Director of Quality Assurance

Job Title: Director of Quality Assurance

Location: Burlington, NJ

Industry: Personal Care Packaging

Job Summary:

We are seeking an experienced Director of Quality Assurance to lead and oversee our Quality Department at our Burlington, NJ facility. The ideal candidate will have extensive experience in FDA, DEA, ISO, GMP regulatory compliance and a proven track record in quality management within the personal care packaging industry. This individual will be responsible for maintaining and enhancing our quality systems, ensuring compliance with regulatory requirements, and driving continuous improvement initiatives.

Key Responsibilities:

• Lead the Quality Assurance (QA) department, ensuring compliance with FDA, DEA, ISO, and GMP regulations.
• Oversee and manage all quality-related processes, including non-conformance, deviations, and other quality events.
• Develop, implement, and maintain CAPA (Corrective and Preventive Action) programs to address quality issues.
• Conduct Root Cause Analysis (RCA) for customer complaints and internal non-conformances to drive quality improvements.
• Ensure compliance with regulatory submission requirements, including NDA (New Drug Application) and BLA (Biologics License Application) presentations.
• Collaborate with cross-functional teams to develop and implement quality initiatives and ensure product integrity.
• Monitor and improve Quality Management Systems (QMS) to enhance efficiency and effectiveness.
• Establish and maintain quality policies, procedures, and standard operating procedures (SOPs).
• Lead internal and external audits, ensuring compliance with industry standards and regulatory requirements.
• Provide training and development programs for the QA team to enhance technical competencies.
• Ensure effective handling of customer complaints, deviations, and investigations to improve customer satisfaction.
• Stay updated on industry trends, regulatory changes, and best practices to maintain compliance and continuous improvement.

Qualifications:

• Bachelor’s degree in a relevant scientific or engineering discipline.
• Minimum of 7-10 years of experience in Quality Assurance within the personal care, pharmaceutical, or related industries.
• Proven experience managing a Quality Department and leading a team.
• Strong knowledge of FDA, DEA, ISO, and GMP regulations and compliance requirements.
• Experience with NDA and BLA regulatory submissions is a plus.
• Expertise in Root Cause Analysis, CAPA, non-conformance, and deviation management.
• Excellent leadership, communication, and problem-solving skills.
• Ability to manage multiple projects and prioritize tasks in a fast-paced environment.
• Experience leading regulatory inspections and audits.
• Strong analytical skills with a data-driven approach to decision-making.

Compensation & Benefits:

• Competitive salary commensurate with experience.
• Comprehensive benefits package including health, dental, and vision coverage.
• 401(k) plan with company matching.
• Paid time off and holiday benefits.
• Professional development and training opportunities.

If you are a highly motivated Quality Assurance professional with leadership experience and a passion for compliance and continuous improvement, we encourage you to apply for this exciting opportunity.