Senior Director Operations – Quality Solutions

Key Responsibilities

• Implement mid-long term strategy
• Lead and direct quality resources for new product development, commercialized products, and manufacturing facilities
• Manage multiple plants
• Cascade Corporate Quality Goals at Entity level
• Support Global and Regional leaders to accomplish business strategies
• Integrate new businesses/acquisitions into Vantive Quality System
• Sponsor, plan and conduct special projects
• Communicate key measures, metrics and data
• Escalate potential product quality or safety issues
• Recommend risk mitigations/corrective action plans
• Provide Quality input into Sub-Business Strategies and Planning
• Ensure Quality Processes and Systems meet customer and regulatory requirements
• Drive consistency with Corporate processes and standards
• Monitor and meet key metrics and indicators
• Continuously improve compliance, cost and talent
• Monitor customer complaints
• Identify potential quality or safety issues
• Assess potential risks
• Recommend mitigation strategies/actions
• Effect field corrections, product removals, and corrective/preventative actions
• Partner with development teams for quality support on new product development projects
• Act as chief spokesperson and lead negotiator with Regulatory Authorities and Agencies
• Partner with Manufacturing to drive operational efficiencies and technical change
• Lead and direct Quality organizations
• Conduct special projects to drive Quality and Compliance improvement

Requirements

Education

Bachelor's Degree in sciences, engineering, or related discipline

Experience

15 or more years in Quality and/or manufacturing operations

Required Skills

• Technical experience in drug, biologics, and/or medical devices industry
• Strong leadership experience
• Global quality/manufacturing operations management
• Ability to travel globally at least 25%
• Expert in cGMP and ISO regulations
• Passion for continuous improvement
• Project management
• Supplier Quality Processes management
• Audit experience
• Operational experience in Change Control, complaint handling, CAPA processes, Internal auditing, Product Quality reviews, and/or validation
• Cross-cultural work ability
• Relationship building with senior regulatory agencies

Required Certifications

• Professional Project Management certification (preferred)