Director of Quality Control & Compliance

Cellectis Group; Raleigh (NC); On-site; USD 120,000 - 150,000; Full time

Job summary

A biotechnology firm in Raleigh, NC is seeking a Director of Quality Control to lead all QC activities supporting drug manufacturing. This role includes overseeing analytical, microbiological, and environmental monitoring programs, ensuring compliance with GMP regulations. The ideal candidate will have a Bachelor's degree in chemistry or a related field, with over 12 years of experience in QC, including 8 years in leadership. Strong problem-solving and leadership skills are essential, along with an understanding of regulatory inspection processes.

Qualifications

• Minimum 12 years of experience in pharmaceutical or biotechnology QC, with 8 years in leadership roles.
• Experience managing environmental monitoring and contamination control strategies in GMP manufacturing environments.
• Proven track record of regulatory inspection success and audit management.

Responsibilities

• Provide strategic leadership and oversight of all QC activities supporting drug substance and product manufacturing.
• Oversee analytical, microbiological, and environmental monitoring programs, ensuring compliance with GMP requirements.
• Develop and monitor QC performance metrics, identifying trends and driving actions to improve performance.

Skills

Leadership skills

Analytical techniques

Data integrity principles

Communication skills

Problem-solving skills

Education

Bachelor's degree in chemistry or related discipline

Advanced degree preferred

Job description

A biotechnology firm in Raleigh, NC is seeking a Director of Quality Control to lead all QC activities supporting drug manufacturing. This role includes overseeing analytical, microbiological, and environmental monitoring programs, ensuring compliance with GMP regulations. The ideal candidate will have a Bachelor's degree in chemistry or a related field, with over 12 years of experience in QC, including 8 years in leadership. Strong problem-solving and leadership skills are essential, along with an understanding of regulatory inspection processes.