Senior QA Leader - GMP & Regulatory Compliance

AstraZeneca; Durham (NC); On-site; USD 80,000 - 100,000; Full time

Job summary

A leading pharmaceutical company is seeking a quality assurance professional to oversee compliance in manufacturing and product release. This role requires a Bachelor’s Degree in Life Sciences and a minimum of 5 years experience in the pharmaceutical industry focusing on GMP. Responsibilities include mentoring project teams on regulatory standards, leading quality improvement efforts, and ensuring compliance through audits and assessments. Strong interpersonal and problem-solving skills are essential for success in this position.

Qualifications

• Minimum of 5 years of experience in pharmaceuticals/biotechnology.
• Knowledge of Quality Assurance, ICH, and FDA/EU GxP regulations.
• Ability to demonstrate independent judgment and risk management.

Responsibilities

• Lead quality assurance compliance efforts for Drug Substance and Product.
• Provide mentorship on regulatory standards to project teams.
• Support internal/external inspections and lead quality improvement projects.

Skills

Problem solving

Interpersonal skills

Team working

Communication

Education

Bachelor’s Degree in Life Sciences

Job description

A leading pharmaceutical company is seeking a quality assurance professional to oversee compliance in manufacturing and product release. This role requires a Bachelor’s Degree in Life Sciences and a minimum of 5 years experience in the pharmaceutical industry focusing on GMP. Responsibilities include mentoring project teams on regulatory standards, leading quality improvement efforts, and ensuring compliance through audits and assessments. Strong interpersonal and problem-solving skills are essential for success in this position.