• Requires a Bachelor’s degree in a science, engineering or related discipline and a minimum of 7 years of experience in Quality, Stability, Manufacturing and/or Regulatory Affairs.
• Significant relevant experience with Stability Program design, operations and/or management.
• In-depth knowledge of applicable Global regulatory compliance, and specifically Stability, requirements for drugs, cosmetics, biocides, and medical devices, including USFDA, Health Canada, TGA.
• Knowledge and experience with ISO 13485 and ISO 9001 requirements is required.
• Six Sigma certified black belt or green belt, ASQ-Certified Quality Engineer, Certified Quality Auditor, Certified Quality Manager and ISO 9001 or 13485 Lead Auditor Certification preferred.
General Expectations and Accountabilities:
• Ability to successfully lead teams by positively influencing people at all organizational levels.
• Ensures activities and items are in compliance with both company quality assurance standards and applicable government regulations, such as but not limited to EPA, GMPs, OSHA, and ISO requirements.
• Provide guidance on advanced Quality Engineering practices to cross functional team members.
• Demonstrate a strong spirit of partnership.
• Conduct all communications and transactions with the utmost integrity.
• Provides technical leadership in solving challenging technical problems related to quality issues and technologies.
• Develops, initiates, and implements new quality concepts, tools and strategies to improve business practices.
• Provides expertise guidance in specific field of knowledge.
• Assists with the transfer of knowledge of technical skills.
• Subject Matter Expert in Design Quality, Stability, Process Validation, and Risk Management.