Senior Director, Quality
Biogen
Luterbach, Canton of Solothurn, Switzerland
vor 18 Std.
Job Description

The Sr Director of Quality has the overall responsibility for Global Quality Assurance operations at the New Generation Manufacturing (NGM)site. Additionally, the Sr Director role has the heavily strategic component, being responsible for the relationships with the senior management of key internal and external partner per training to site operations. This function has the responsibility to ensure the requirements of all Quality System Regulations are effectively established and maintained to provide PO&T with scalable Quality activities within all business areas. He/she is accountable for the establishment and maintenance of recipe driven operations introduction at the site and modernization of and adherence to Quality systems supporting manufacturing

The main responsibility of the Quality Sr. Director is to build and hire to local quality organization and be part of the local site leadership team and equally serve as a member of the International Quality Organization.

Addtionally this role has the responsibility for the local implementation of the global Biogen quality systems at the Solothurn Site through current state of construction through commissioning, validation, application for manufacturing license, regulatory approval and into daily GMP operations. This function has the overall responsibility to ensure the requirements of the Quality System Regulations is effectively established and maintained and is to ensure a Responsible Person for the Solothurn Site is appointed when necessary.

The new facility and the production process in Solothurn will rely on highly integrated business execution systems, such as Delta V (production automation), Syncade (batch records), Infor10 (enterprise asset management, i.e. maintenance and calibration), KNEAT (validation documentation), Labware LIMS (test data) and Oracle (ERP) and Advanced Process Control (APC). An key responsibility of the Sr. Director of Quality is to ensure that the modified operating paradigm comprised of above components are implemented compliantly and considering needs of other DS manufacturing sites.

 

The holder of this position will be responsible for ensuring that the site is GMP ready as per project schedule. This will include, but is not limited to: batch release, maintaining Site Master File, Quality point of contact for technology transfer, responsible for site management review, host of audits and inspections, effective liaison to the corporate quality functions (internal and external auditing, regulatory intelligence, documentation control, training, exception and CAPA management)

 

Main accountabilities

1. Designs and Manages the Solothurn Quality Organization of leaders and subject matter experts who themselves are responsible for specific functions according to job descriptions.

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

2.  Design, review and maintain elements of the integrated schedule and  quality plan for the Solothurn site to ensure site GMP readiness as per project timeline.

4. Lead Solothurn Quality within the global quality organization to ensure local implementation of the global QMS and lead quality system changes as required by next generation manufacturing operations.

5. Fulfill the leadership responsibility of Sr. director role at the Solothurn site and in the International Quality Organization.


Qualifications

  • University BS degree, preferable MSc. Ph. D in a field of Science
  • Approximately 15 plus years of experience in pharmaceutical or biotech manufacturing environment. Prior experience with site operations preferred. Biologics Mfg Quality and/or Technical Leadership
  • Prior experience with facility construction 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.

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



Additional Information

The main responsibility of the Quality Sr. Director is to build and hire to local quality organization and be part of the local site leadership team and equally serve as a member of the International Quality Organization.

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