What are the responsibilities and job description for the Director of Quality Assurance position at Engage Search Partners, LLC?
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 :
Compensation & Benefits :
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.
