QA PMO & BD&L Lead

at  Sandoz

DEGREE OR PHD IN LIFE SCIENCES, PHARMACY OR MEDICINES. DEMONSTRATED EXPERIENCE OF SUCCESS LEADING AN ORGANIZATION OR PROJECT OF HIGH IMPACT.

• 8-12 years of Quality Assurance experience and involvement in regulated activities; broad understanding of global expectations of Health Authorities in GxP.
• Experience at Site and/or Sandoz Country Quality level is required. Deep understanding of Change Control System, Complaints, Deviation and Country Product Release, in particular for commercial products. Regulatory Affairs knowledge is also required.

YOUR KEY RESPONSIBILITIES:

Your responsibilities include, but not limited to:

• Act as sounding board for exploring opportunities for simplification and optimisation to bring compliance and performance to the next level. Act as SPOC of Commercial Quality in global projects such us launches , BD&L, mergers, acquisitions, and OpEx initiatives.
• Facilitate and provide project management support to Global and Country work streams; Lead business analysis, process modelling and re-engineering, and explore / utilize technology solutions. Perform QA due diligence for products to be acquired and manufactured at Third Party CMOs, identify Risks, prepare risk report and propose adequate mitigations while maintaining the needed confidentiality.
• Facilitate QA Risk based decision making by assessing Global, Regional and Local BD deals and providing timely and accurate feedback to business stakeholders. Support supply chain evaluation of products at early stage to ensure product can be commercialized at the identified CMO with valid GMP certifications and Regulatory Compliance.
• Identify critical quality issues in the due diligence ensuring adequate communication / escalation and resolutions of issues or mitigation of the potential compliance gaps identified during deal evaluation.
• Lead / participate in projects / initiatives and ensure that all aspects of simplification and complexity reduction are implemented and followed up. Support development, implementation and continuous improvement of globally standardized data, processes, procedures and standards encompassing Commercial QA responsibilities.
• Manage critical quality issues (deviations, complaints, recalls, counterfeits and product tampering, stability failures, etc) according to the Quality Agreement and the Quality Manual. Ensure investigations are correctly executed and all required actions are taken appropriately and in a timely fashion.
• Escalate any issues or instances of instability per the escalation policy. Support / participate in Emergency Management cases as required. Ensure that Change requests, either from the External Supplier or from Sandoz, are managed according to the Quality Agreement and SOPs from receipt, through to the implementation and closure.
• Establish regular review and assessment of KQIs at the Sandoz regional and cluster level governance meetings. Facilitate early and fast communications between commercial and QA functions, driving the necessary urgency related to potential stock outs and loss of sales. Facilitate the transfer of knowledge, QA activities, project status from the countries to be presented and discussed during regional meetings or other venues.