Sr. Associate I, Quality Technical Services

vor 3 Wochen

Luterbach, Schweiz Biogen Vollzeit

**Job Description** About This Role**

The main responsibility of the Sr. Associate I, Quality Technical Services & Compliance (QTS) is to 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. The Sr. Associate I will also serve as quality point of contact for Inspection readiness and management as well as Coordination of the Reulatory filing requests for the Solothurn site. In addition he will act as project managers for other line functions and ensure quality commitments are delivered on time.

The Sr. Associate I will work within the team to help manage site governance teams such as Inspection readiness, regulatory filing, Management Review, Quality Exceptions review board, Change Control Review board, QMS implementation, Inspection Readiness and Inspection Management. Project Management experience is required.

In addition, this role is expecting to support on compliance related to facility, equipment qualification, cleaning validation, such as protocol review to ensure the safety, efficacy and purity of the products manufactured by Biogen.

The Sr. Associate I will ensure and lead selected activities to ensure the local implementation of Biogen global quality systems at the Solothurn Site through current state of construction through commissioning, validation, regulatory approval and into daily GMP operations. This will follow a quality plan both covering current GMP operations and future extensions projects. An inherent part of the Quality Plan is management of the Quality Risk Register and ensuring identified risk assessments will be authored and in place at right time, expert knowledge in quality risk management like ICH Q9 is required.

As a consequence of the above job activities will among other things 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 (Corporate Quality, Inspection readiness, Quality Operations and Engineering, Quality Control) as well as for relevant partner departments and sites.

As such, the position is expected to have expert level knowledge of Quality System operations and business processes within a GMP Biotech environment. Previous experience with IT systems such as Trackwise, Oracle PLM, electronic documentation, training and risk management systems is required. It will also be beneficial to have experience with LEAN, Six Sigma and continuous improvements.

**What You'll Do**
- Drive timeline activities to support the readiness of the QMS and supporting business processes for the start-up of GMP production as well as subsequent routine operations in Solothurn.
- Represent Solothurn Quality within the global quality organization to ensure local implementation and maintenance of the global QMS, e.g. for Training, Exceptions, CAPA and Management Review processes and other topics as required and to provide feedback from the site SOL to the global quality organization
- Coordinate regulatory filing activities and support on inspection readiness ensuring compliance and quality oversight on facility, site project, equipment qualification, cleaning validation through protocol / report management other tasks related to Quality Risk process for the site and corresponding risk assessments.

**Qualifications** Who You Are**

You have relevant experience from a similar role in pharmaceutical or biotech manufacturing. Proficiency in Quality systems and automation integration, along with strong project management skills. You have experience in Inspection management, regulatory filing, and excellent communication abilities, with experience in drug substance and drug product manufacturing.

**Required Skills**:

- Bachelor's Degree as a minimum, Master degree in Life Science preferred.
- 7 years of experience in pharmaceutical or biotech manufacturing environment or equivalent experience. Prior experience with fully electronic operations and management is preferred.
- Must be highly proficient with the Quality systems (deviation, change control, risk management, CAPA, data integrity, management review) and business processes associated with automation and integration of testing and production systems
- Strong experience in Inspection management and required knowledge in regulatory filing
- English proficiency is mandatory dual language is preferred ( German ).
- Prior experience in project management as Quality oversight
- Demonstrated ability to work autonomously and to lead project teams in a matrix organization.
- Strong oral and written communication skills and ability to

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