Job Title: Head of Quality Assurance

Location: New Jersey, close to Cranberry Township (On-site, 5 days a week)

Position Overview: We are seeking an experienced and dynamic Head of Quality Assurance to join the team. The successful candidate will be responsible for overseeing all aspects of quality assurance, ensuring that our products and processes meet the stringent standards required for clinical trials. This is a critical leadership role that demands a deep understanding of regulatory requirements, exceptional attention to detail.

Key Responsibilities:

• Develop, implement, and maintain a robust Quality Assurance (QA) program to ensure compliance with all regulatory requirements (FDA, EMA, ICH, etc.).
• Oversee the preparation and submission of regulatory documents, including quality reports and audits.
• Conduct regular internal audits and manage external audits to ensure continuous compliance with industry standards.
• Collaborate with cross-functional teams.
• Develop and maintain quality metrics and reporting systems to monitor performance and identify areas for improvement.
• Ensure timely resolution of quality issues and non-conformances, implementing corrective and preventive actions as necessary.
• Stay up-to-date with the latest industry trends, regulations, and best practices to ensure our QA processes are cutting-edge and effective.
• Foster a culture of quality and continuous improvement throughout the organization.
• Hold client and supplier audits

Qualifications:

• You must have experience with Clinical Trial Supply Packaging / Labelling experience.
• Minimum of 10 years of experience in Quality Assurance within the pharmaceutical or clinical trial supply industry.
• Comprehensive knowledge of regulatory requirements and quality standards (FDA, EMA, ICH, etc.).
• Proven track record of leading and managing QA teams in a fast-paced, high-stakes environment.
• Strong analytical, problem-solving, and decision-making skills.
• Excellent communication and interpersonal skills, with the ability to work collaboratively across all levels of the organization.
• Detail-oriented with a strong commitment to accuracy and compliance.
• Ability to work on-site in New Jersey 5 days a week.

This role will have the potential to grow with the company and potentially manage additional sites.