Director - Product Quality

Role Summary

Director - Product Quality oversees the CMC QA Organization for the site, providing direction and coordination of the Quality function to support manufacturing and testing of clinical products at CMO partners. Formulates and implements the QA strategy, plans qualification and operational readiness for internal API manufacturing, and ensures strong communication with leadership and stakeholders to align priorities.

Responsibilities

• Serve as a key partner for site leadership, managing business integration and site strategy to support manufacturing of clinical product through testing and quality programs to ensure product safety and quality
• Responsible for ensuring compliance with all regulatory requirements and maintaining the highest standards of quality assurance within the organization
• Participate as a member of the Quality Leadership Team in setting quality goals, objectives, and policies, ensuring alignment with the site’s goals
• Meet or exceed business, regulatory, and internal customer requirements in accordance with Novo Nordisk Way
• Provide expertise on Good Manufacturing Practice compliance
• Ensure technical training and development on Quality Management is in place across the site
• Direct, coach and manage the site quality management team, including training and development, performance management, talent recruitment, employee relations, and driving continuous process improvement
• Maintain effective communication, collaboration, and alignment across stakeholders, site management, and global partners
• Coordinate and oversee internal audits and external inspections of CMOs
• Follow all safety and environmental requirements in the performance of duties
• Other accountabilities as assigned

Qualifications

• Bachelor’s degree in science, engineering, business, or relevant field from an accredited university; minimum of ten (10) years of experience in pharmaceutical quality, API industry, manufacturing, or related area
• Master’s degree in science, engineering, or business preferred
• Minimum of five (5) years managing other managers
• Excellent working knowledge of GMP regulations relevant to the business
• Knowledgeable in systems within pharmaceutical industries including parenteral drug production and/or API preferred
• Proven expertise in mentoring/development
• Excellent written and verbal communication skills
• Strong presentation skills
• Proven expertise in mentoring/development, process confirmation, change management, planning/organizing and managing execution
• Ability to review complex organizational plans and provide guidance to ensure success
• Proven process improvement and problem-solving skills