A. Santos
Director of Quality & Operations | CAPEX Projects
Salaire / Taux journalier
Lausanne, Suisse
Freelance
Expertises
Langues
À propos
Introduction
Operations Director with 20+ years driving quality excellence and CAPEX projects in biotech, pharma, and medtech. Led Centre of Excellence delivery at Moderna, improved delivery rates to 97% while cutting quality costs by 50%, and scaled QA pass rates from 54% to 90%. Specialized in operational transformation, regulatory compliance, and new product launches across EU/US markets with proven results in GMP/GDP environments.
Expérience de travail
Director
CDMO
janv. 2024 - Présent
2 ans 10 mois
1422 Grandson, Suisse
Quality Operations and Capex Project Director - New center of Excellence, Quality Control Laboratory
Moderna
juin 2021 - déc. 2023
2 ans 7 mois
1422 Grandson, Suisse
Led the Capex and QA Operations for the new Centre of Excellence in Madrid.
Operations Director, QA Compliance, Business Development - Biotech, MedTech - Dental, Orthopedics
Wellsept
janv. 2019 - mai 2021
2 ans 5 mois
Lausanne, Suisse
- Developed and managed markets for devices and pharma manufacturing. - Oversaw risk assessments, SOP creation, and health authority inspections. - Led a Capex construction laboratory. - Trained internal and external teams.
VP of Operations – New drug and devices introduction, Capex Project, QA Compliance
Duo-Sinucort - Biotech
janv. 2010 - déc. 2018
9 ans
Genève, Suisse
- Drove all the out license negotiations, achieving the highest results. - Led GMP/GDP supplier relationships, QA contracts, and product quality. - Directed regulatory responses for EU, US, and Russian product registration. - Oversaw compliance documentation and internal training. - Led Tech Transfer to new industrial Pharma Partner.
Managing Director, Business Operations, Clinics & Laboratories Operations, Supply Chain, QA
Easymed SA
févr. 2008 - déc. 2009
1 an 11 mois
Sion Area Switzerland
- Introduced new strategy and tactics to approach the MedTech markets with new implants, biomaterials and systems across all Europe (Orthopedics (Spine) and Dental). - Improved delivery from 80% to 97% and reduced quality-related costs by 50%. - Drove new clinics and laboratory Capex projects in Switzerland and Belgium. - Led equipment and consumables procurement.
Marketing Manager, NPIs, Product Development Lead, Business Operations, Training & Empowerment
PDSA
janv. 2006 - déc. 2007
2 ans
1800 Vevey, Suisse
- Supported launch of UDI traceability tools and CE-marked devices as PD Vitalos Cement (Biomaterial). - Created multilingual packaging/IFUs for the global market.
Founder & Quality Director - Consulting on New Products and Markets Launch
mqm consulting
janv. 1998 - déc. 2005
8 ans
Région de Lausanne, Suisse
- Developed internal quality teams and improved QA pass rates from 54% to 90%. - Managed audits, SOPs, and regulatory operations for biological APIs. - Qualified a new Italian Distributed, training all their teams (220 persons) on an Infection Control large products line.
Formation
Challenge Optimum Institute
Project Management Lean & Six Sigma Green Belt, Project Management
2015 - 2016
2 ans
Challenge Optimum Institute
Internal Audits Certification, Quality systems Internal Auditing
2015 - 2016
2 ans
Challenge Optimum Institute
Risks Management Certification, Risks Management
2015 - 2016
2 ans
IFCAM - Business Administration Institute of production & services companies
MBA Equivalent – Business Administration, IFCAM – Switzerland, Business Admnistration, Sales, Marketing, Business Planning, Production, Accounting, Human Resources
2000 - 2016
17 ans
Optimum Institute
Quality Management Engineering, Quality Assurance
SAWI - Swiss Institut for MarCom Management
MBA Equivalent – Marketing Management, Marketing Management
Licences et certifications
MS Project 2021
Délivré le : févr. 2025
Agile Scrum Certifications
Délivré le : janv. 2025