Careers that Change LivesAs Head of BioPharma, you will be the General Manager of Medtronic BioPharma, maintaining a management structure and ensuring compliance with all applicable regulations for 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.Ensure 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 the pharma sales organization with all applicable regulations.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 it into 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,



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.An appropriate documentation system is deployed and implemented including 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, reviewing and approving risk management plans for products 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 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):• Establish submission timelines and manage the timely receipt of information required to meet submission target dates.• Review and determine the applicability, accuracy, and completeness of documentation for inclusion in regulatory submissions.• Organize and lead the submission and approval for MA in national, mutual recognition, decentralized, and centralized procedures.Coordinate and support CTAs,



IMPDs.Handle urgent safety restrictions and submissions of safety variations.Handle 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.Key Skills & ExperienceEducation: BSC, or Advanced Degree, in a field of science (e.g.
Pharmacy, Chemistry, Biology, Medical)Experience:Minimum of 10 years Quality Management System experience in the Healthcare industry with a minimum of 5 years in a pharmaceutical environment.Experience with European and Swiss Competent Authorities inspections.Familiarity with EMA Regulatory frameworks, GMP, GCP,



and other industry standards.Works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors.
Exercises judgment within broadly defined practices and policies in selecting methods, techniques, and evaluation criteria for obtaining results.People Management experience.Skill Set:Committed to meeting schedules, performance, and budget requirements.Demonstrates a commitment to excellence by delivering measurable results that equal or exceed stretch targets; customer and results-oriented.Strong interpersonal communication and presentation skills.Strong analytical skills and data-driven.Experience in communicating with Competent Authorities.Strong people management, negotiation, and conflict resolution skills.Medtronic offers a competitive salary and flexible Benefits Package.
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