutical or biotech manufacturing under GMP regulations.
• Strong experience in QA oversight of sterile manufacturing preferred.

Responsibilities

• Provide independent QA oversight across all operational activities, ensuring compliance with safety and quality standards.
• Drive timely investigations of quality events and oversee product release processes.
• Lead continuous improvement initiatives to enhance operational performance.

Skills

QA oversight of operations

GMP regulations

Leadership in QA teams

Quality risk management

Continuous improvement

Education

Bachelor’s or Master’s degree in Pharmacy, Microbiology, Biotechnology, Chemistry

Job description

Guerbet is seeking a QA Operations Sr. Manager in Raleigh, North Carolina to ensure quality leadership and oversight across site operations. This role involves managing QA processes in compliance with hygiene, safety, and regulatory standards, while promoting a strong quality culture and continuous improvement.

The ideal candidate should have a Bachelor's or Master's degree in a relevant scientific field and ten or more years of progressive experience in Quality Assurance within regulated environments. Our commitment to diversity and inclusion is paramount, creating a welcoming environment for all.