Senior Director of Quality and Compliance - Pharmaceutical Manufacturing - Olive Recruiting

The Senior Director of Quality and Compliance will oversee and lead the Quality Assurance and Compliance functions to ensure that all products are manufactured in accordance with applicable regulatory requirements and industry standards. This role requires comprehensive knowledge of Good Manufacturing Practices (GMP) regulations in both the United States and Europe, as well as experience in managing quality systems within a pharmaceutical manufacturing environment.

Responsibilities:

• Regulatory Compliance: Ensure that all manufacturing processes and products comply with U.S. FDA regulations, including Title 21 CFR, and European Medicines Agency (EMA) guidelines.
• Quality Management System (QMS): Develop, implement, and maintain a robust QMS that aligns with both U.S. and EU regulatory standards, ensuring continuous improvement and adherence to quality objectives.
• Audit Leadership: Lead internal and external audits, including FDA and EMA inspections, to assess compliance with GMP standards. Develop and oversee corrective action plans to address any identified deficiencies.
• Team Leadership: Manage and mentor the Quality and Compliance teams, fostering a culture of quality excellence and continuous development.
• Cross-Functional Collaboration: Collaborate with Manufacturing, Research and Development, and other departments to integrate quality and compliance considerations into all aspects of product development and production.
• Regulatory Intelligence: Stay abreast of changes in global regulatory requirements and industry best practices, and implement necessary updates to company policies and procedures.

Qualifications:

• Bachelor's degree in a scientific discipline; advanced degree preferred.
• Minimum of 10 years of experience in Quality Assurance and Compliance roles within the pharmaceutical industry, with at least 5 years in a leadership position.
• In-depth knowledge of U.S. and EU GMP regulations and guidelines.
• Proven experience in leading regulatory inspections and audits.
• Strong leadership and team management skills.
• Excellent communication and interpersonal abilities.
• Ability to work effectively in a fast-paced, dynamic environment.