Senior Quality Manager TRD NCE QA

Job Description Summary

Location:

Basel Switzerland #onsite

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).

• 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

• 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

Act in accordance with Novartis standards in particular : cGMP ethical health safety and environment (HSE) and information security (ISEC)

• Masters
• Bachelor / Technician (>
• 5 years pharma)

• 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.

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

• Manager

Continuous Integration,Quality Assurance,FDA Regulations,Root cause Analysis,TFS,Food Processing,ICH Q10,Jira,Software Testing,Quality Management,Selenium,Github

Full‑Time

years

1