Novo Nordisk is looking to solve the problem of ensuring product safety and quality in the manufacturing of clinical products through robust quality assurance programs and compliance with regulatory requirements.
Requirements
- Excellent working knowledge of GMP regulations relevant to the business required
- Knowledgeable in systems within pharmaceutical industries to include parenteral drug production and/or Active Pharmaceutical Ingredient (API) preferred
- Proven expertise in mentoring/development required
- Proven expertise in mentoring/development, process confirmation, change management, planning/organizing & managing execution required
- Demonstrated ability to review complex organizational plans & provide any required or necessary guidance to ensure success required
- Proven process improvement & problem-solving skills required
Responsibilities
- Oversee the CMC QA Organization for the site, which includes responsibility for the Quality Assurance (QA) function and serves as the leading expert in quality, compliance, and quality management systems (QMS).
- Provide direction & coordinate the Quality organization activities to support the business progress.
- Formulate, communicate and implement the QA strategy that supports the manufacturing and testing of clinical products at CMO partners.
- Plan and execute qualification and operational readiness initiatives required to support clinical API internal manufacturing.
- Serve as key partner for site leadership, managing business integration & 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
- Ensure technical training & development on Quality Management is in place across the site
Other
- Ability to travel up to 10% of the time (% can change on a case-by-case basis based on the role).
- Supervisory.
- Excellent written & verbal communication skills required
- Strong presentation skills required
- Bachelor’s degree in science, engineering, business, or relevant field of study from an accredited university required, with a minimum of ten (10) years of experience in pharmaceutical quality, active pharmaceutical ingredient (API) industry, manufacturing or a related area required
