Job Detail

Job Description

• Drive timeline activities to support the readiness of the QMS and supporting business processes for the start-up of GMP production in Solothurn.


• Design, review and maintain Site Master File for the Solothurn site to ensure site GMP readiness as per project timeline.


• Represent Solothurn Quality within the global quality organization to ensure local implementation of the global QMS


• Responsible for managing the Quality Risk Register and ensure appropriate risk assessments are in place


• Ensure site training plan and system for content/documentation are in place and maintained.

Qualifications

• Bachelor’s Degree or Master 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.


• This position will require frequent international travel during the first two years of employment (up to 30% at times), periodically thereafter.


• Dual Language preferred with a preferences for  English  and German .


• Prior experience with facility construction and start-up strongly preferred.


• Must have proficiencies with the Quality systems and business processes associated with automation and integration of testing and production systems. 


• Demonstrated ability to work autonomously and to lead project teams in a matrix organization.


• 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.

Additional Information

The main responsibility of the Sr. Associate III, Quality Systems and Compliance 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 III will also serve as quality point of contact for project managers for other line functions and ensure quality commitments are delivered on time.

The Sr. Associate III will help manage the Quality Risk Review Process  at the Solothurn site, work within the team to help manage site governance teams such as Management Review, Quality Exceptions review board, Change Control Review board, QMS implementation, Inspection Readiness and Inspection Management. Project Management experience is required.

The Sr. Associate III 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 (e.g. BMC2). 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 (Quality Operations, Quality Control, Quality Engineering, Corporate Quality) 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.