Job Purpose (State in one sentence the overall objective of the role)
Manage projects and processes to support departmental projects and objectives according to agreed timelines and standards and assure compliance with GMP is main-tained in TRD.
Major Activities (Describe main activities)
1.Manage portfolio of projects (third parties, analytical instruments and manufacturing equipment as per area of responsibility) 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, gap assessments) and related tools (e.g. IT, document systems, training tools, facility validation) to ensure GMP compliance.
3.Represent TRD QA in initiatives.
4.Lead project related activities (e.g. development of new tools, processes, Quality Initiatives, QM/QDs implementation, Quality Plans, training activities, qualification and facility upgrade activities, IT validation projects).
5.Write, review and approve documents (e.g. procedures, records, SOPs) and re-lated 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) .
9.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 cGMP guidelines, health authority guidances, SOPs, HSE, etc). Promote and enforce compliance to guidelines. If managing as-sociates, 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.
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
Minimum: Basic degree in science or relevant discipline (BSc or equivalent)
Desirable: Advanced degree in science of relevant discipline (MSc or equivalent)
Good knowledge of cGMP, working knowledge in technical development, production or QA.
Sound scientific, technical and regulatory knowledge.
Broad working experience (min. 8 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.
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