(Senior) Quality Manager - TRD NCE QA

Summary

Role Purpose: Manage independently technical development projects and related processes to support departmental portfolio, projects and objectives according to agreed timelines and standards within Technical Research & Development (TRD).

About the Role

Major accountabilities

• Manage project related activities e.g. TRD product portfolio, processes, quality initiatives, Quality risk Assessment) as per area of responsibility
• Support Project management functions as a project team member
• Provide Quality Oversight and support to TRD line functions in GMP related topics as per area of responsibility
• Comply with internal and external guidelines regarding quality and safety (Quality Manual, regulatory cGMP guidelines, Health Authority guidance, SOPs etc.)
• Release of batches, materials and components for clinical trials with issuance of batch certificates, and approval of development documentation
• Review of master and executed batch record
• Write, review and complete GMP relevant documents (e.g. CoAs, BRR, checklists, risk assessments)
• Support audits and inspections
• Can act as QA SPOC for assigned CMOs

Key performance indicators

• In accordance with departmental objectives such as support of projects with agreed quality and delivery dates, passing of internal and external inspections
• Maintain sound working relationship with internal customers and external partners
• Meet quality and timelines in area of responsibility
• Feedback from team members
• Act in accordance with Novartis standards in particular: cGMP, ethical, health safety and environment (HSE), and information security (ISEC)

Minimum Requirements

Work Experience:

• Masters
• Bachelor/Technician (>5 years pharma)
• Critical Negotiations.
• Project Management.
• Collaborating across boundaries.

Skills

• Oligo manufacturing and analytics highly desired
• Sterile manufacturing highly desired
• Good knowledge of cGMP, working knowledge in technical development, production or QA
• Good organizational and decision-making skills
• Good and proven ability to analyze and evaluate cGMP compliance
• Agility
• Continuous Learning
• Influencing Skills.

Languages

• Fluent English required (oral & written)
• Good skills in site (German) desired (oral)

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