(Senior) Quality Manager - TRD NCE QA at Novartis

, Basel-City, Switzerland -

Full Time

Start Date

Immediate

Expiry Date

01 Mar, 26

Salary

0.0

Posted On

01 Dec, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Project Management, Quality Oversight, cGMP Compliance, Oligo Manufacturing, Sterile Manufacturing, Analytical Skills, Organizational Skills, Decision-Making Skills, Agility, Continuous Learning, Influencing Skills

Industry

Pharmaceutical Manufacturing

Description

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 Improving the lives of people living with disease takes more than innovative science. It takes a focus on the needs of people and a community committed to meeting them. It takes a team of people like you. Working together. Learning together. Thriving together. Discover how you can join us in changing people’s lives. In the context of China Cross-Border Data Transfer (CBDT) policy, if you need to apply for a position in China, please go to the local Recruiting System TaleNov .

Responsibilities

Manage technical development projects and related processes to support departmental objectives. Ensure compliance with quality and safety guidelines while providing oversight and support to TRD line functions.