(Senior) Quality Manager - TRD NCE QA

Major accountabilities:

• Manage project related activities 8e.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)

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network(link is external)

Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards