For our client, a global company in the pharmaceutical industry, we are looking for a motivated experienced candidate as
Quality Manager - TRD - 3rd Party QA Management (f/m/d)
- Responsible for the evaluation of the compliance status, approval and oversight of Third Parties used in global TRD (e.g. approves Third party Assessments / TA, approves list of Third Parties).
- Manages establishment of Quality Agreements with Third Parties from supporting the negotiations to the final signature in alignment with the TA, audit reports, and applicable Novartis SOPs and standards as well as Health Authority requirements.
- Responsible for the execution of risk assessments and performance tracking of Third Parties to allow continuous monitoring and early detection of negative trends, proposing remediation actions and escalating as required.
- Leads and manages the creation and maintenance of SOPs and related documents and sets standards for global QA Third Party management (e.g. SOPs and QA Agreement templates) as per Novartis standards and Health Authority requirements.
- Leads key initiatives in the global TRD Third Party Management work stream (e.g. Third Party Quality Risk Assessments, improvement projects and establishment of new processes).
- Provides guidance and consultation to TRD Line Units in GMP compliance related issues focused on Third Party management and in areas of expertise (e.g. TSE/BSE, etc.).
- Fluent English required (oral & written).
- Good knowledge of cGMP, working knowledge in technical development, production or QA.
- Sound scientific, technical and regulatory knowledge.
- Broad working experience (approx. 5 years) in technical drug development, production, QC or QA.
- Good organizational and decision-making skills.
Good and proven ability to analyze and evaluate cGMP compliance.
Start date: ASAP
Actual End Date 6 months (Temporary Position)
Place of work: Basel-Stadt
Please apply online. For further information about the position, please contact your Kelly recruiter, Mrs Stefanie Bucheli +41 61 270 80 17. We are looking forward to getting to know you!