Leads and executes activities for the Device Quality function supporting software applications classified as medical devices (SaMD), software in medical devices (SiMD), and ensures quality and regulatory standards are met; provides quality support and oversight for entire software device lifecycle; acts as the Deputy Person Responsible for Regulatory Compliance (PRRC) for TPUSA and subsidiaries; accountable for compliance of commercial and clinical software application devices and combination… Show more Leads and executes activities for the Device Quality function supporting software applications classified as medical devices (SaMD), software in medical devices (SiMD), and ensures quality and regulatory standards are met; provides quality support and oversight for entire software device lifecycle; acts as the Deputy Person Responsible for Regulatory Compliance (PRRC) for TPUSA and subsidiaries; accountable for compliance of commercial and clinical software application devices and combination products for global markets, including timely completion of vigilance assessment activities, investigations, and associated incident escalation & CAPA activities Show less

Senior Quality and Technical professional who develops and has stewardship of the overall device and combination product quality strategy to maximize the benefit and sustainability of Takeda’s in-line products and to bring Takeda’s pipeline products to a sustainable existence on the market.

Continuation of Shire role (Takeda acquisition of Shire). Executes activities for the Quality function supporting software applications classified as medical devices including, but not limited to, supporting all phases of design and development and product support processes. Provides support for the assessment and execution of associated regulatory submissions.

Executes activities for the Quality function supporting software applications classified as medical devices including, but not limited to, supporting all phases of design and development and product support processes. Provides support for the assessment and execution of 510K submissions.

Provide QA support to develop and maintain effective Information Systems and Shire Quality standards within Shire Pharmaceuticals, ensure compliance with the relevant standards (e.g. 21 CFR Part 11, EU GMP Annex 11) and Shire’s Quality Standards, assist in regulatory inspections and internal audits, initiate or revise policies/SOPs as appropriate.As certified Auditor, lead both internal and external audits on behalf of Shire.

System manager/owner, designer, business analyst for global TrackWise application space.

Designer, project manager, and lead implementer for global TrackWise implementations.

Provided technical project leadership and consultation to global pharmaceutical company (the client) for global QMS implementations.

Supported and streamlined multiple downstream data systems for global Delivery and Order Management organizations. Worked as part of a global design team based in Schwalbach, Germany, to create online web order management tool.