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Job ID 221939BR Position Title Technical Research and Development Senior Quality Project Manager Division Global Drug Development Business Unit QA GDD Country Switzerland Work Location Basel Company/Legal Entity Novartis Pharma AG Functional Area Quality Job Type Full Time Employment Type Regular Job Description Manage projects and processes to support departmental projects and objectives according to agreed timelines and standards and assure compliance with Good Manufacturing Practice (GMP) is maintained in Technical Research and Development (TRD). In addition to QPM as Senior QPM roll exist as well: senior level with > 8 years of corresponding experience, can act as deputy for a QPL.
1. Manage portfolio of projects, support a discipline and/or provide a service on his/her own or with a team of associates. May provide functional expertise in area of responsibility.
2. Review and approve deliverables (e.g. procedures, records, third party work, contractors, clinical trial material, components) and related tools (e.g. IT, document systems, training tools, facility validation) to ensure GMP compliance.
3.Represent TRD Quality Assurance (QA) in initiatives..
4.Lead project related activities (e.g. development of new tools, processes).
5. Write, review and approve documents (e.g. procedures, records, Standard Operating Procedures (SOPs) and related tools (e.g. IT, document systems, training tools, facility validation) to ensure GMP compliance
6.Perform inspections and audits as required
7.Contribute to the evaluation of new QA tools.
8.Provide support to TRD line functions in GMP compliance related issues in area of expertise (e.g. medical device standards) .
9Coach and develop people; participate in recruitment of talent. Support a culture of high performance and trust. Assure that the required level of knowledge and skills is available and identify competency gaps. Establish and implement training and development plans.
10.Meet internal and external guidelines regarding quality and safety (quality manuals, regulatory current Good Manufacturing Practice (cGMP) guidelines, health authority guidance, SOPs, Health, Safety & Environment (HSE), etc). Promote and enforce compliance to guidelines. If managing associates, ensure same for them.
11.Support project management functions as a sub-team member or in preparation for a PAI.
12.Write/contribute to internal compliance policy and/or comment to regulations.
13. Guide team members in line with Novartis values and behavior including objectives setting, performance evaluations, development planning and participate in recruiting process.
Minimum requirements Minimum: Basic degree in science or relevant discipline (BSc or equivalent)
Desirable: Advanced degree in science of relevant discipline (MSc or equivalent) Fluent English required (oral & written).
Good skills in site (local) language desired (oral).
Good knowledge of cGMP, working knowledge in technical development, production or QA.
Sound scientific, technical and regulatory knowledge.
Broad working experience (min. 5 years) in TRD, production or QA (e.g. several years of experience as head of laboratory).
Good organizational skills.
Good and proven ability to analyze and evaluate GMP compliance.