Sr. Regional Manager, Quality Assurance

vor 2 Wochen

Baar, Schweiz Biogen Vollzeit

Company Description**
About this Role**:
Reporting to the Head of Global Commercial QA, the Sr. Commercial Manager QA (MENA/MART region) will provide Quality oversight and support for GMP and GCP activities across assigned Biogen affiliates and distribution partners. The RM will oversee the development and implementation of the quality systems whilst involved and participate in product launches and co-ordinate communication between Affiliates, Distributors and other Biogen functions/stakeholders

Job Description**
What You’ll Do**:
Provide operational support and supervision for assigned markets with a Biogen Affiliate
- Provide guidance to ensure compliant QMS
- Attend regular QMR meetings with affiliates
- Support license implementation and maintenance, ensuring cross-functional input as well as supporting inspection/audit readiness, co-ordination and follow up actions.
- Monitor market activities to minimize out of the stock situations.
- Approve exceptional in-country activities as required (e.g repackaging)

Provide QA oversight for Managed Access Programs
- Oversee and ensure that all associated documentation/activities required are available and compliant.
- Approve associated internal documents and requirements to enable implementation on time

Provide QA strategic and operational support and oversight in markets with a Distribution Partner.
- Communicate Biogen quality requirements and coordinate and manage the assignment and approval of quality contracts.
- Collaborate with quality counterparts at Distributors to maintain product quality and integrity in accordance with contractual agreement.
- Act as point of contact for distributor counterpart for any quality topics and communicate any specific requirements to internal stakeholders.

Implementation and oversight of affiliate QMS
- Develop, ensure implementation, and oversee the QMS, ensuring compliance with Biogen’s global QMS as well as local requirements/licences.
- Support and approve the local Quality Manual and associated revision
- Review and approve changes and updates to Affiliate QMS

Provide QA input and oversight for product launch in assigned regions.
- Establish QUAG’s with external partners
**Who You Are**
You are an experienced QA professional with proven hands-on experience, ideally in the MENA/MART region, with knowledge of local GMP/GDP regulations and previous experience working in an Affiliate(s) environment ready to widen your geographical scope and undertake QA responsibility for those markets. You are a dynamic person, willing to travel and to develop strong relationships with internal/Biogen affiliates and external/Commercial partners.

Qualifications**
Required Skills**:

- Bachelor’s degree
- Minimum 10 years experience in the pharmaceutical industry
- Strong knowledge of GMP regulations, especially local regulations in the assigned regions.
- Experience with different distribution models: wholesaler, third party logistics and distribution partners
- Experience in local Health authorities’ inspections and customer’s audits
- Fluency in English, spoken and written. Knowledge of any local language is an advantage.

Additional Information**
Preferred Skills**:

- Experience in quality oversight of distribution activities outside EEA region, especially MART (Middle East, Africa, Russia and Turkey) is an advantage
- Previous experience in logistics/distribution areas especially in non-EEA markets is an advantage; experience in MART regions constitute a preference.
- Knowledge of other EU languages is an asset.
- Previous experience with implementation of Serialization in market and/or track and trace systems is an asset

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