Quality Senior Project Manager

For our client in Basel we are looking for a Quality Senior Project Manager for a 4 months contract.

Place: Basel
Period: 1.1.2017-30.04.2017
Workload: 100%

Major 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 (eg procedures, records, third party work, contractors, clinical trial material, components, gap assessments) and related tools (eg IT, document systems, training tools, facility validation) to ensure GMP compliance.
3. Represent TRD QA in initiatives..
4. Lead project related activities (eg development of new tools, processes, Quality Initiatives, QM/QDs implementation, Quality Plans, SQRA, training activities, qualification and facility upgrade activities, IT validation projects).
5. Write, review and approve documents (eg procedures, records, SOPs) and related tools (eg 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 (eg 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 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 values and behavior including objectives setting, performance evaluations, development planning and participate in recruiting process.

Education
Minimum: Basic degree in science or relevant discipline (BSc or equivalent)
Desirable: Advanced degree in science of relevant discipline (MSc or equivalent)

Languages:
Fluent English required (oral & written). Good skills in site (local) language desired (oral).

Experience/Professional requirement:
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 (eg several years of experience as head of laboratory).
Good organizational skills.
Good and proven ability to analyze and evaluate GMP compliance.

For more information, please contact:
Anna Chmura
(see below)