Diana Santos Email & Phone Number

Lisbon, Pt

Lisbon, Portugal

• Lead GxP audits across global regulations (Swissmedic, FDA, EMA, MHRA, PMDA, ANVISA) with expertise in sterile manufacturing, combination products, and biological products.Member of the Employee Resource Group, promoting diversity, equity, and inclusion through workplace initiatives.• Drive high-performing team development by fostering trust, collaboration, and accountability. Provide mentorship, training, and effective communication to enhance team performance.• Deliver due diligence assessments to support investment decisions in M&A, acquisitions, and licensing deals. Lead Quality Agreement initiatives and strengthen partnerships with top global pharma suppliers.• Represent QA in CMC global project teams, aligning global program strategies and liaising with internal and external stakeholders worldwide.• Lead Inspection Readiness strategies, ensuring risks are identified and addressed through corrective actions.

Basel, Switzerland

• Team Leader of Novartis' consulting team and Global Technical Project Manager (R&D Project & Portfolio Management).• Led CMC team activities for Biologic programs (AMG334, CFZ533), developing and executing CMC strategies to drive project progress and ensure milestones were met.• Fostered a high-performing team culture with trust, collaboration, and accountability. • Mentorship: mentored junior project managers and optimized communication across CMC teams and external partners.• Coordinated clinical trial supply operations, including CMO oversight, site coordination, and supply chain process streamlining for ongoing and upcoming studies.• Oversaw portfolio and budget reviews, liaising with finance for project cost tracking and resource allocation.• Directed operational management of CMC Biologics projects, coordinating multidisciplinary teams (API, Drug Product, QA, QC, Regulatory, Supply Chain) to align with strategic goals.• Collaborated with Global Clinical Supply teams to manage forecasts, clinical demands based on real-time study data and inventory.• Implemented strategic initiatives as part of the PMO, using risk management and project management tools to drive alignment and prioritize goals.• Delivered project management consultancy, identifying improvement areas and applying process excellence, governance, and digital PM tools to ensure project success.

Basel Area, Switzerland

Basel Area, Switzerland

• 01/2019 – 12/2019 Novartis Pharma AG: Global Project Manager - TRD Biologics Project & Portfolio Management (Neuroscience, Immunology and Oncology).• 10/2018 – 12/2018 Janssen Vaccines: Assessment and diagnosis of the change management and change notification process. Built a new digital risk-based Supplier Change Notification database to prioritise the changes and improve performance.

Basel, Switzerland

Pharmaceutical Drug Development / Launch Project Management (R&D Biologics Portfolio Management)• Led CMC team activities for Biologic programs (AMG334, CFZ533), developing and executing CMC strategies to drive project progress and ensure milestones were met.• Fostered a high-performing team culture with trust, collaboration, and accountability. • Mentorship: mentored junior project managers and optimized communication across CMC teams and external partners.• Coordinated clinical trial supply operations, including CMO oversight, site coordination, and supply chain process streamlining for ongoing and upcoming studies.• Oversaw portfolio and budget reviews, liaising with finance for project cost tracking and resource allocation.• Directed operational management of CMC Biologics projects, coordinating multidisciplinary teams (API, Drug Product, QA, QC, Regulatory, Supply Chain) to align with strategic goals.

High Wycombe, England, United Kingdom

• Managed information flow with third-party suppliers, ensuring compliance with regulatory dossiers and cGMP through all stages of the product lifecycle.• Led audits of third-party CMOs and vendors, driving adherence to quality standards and regulatory requirements.• Directed key strategic initiatives for third-party manufactured products, ensuring alignment with operational and business goals.• Conducted due diligence assessments for M&A, acquisitions, and licensing deals, supporting critical investment decisions as a member of the M&A Board.• Promoted continuous improvement and change management to optimize efficiency in third-party finished products.• Provided technical expertise to supply chain and strategic alliances teams, assessing new vendors and managing Quality Agreements and Product Quality Reviews.• Collaborated with Supply Chain and Commercial functions to oversee supplier performance and ensure seamless commercial operations.• Reviewed and approved key quality documents, including manufacturing records, validation protocols, stability protocols, change controls, and deviation reports, ensuring compliance with regulatory and quality standards.

Welwyn Garden City, England, United Kingdom

• Drove GCP/GVP QMS workstreams, aligning with UK Medical and Clinical strategy to meet QMS objectives.• Coordinated QMS strategic initiatives, including KPI reporting, trend analysis, and preparation of QMS Quality Reports for Management Reviews.• Led operational medical compliance and QMS projects, guiding teams through strategic initiatives and fostering continuous improvement.• Directed the QMS Training workstream, integrating new systems, identifying digitalization opportunities, and ensuring compliance across Medical Affairs, Regulatory, Safety, Quality, and Clinical teams.• Implemented core GCP/GVP QMS requirements, covering document management, CAPA and deviations, KPI oversight, service provider management, and inspection readiness.• Managed the QMS Risk Register, ensuring risks were captured and mitigated with proactive solutions to maintain high compliance rates.

Lisbon Area, Portugal

• Led the harmonization and implementation of QMS between GSK and ViiV Healthcare, maintaining a high level of QMS knowledge to proactively address business challenges and opportunities.• Managed and developed a high-performing QA team, overseeing batch documentation reviews, deviation and complaint management, and fostering a culture of quality excellence and continuous improvement.• Developed strategies to enhance quality culture, delivering effective training and driving QMS compliance across the organization.• Promoted process excellence and continuous improvement aligned with leadership objectives, conducting impact assessments and implementing QMS policy updates.• Established and monitored QA objectives and KPIs, presenting performance insights to the CEO and executive committee. • Managed Annual Quality Plans and ensured compliance with local regulatory requirements, including change control, risk management, and incident management.Conducted supplier and service provider audits to ensure product quality.• Oversaw Quality Agreements and liaised with manufacturing sites and contractors to ensure compliance with local regulatory and technical requirements.• Collaborated with Global Business Process Owners (GBPOs) to identify training needs, address deployment gaps, and contribute to the QMS improvements to enhance product quality and operational effectiveness.

Lisbon, Portugal

• Business partnership of the therapeutic areas and different departments (IT, DRA, BUs, PV, Supply Chain, Clinical Trials, Medical Affairs, Marketing, Market Access, Customer Services). Promoted QMS management principles and quality culture as per Quality strategy defined and presented to the Portuguese Country Head and executive committee.• Certified Investigator by Novartis according to the standards in place; Rolled out the GxP training matrix, defining new digitalization opportunities across the CPO that can generate value and ensure the training compliance. Management of training, ensuring that training curricula, job profiles were properly implemented and that all GxP areas training was performed. • Pharmaceutical Anti-counterfeiting Expert within Novartis Organization: Rolled out and implemented of Global project locally; Planed and performed trainings for all involved people, vendors and departments. Created and implemented SOPs and work instructions, ensuring the processes simplification; Created digital simplification solutions in Quality systems and processes aligned with Quality Plan and Leadership strategy.• Ensured the correlation of pharmacovigilance with the technical complaints. Managed KPIs and collaborated in audits and self-inspections.

Doctor Of Pharmacy - Pharmd, Pharmaceutical Sciences

Doctor Of Pharmacy (Pharmd), Pharmaceutical Sciences, Msc

Activities and Societies: XIV Course for Education Mediators in AIDS, STIs and Drug Addiction and respective Street Campaign. Development.