(Senior) Quality Manager TRD NCE QA

Basel - Switzerland

Monthly Salary: Not Disclosed

Posted on: 16 hours ago

Vacancies: 1 Vacancy

Job Summary

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

Required Experience:

Manager

Job Description SummaryLocation: Basel Switzerland #onsiteRole 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 Des...