Shire Qualified Person in Amsterdam, Netherlands

The individual will operate from an Amsterdam based Contract Manufacturing Organization.

This individual will work for the Belgium Quality Operations sub-group of ViroPharma sprl, part of the Shire group of companies. This unit oversees commercial and clinical activities, contract manufacturing operations, supply chain operations and supplier quality functions performed on behalf of Shire.

This individual will maintain strong operational insights and is able to influence complex organizations serving as Shire’s key point of contact onsite to support resolution of issues with potential product impact.

This individual will have primary responsibility for batch disposition activities of commercial Cinryze. The QP is the person responsible for all batch certification and associated responsibilities as detailed in 2001/83/EC as amended.

This individual is responsible for ensuring consistency and communication within Shire Quality and with key stakeholders. This leader will partner closely with other Technical Operation leaders especially External US QA Operations, Internal QA Operations, QC, Validation, Compliance, Regulatory and Supply Chain to ensure timely disposition of product.

This individual will be responsible for the successful, timely completion of goals and objectives, which will strengthen the Shire EU Quality organization. This position will have no direct reports involved in the on-site CMO batch review and Release Process.

This position is responsible for the Quality oversight of contact manufacturers, testing and for leading, monitoring and supporting the quality performance of European quality systems according GMP & GDP standards.

The QP is responsible for ensuring that medicinal products have been manufactured and tested in accordance with GMP and the Marketing Authorization/IMPD

The individual may be responsible for, but is not limited to:

  • Primary contact for IGZ regarding recall, inspection and MIA

  • Submitting license changes to the IGZ

  • License maintenance (WDL & MIA)

  • Maintenance of the batch register

  • Performing batch disposition

  • SOP Approval

  • Approve or reject CMO’s, distributors and contact laboratories

  • Oversight of CMO’s, distributors and contact laboratories

  • Leading investigations

  • Reviewing and approving batch records, specifications, deviations and change controls

  • Designing, implementing and improving EU Quality metrics and quality systems

  • Leading meetings and audits

  • Leading and facilitating technology transfer, process scale-up, and process improvement projects.

  • Leading drug product complaint investigations

  • Approving Product Quality Reviews.

  • Implementation and maintenance of Technical Quality Agreements as required

  • Assisting in meetings with external parties and representing Shire in a professional manner.

  • Managing QA professionals - Responsible for timely hiring, training and development of qualified staff to ensure effective execution of roles and responsibilities, compliance and attainment of operational and development goals.

  • Fostering the growth and development of staff

  • Anticipating and filling capability gaps that may arise as new technologies are acquired

  • Proactively identifies and drives remediation of risks within sphere of influence

  • Provides information to evaluate and coordinates local Management Reviews

Authorities

  • Authorized to release or reject batches of commercial and clinical product

  • The QP should ensure that the appropriate resources to ensure systems and communications are in place and in operation

  • Access to senior management

  • Eligible to fulfill the role of RP as per EU GDP requirements.

  • Access to any documentation required to fulfill responsibilities

  • Approve or reject CMO, distributors and contract test laboratories as required

  • Kept informed of changes in the organization that could affect the MA by senior management

  • Kept informed of the internal and external audit schedule and reports covered in the MIA

  • Approve Technical Quality Agreements

  • Coordinate and attend authority inspections of Shire operations in EU

  • Ensure that there are appropriate QP/RP/QA resources to ensure systems and communications are in place and in operation

In partnership with other members of the organization

  • Ensure coordinated product release prioritization, investigation planning and timely investigation and release of batches

  • Provide support to External QA Operations area in terms of routine operations

Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.

Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.