• Develop, implement, and maintain quality procedures and systems (electronic and manual) to ensure compliance with regulatory requirements and industry standards.
• Maintain and audit calendar and conduct regular audits to ensure compliance with quality standards.
• Ensure successful completion of audits and certifications by regulatory bodies.
• Manage the day to day onsite quality processes including incoming receipt and inspection, batch record management and issuance, label issuance, batch record review, supplier management, etc
• Communicate corrective action plans (CAPAs) to relevant stakeholders and ensure their implementation.
• Develop and maintain record systems for quality performance metrics, including global quality metrics.
• Provide oversight of the quality control laboratories including testing methodology, qualifications, stability and data integrity management and maintaining laboratory documentation to meet requirements.
• Work with cross functional teams to identify areas for improvement and implement processes to enhance quality.
• Stay up to date with industry developments and regulatory requirements and provide recommendations for continuous improvement of the quality program.
• Leads, develops, and continually upgrades skills and abilities of team.
• Promulgates culture of quality throughout the organization through interactions, teaching and by example.
• Accountable for risk identification and mitigation/brand protection.
• Supports sales and operational directives.
• Demonstrates both a process approach and data driven decision making/metric skills to improve company performance systematically and objectively.
• Actively manages the QMS to balance gain/capture of improvements with agility and lack of bureaucracy and waste.

• This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Other duties, responsibilities and activities may change or be assigned at any time with or without notice.

• Bachelor of Science or equivalent degree program in Engineering or other STEM field of study
• 8 years’ experience in Quality Assurance/Quality Control in a regulated industry and 5 years’ experience specific to management responsibility.
• Proven successful ability in the following areas:
  • Customer satisfaction/delight
  • Leadership of direct reports and cross-functionally
  • Influence without Authority
  • Internal relationship-building cross-functionally
  • Attention to detail
  • Technical / Professional / Industry Knowledge
  • Communications (written and oral both internal and with customer interfaces)
  • Data-Decision Making and Ownership
  • Development of systems, processes and metrics
  • Initiating Action
  • Contributing to Team Success
  • Follow-up and Closure
• Demonstrates excellent written and oral communications
• Must have professional demeanor; ability to use appropriate levels of tact, diplomacy, and discretion
• Demonstrated strong time management skills; able to handle multiple tasks, set priorities and meet deadlines
• Ability to resolve conflicts; work well under pressure, act quickly and decisively using sound judgment

As an Equal Opportunity Employer, ILC Dover is committed to a diverse workforce. We offer competitive benefits including medical, dental, life insurance, 401(k), PTO, and more.

Background Check & Drug Screening Required

E-Verify Used

EOE/AA Minority/Female/Sexual Orientation/Gender Identity/Disability/Veteran