JOB PURPOSE:

The main responsibility of the Head of QMS & Compliance is to lead the effort to ensure the Solothurn site is in a state of compliance and lead the local implementation and governance of Biogen Global Quality Systems. This function has the overall responsibility to ensure the requirements of the Quality Systems Regulations is effectively established, maintained and improved.
This will include, but is not limited to:

1.  Drive the maintenance and continuous improvement of the Site Master File,  the Site Quality Plan, Site Quality Risk Management and Data Integrity Forum and trend reports.
2.  Managing and improve the Site Management Review Process and participate in Global QMRs as needed. 
3. Guide expert SMEs  to maintain and improve the site inspection readiness and Inspection Management processes at the Solothurn Site partnering with the global organization
4. Being the point of contact for Corporate Quality functions of the key Quality Systems (internal and external auditing, regulatory intelligence, documentation control, change control, training, exception and CAPA management and ensure these are robustly implemented at the Solothurn site
5. Ensure customized Quality Governance is consistently provided to all functional leads in Solothurn. 
6. Responsible to co-ordinate the contributions of the Solothurn site to APRs/PQRs.
7. Lead generation of inspection responses across the site and the global Biogen Organization. 
8. Ensure that Site content to regulatory filings are provided on time according to submission plans. 
9. Be single point of quality contact for partners to ensure full compliance to quality agreement commitments
10. Establish appropriate quality communication to partners in collaboration with Quality 
11. Be single point of contact for Quaity Sub-tem of asset teams of Solothurn site core products 
12. Ensure that quality systems applied at site accommodate routine manufacturing operations as well as CAPEX projects. 

MAIN ACCOUNTABILITIES:

1. Designs and manages (including their development) the Solothurn Compliance team experts who themselves are responsible for specific functions according to job descriptions 
2. Maintain and continuously improve all aspects of the  QMS at the Solothurn site as described in job summary 1)-9)
3. Ensure adherence of Solothurn site quality deliverables to partners according to relevant quality agreements and act as single point of contact for Quality sub teams.
4. Represent Solothurn Quality within the global quality organization to ensure local implementation of and proactive input to the global QMS
5. Ensure that Inspection Readiness & Inspection Management at Solothurn are maintained in a state of readiness. 
6. Maintain and improve established Quality Governance Processes including but not limited to: a) provide regular updates to SLT on quality metrics, b) drive exception meetings and forums, c) provide input to weekly management reporting on quality system activities. 

EDUCATION:

• Master degree in Life Science/ or Technical Discipline

REQUIRED SKILLS:

• At least 5-10 years of experience within the pharmaceutical Industry or biotech manufacturing environment, prior experience with fully electronic operations and management is preferred.

• The incumbent of this position is required to have extensive quality system experience, preferably within DS manufacturing of biologics. It is important to apply all principals and experience from excellent quality system knowledge in both the recipe driven batch operations,  quality management and governance and inspection readiness.