Director, Quality Assurance

Role Summary

Director, Quality Assurance overseeing the two NNPILP Emerging Technologies sites. Responsible for the Quality Assurance function and serving as the leading expert in quality, compliance, quality management systems (QMS) and regulatory affairs. Provide direction and coordinate activities of the Quality organization to support business progress, formulating, communicating and implementing QA strategy that supports manufacturing of products. Coordinate with the leadership team and stakeholders to ensure aligned priorities and effective communication across sites.

Responsibilities

• Serve as key partner for site leadership, managing business integration and site strategy to support manufacturing of product through testing and quality programs to ensure product safety and quality
• Serve as the US Authorized Person, responsible for ensuring compliance with all regulatory requirements and maintaining high standards of quality assurance
• Participate as a member of the Quality Leadership Team in setting quality goals, objectives and policies, ensuring alignment with site goals
• Meet or exceed business, regulatory and customer requirements in accordance with Novo Nordisk Way
• Provide expertise on pharmacovigilance, manufacturing, distribution and clinical practice compliance issues and actions
• Ensure technical training and development on Quality Management across the business
• Direct, coach and manage the quality management team, including training and development, performance management, talent recruitment, employee relations, and driving continuous process improvement and projects
• Maintain effective communication, collaboration and alignment across stakeholders, site management and global sites; coordinate internal audits and external inspections
• Follow all safety and environmental requirements in the performance of duties
• Other accountabilities as assigned

Qualifications

• Bachelor‚Äôs degree in science, engineering, business, or relevant field; minimum of 12 years of experience in pharmaceutical quality, API manufacturing or related area
• Minimum of 5 years managing other managers
• Excellent working knowledge of GMP regulations relevant to the business
• Proven mentoring and development capabilities
• Excellent written and verbal communication skills
• Strong presentation skills
• Proven experience in mentoring/development, process confirmation, change management, planning and execution
• Demonstrated ability to review complex organizational plans and provide guidance for success
• Proven process improvement and problem-solving skills
• Master‚Äôs degree in science, engineering or business preferred
• Knowledge of systems within pharmaceutical industries including oral drug production preferred