Beschreibung
QUALITY SYSTEMS MANAGERLocation: Solothurn, Switzerland
Duration: 6 months initially
My client, one of the top 10 biopharma companies, is currently looking for a QUALITY SYSTEMS MANAGER with expert level knowledge of Quality System operations and business processes within a GMP Biotech environment.
As the QUALITY SYSTEMS MANAGER, your responsibilities will include mapping and gap analyses of the quality management system for operational readiness, authoring procedures or policies and facilitating site management reviews and maintaining the Site Master File to eventually ensure full GMP compliance and readiness for regulatory inspections.
This role is expected to be cross-functional between the Solothurn Quality and site organization and all parts of the quality line organization (Quality Operations, Quality Control, Quality Engineering, Corporate Quality) as well as for relevant partner departments and sites.
Responsibilities:
- Drive activities to support the readiness of the QMS and supporting business processes for the start-up of GMP production in Solothurn.
- Support GMP operations as well as ongoing expansion projects in a paperless environment
- Responsible to drive continuous improvement activities in the area of quality
- Serve as site liaison to global functions for documentation, training, and corporate quality systems e.g., change control, CAPA, quality risk management, data integrity and exception management.
- Support site governance teams such as Management Review, Quality Exceptions review board, Change Control Review board, QMS implementation, Inspection Readiness and Inspection Management
- Support the site in providing quality key performance indicators
- Build partnership with the global quality organization and corresponding partner site in US to ensure local implementation of the global QMS.
- Manage the Quality Risk Review Process at the Solothurn site
- Lead selected activities to ensure the local implementation of global quality systems at the Solothurn Site through current state of construction through commissioning, validation, regulatory approval and into daily GMP operations.
Qualifications:
- Bachelor's Degree or master's degree in Life Science preferred
- Approximately 10 plus years of experience in pharmaceutical or biotech manufacturing environment. Prior experience with fully electronic operations and management is preferred.
- Fluency in English is required
- Prior experience with facility construction and start-up strongly preferred.
- Must have proficiencies with the Quality systems and business processes associated
- Demonstrated ability to work autonomously and to lead project teams in a matrix organization. Project Management experience is required.
- Strong oral and written communication skills and ability to communicate with all levels of management, peers, contractors, and external partners effectively.
- Strong presentation and organizational skills
- Demonstrated problem solving skills.
- Must have strong technical skills and be proficient with typical productivity software (Word, Excel, PowerPoint, Visio, etc.)
- Candidates with experience in drug substance (or API) and drug product are preferred.
- Experience with IT systems such as Track Wise, Oracle PLM, electronic documentation, training and risk management systems is required.
- Experience with LEAN, Six Sigma, and continuous improvements is beneficial
Keywords: QA, Quality Assurance, Biopharma, Manufacturing, CAPA, Process, GMP, QMS, Quality Management System, Project Management, Pharmaceuticals, Biotechnology, Switzerland, Solothurn
Sthree Switzerland is acting as an Employment Business in relation to this vacancy.