Careers that Change Lives
As Head of BioPharma you will own be the General manager of Medtronic BioPharma; maintaining a management structure, ensuring compliance of BioPharma with all applicable regulations for maintenance of market authorization, manufacturing, distribution, and wholesaler licenses.
The role reports to CST CMRA & HEPR Medical Science Leader.

You will Act as Head of Quality and Regulatory departments to:

• Develop, maintain, and improve the Quality Management system of Medtronic BioPharma.
• Develop, maintain, and implement Regulatory strategies for new medicinal product development, or acquisitions, in line with company strategy.

You will supervise pharmaceutical production and ensure continuity of supply.

As part of your role, you will:

• Provide organizational leadership, as well as drive talent acquisition and development. 
• Ensuring compliance of BioPharma with all applicable license holder responsibilities (EU Dir 2001/83/EC as amended, and Eudralex Vol.4 including annexes), and compliance of pharma sales organization with all applicable regulations.
• Ensuring compliance of BioPharma with all applicable regulations for maintenance of market authorization, manufacturing, distribution, and wholesaler licenses. 
• Ensure that an appropriate pharma Quality System is implemented and monitored for its effectiveness.
• Establish, drive, and execute BioPharma strategies to support the Pharma business for Medtronic. 
• Implement and lead change management initiatives to ensure smooth transitions and adaptation to new regulatory requirements, market changes, and organizational developments.
• Manage BioPharma as a shared service cost center and integrate the cost center in the overall Cranial & Spinal Technologies’ P&L, including financial agreements with other OUs and/or geographies outside of Europe. 

Leading Quality Assurance for ensuring that:

• BioPharma Quality System is developed, implemented, maintained, enforced, and improved in line with international (e.g. EU and Swiss) pharmaceutical regulations, standards and management guidelines, as well as with Medtronic Corporate Policies, in coordination with all involved country entities.
• The supervision of all pharmaceutical operations of the company, including (contract-) manufacture, receipt, release, storage and distribution of the pharmaceuticals.
• Ensuring batch records for components, drug substances and finished products are prepared and reviewed prior to Qualified Persons batch release.
  The Quality department works closely together with the Quality and project groups in all concerned Operating Units to establish and maintain alignment with Corporate and Business Unit Quality Management Systems.
• An appropriate documentation system is deployed and implemented including the archiving.
• An appropriate training system is in place for the training of BioPharma employees including sales representatives.
• Systems are maintained in a validated status.
• An appropriate CAPA process, using appropriate problem-solving tools, is deployed and implemented.
• An appropriate quality risk management system is maintained, reviews and approves risk management plans for product and processes.
• Change requests are reviewed, assessed, and implemented as defined in the action plan.
• Internal and external Quality Management System audits are conducted.
• Supplier monitoring is in place and efficient.
• Internal audits are performed annually.
• Complaints are registered and handled appropriately in a timely manner.

Leading Regulatory Affairs:

• Develop and implement regulatory strategies for new medicinal product development, or acquisitions, in line with company strategy.
• Interface and negotiate with EU Competent Authorities on regulatory issues. 
• Provide input regarding Medicinal Product Regulatory requirements to obtain timely regulatory approvals as part of the development planning.
• Organize and lead regulatory submissions to obtain and maintain Marketing Authorization (MA):
  o    Establish submission timelines and manage the timely receipt of information required to meeting submission target dates.
  o    Review and determine the applicability, accuracy, and completeness of documentations for inclusion in regulatory submissions. 
  o    Organize and lead the submission and approval for MA in national, mutual recognition, decentralized and centralized procedures. 
• Coordinate and support CTAs, IMPDs.
• Handle of urgent safety restrictions and submissions of safety variations.
• Handle of requests for information from Competent Authorities.
• Review and approve promotional materials. 
• Ensure regulatory assessment and follow-up on any consequential regulatory actions for change control requests are done.
• Develop and maintain EU Regulatory knowledge of pharmaceutical regulations. 
• Ensure operating procedures for Medtronic BioPharma are available and followed.
• Develop and maintain regulatory databases, e-publishing, and e-submissions system.