Director / Senior Director, GCP Quality Assurance Lead (US/IL/EU)

About the role

The Director / Senior Director, GCP Quality Assurance Lead is responsible for overseeing the quality assurance processes and ensuring compliance with Good Clinical Practice (GCP), Good Validation Practices (GVP), and Good Laboratory Practices (GLP) guidelines. This role requires extensive experience in leading regulatory inspections and building robust quality management systems.

Responsibilities

• Oversee and manage all aspects of quality assurance including audit programs, corrective actions, and preventive actions.
• Lead and mentor a team of quality assurance professionals to ensure adherence to GCP, GVP, and GLP standards.
• Ensure compliance with regulatory requirements and conduct regular audits to identify and address non-compliance issues.
• Manage and lead regulatory authority inspections to ensure successful outcomes.
• Build and mature a quality management system in a small-to-mid-size pharmaceutical setting.

Requirements

• 10+ years of GCP QA experience within the pharmaceutical, biotechnology, or CRO industry.
• 3+ years of leadership or director-level experience in a biotech company.
• Demonstrated expertise in GCP, GVP, and GLP quality frameworks.
• Proven experience leading or managing regulatory authority inspections (FDA, EMA, MHRA, or equivalent).
• Experience building or significantly maturing a quality management system in a small-to-mid-size pharmaceutical setting.

Qualifications

• Master's degree in a relevant field such as Biomedical Sciences, Pharmaceutical Sciences, or related fields.
• Pharmaceutical Quality Management certification preferred.

Skills

• Strong leadership and mentoring skills.
• Excellent communication and interpersonal skills.
• Ability to work independently and as part of a team.
• Knowledge of regulatory requirements and auditing practices.
• Experience with quality management systems and software.

Benefits

This position offers competitive compensation, comprehensive benefits package, and opportunities for professional growth within a dynamic and innovative organization.

Pay

Competitive salary based on experience and qualifications.

Schedule

Full-time, remote position.