Assoc Director – Quality Assurance

Assoc Director – Quality Assurance

Requirements

• Demonstrates in-depth knowledge of Good Manufacturing Practices (GMPs).
• Demonstrates in-depth knowledge of QA principles, concepts, industry practices, and standards.
• Demonstrates excellent verbal, written and interpersonal communication skills.
• Experience as an effective people leader, driving high performance, developing talent, and resolving issues.
• Demonstrates some knowledge of Six Sigma tools, Define-Measure-Analyze-Improve-Control (DMAIC) methodology, performance measures and quality improvement approach.
• Demonstrates working knowledge of Risk Management tools (e.g., Hazard Analysis and Critical Control Points (HACCP) and / or Failure Mode Effects Analysis (FMEA)).
• 10+ years of relevant experience in a GMP environment related field and a Bachelor’s degree in science or related fields.
• OR 8+ years of relevant experience in a GMP environment related field and a Master’s degree in science or related fields.

Responsibilities

• Manages QA personnel responsible for batch review and lot disposition activities, including organizing and prioritizing group tasks, performing training, and writing performance reviews.
• Performs a wide variety of activities to ensure compliance with applicable regulatory requirements. Ensures compliance with current Good Manufacturing Practices (GMPs).
• Acts as an initial point of business escalation and provides guidance to staff on path-forward options.
• Participates in developing Standard Operating Procedures (SOPs) to ensure quality across internal and CMO operations related to Packaging and Labeling.
• Ensures that the quality of products conform to established standards and agency guidelines.
• Works directly with operating entities to ensure that inspections, audits and statistical process control analyses are conducted on a continuing basis.
• Participates in compliance audits as required. Interfaces with contract manufacturers to address performance or compliance issues.
• May interface with regulatory agencies as required.
• Writes and/or implements changes to controlled documents (e.g., SOPs, work instructions) as needed.
• Some positions at this level may specialize in transferring and driving quality initiatives across CMO organizations – this would include areas like CMO technology transfer, CMO process improvement, etc.

Preferred Qualifications

No preferred qualifications provided.