1. Quality Operation oversight
- Designs and manages (including their development) the Solothurn Operation Quality Team of subject matter experts who themselves are responsible for specific functions according to job descriptions
2. Qualified Person
- Manages and develops the EU Qualified Person team so that team members are empowered, motivated and have development plans.
- Responsible for the timely release of clinical and commercial products for all International Biogen products to ensure on-time supply of products and adherence to financial targets.
- Prepare and host Health Authority inspection and internal audit at the EU Qualified Person site
3. Site quality
- Manages QMS for oversight of GxP activities with a focus on GMP manufacturing and GDP for commercial and clinical products.
- Ensures manufacture and distribution of Biogen products is performed in a safe, compliant manner, meeting the requirements
And other job duties that may be assigned from time to time.
- Can include cross-function collaborative and project team leadership assignments consistent with personal strategic, operational, and technical leadership
- Master’s degree in Life Science or Technical discipline
- 10+ years of experience in pharmaceutical or biotech manufacturing environment. Prior experience with fully electronic operations and management is preferred.
- Dual Language preferred with a preference for German and English.
- Prior experience with facility construction and start-up strongly preferred.
- Must have proficiencies with the Quality systems and, preferably, with business processes associated with automation and integration of testing and production systems.
- The incumbent must master EU Annex 16 regulation in regards to “Certification by a Qualified Person and batch release” and must comply with requirements in articles 5, 10 and 14 of the Swiss Ordinance on establishment licenses (812.212.1).
- Strong knowledge in biological and solid forms products development and GMP Manufacturing processes
- 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.
- Demonstrated problem solving skills
- Proven experience in managing teams up to 12 Direct and Indirect Reports.
The main responsibility of the Head of Operational Quality is to organize and take the full Quality Assurance responsibility for operational activities on all manufacturing and warehouse processes and related areas. This position is responsible to drive a continuous Quality and Compliance improvement mind-set within the Operations environment to ensure compliance with cGMP’s and Biogen Quality Management System. The responsibilities for the role are to design, own, manage and execute the Batch Release process (specifically for Solothurn site, the main responsibility will be to design a Batch Release process that is applicable).
The job holder is the point of contact for other Quality functions within the Biogen network regarding the release and distribution of manufactured drug substances but not limited to the management of Regulatory Inspections at the Solothurn site.
The incumbent is responsible for communicating any quality issues to senior management. He/she participates to cross-functional teams and interacts with key internal partners such as Planning, Logistics, Manufacturing, Manufacturing Science, Quality Control, Drug and Safety Management. She/he also manages the batch release in charge of the technical release of active substances manufactured by the manufacturing site of Luterbach in Switzerland.
The holder of this positions acts as Responsible Technique / fachtechnisch veranwortliche Person (i.e. Qualified Person) for Switzerland for Biogen International GmbH. As such, Qualified Person, she/he is authorized to give directives (also towards management) in her/his area of responsibility.
He/she reports to the Site Quality Lead of Biogen Solothurn site.
The job holder will act as Quality Director in Trackwise system exclusively for Planned exception.