Senior Manager -Quality Assurance USO

Role Summary

Senior Manager - Quality Assurance USO. Developing Quality and US Operations (USO) strategic objectives and strong business understanding of the value chain and customer focus. This role enables and ensures compliance against health authority regulations and Novo Nordisk requirements in relation to the Pharmacovigilance (PV) process at NNI. This role fulfills the Quality Assurance function in processes including, but not limited to, Deviation Handling, Content Control, and Change Control. Additionally, this role provides SME-level input from the affiliate perspective when required. This role also provides direct support for continuous improvement initiatives, locally or globally driven, for the covered processes.

Responsibilities

• Deviation Management: Acts in role of Quality Assurance for NN Deviation process within the PV domain, including review and disposition of submitted deviations in the Vault Quality system.
• Deviation Management: Supports development of comprehensive, relevant resources (e.g. training program, FAQs) to enable local compliance to Deviation process requirements.
• Deviation Management: Execute regular surveillance, follow-up, and reporting program to ensure local process compliance.
• Deviation Management: Acts in role as process SME for the Deviation process at USO. Support internal and external stakeholders with issue resolutions in a timely fashion and in a manner which meets their expectations.
• Change Control: Supports the affiliate (i.e. Regional) Center of Excellence (COE) for the Change Control process with specific focus in the PV domain.
• Change Control: Acts in the role of Quality Assurance for NN Change Control process, including review and disposition of submitted change requests in the Vault Quality system.
• Change Control: Execute regular surveillance, follow-up and reporting to ensure local process compliance.
• Change Control: Acts in role of process SME for the Change Control process at USO. Support internal and external stakeholders with issue resolutions in a timely fashion and in a manner which meets their expectations.
• Content Control: Acts in role of Quality Assurance for NN Content Control process, including review and disposition of submitted standard operating procedures (SOPs) or other similar documents within the QualityDocs system.
• Content Control: Develops and executes regular surveillance, follow-up, and reporting program to ensure process compliance.
• Content Control: Supports development of comprehensive, relevant resources (e.g. training program, FAQs) to enable local compliance to Content Control process requirements within the PV domain.
• Content Control: Acts in role as process SME for the Content Control process across USO. Support internal and external stakeholders with issue resolutions in a timely fashion and in a manner which meets their expectations.
• Quality Assurance: Provides secondary support to all USO Quality Management processes, including but not limited to Product Disposition and/or Audits and Inspections, as necessary.

Education / Qualifications

• Bachelor‚Äôs degree required; relevant experience may substitute for degree, when appropriate; advanced degree preferred
• Requires a minimum of 9 years of progressively responsible related experience, with at least 4 years working within or directly collaborating across the PV domain; pharma experience preferred
• Excellent interpersonal skills and ability to interact with staff across all levels. Demonstrated ability to work independently without appreciable direction. Capability to identify, evaluate, and resolve complex issues that require reviewing multiple factors to determine proper resolution, with management support as needed. Demonstrated problem solving skills, creativity, and initiative

Skills

• Interpersonal skills; ability to interact with staff across all levels
• Independent work style with minimal direction
• Problem solving, analytical thinking, and initiative

Education

• Bachelor‚Äôs degree required; advanced degree preferred

Additional Requirements

• 0-10% overnight travel required