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Quality Control Manager

2 months ago

New York, New York, United States Company Full time

The Quality Assurance professional will be responsible for directing and managing quality assurance operations to ensure adherence to cGMP, GMP, FDA regulations, and GLP standards. The ideal candidate will possess a robust background in quality management systems and a proven history of maintaining high-quality products and processes within a regulated environment. This position entails overseeing quality control teams, managing audits, and spearheading continuous improvement initiatives to uphold the highest standards of product quality and regulatory compliance.

Key Responsibilities:

  • Leadership and Oversight:
  • Lead and mentor a team of quality assurance professionals, including quality control inspectors and analysts.
  • Effectively schedule and allocate resources to meet production and testing demands.
  • Provide training and development opportunities to enhance team skills and expertise.
  • Regulatory Adherence:
  • Ensure compliance with cGMP, GMP, FDA regulations, and GLP standards across all activities.
  • Review processes and documentation to guarantee adherence to regulatory requirements.
  • Prepare for inspection readiness, including managing internal and external audits.
  • Quality Assurance and Control:
  • Oversee the establishment and maintenance of quality assurance programs, including inspection, testing, and validation processes.
  • Investigate and resolve quality issues, non-conformances, and customer complaints.
  • Conduct root cause analysis and implement corrective and preventive actions (CAPAs) as needed.
  • Documentation and Reporting:
  • Maintain and review quality documentation, including standard operating procedures (SOPs), validation protocols, and batch records.
  • Prepare and present quality reports, including key performance indicators (KPIs) and trend analyses, to senior management.
  • Continuous Improvement:
  • Drive initiatives for continuous improvement to enhance product quality and operational efficiency.
  • Implement and manage quality improvement projects, ensuring effective change management.
  • Cross-Department Collaboration:
  • Collaborate with other departments, such as Production, R&D, and Supply Chain, to support quality objectives and resolve quality-related challenges.
  • Participate in cross-departmental teams to support product development, process optimization, and regulatory submissions.

Qualifications:

  • Bachelor's degree in a relevant field (e.g., Chemistry, Biology, Engineering) or equivalent experience.
  • Demonstrated experience in a quality assurance role within a regulated industry, preferably with supervisory responsibilities.
  • Comprehensive knowledge of cGMP, GMP, FDA regulations, and GLP standards.
  • Strong understanding of quality management systems, quality control methodologies, and regulatory compliance requirements.
  • Excellent problem-solving abilities and the capacity to lead investigations and implement effective CAPAs.
  • Effective communication and interpersonal skills, with the ability to work collaboratively across teams.
  • Proficiency in utilizing quality management software and tools.
  • Detail-oriented with strong organizational and multitasking capabilities.

Preferred Qualifications:

  • Certification in quality management (e.g., ASQ Certified Quality Engineer or Certified Quality Auditor) is advantageous.