(Senior) Quality Manager TRD NCE QA

Job Description Summary

Location: Basel Switzerland #onsite

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).

Job Description

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)

Skills Desired