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Work Background
HAL Allergy GroupSr. CMO Manager (ad interim)
Apr. 2019 - Sep. 2019Leiden, The NetherlandsLeadership position in building and implementing the CMO project management organization
Introduced new matrix organization plan with clear roles and responsibilities to enhance processes while ensuring quality and regulatory compliance
Developed team communications and information for project meeting
Lead innovative customers to understand the requirements and provide exceptional problem-solving services. Mentored and lead a team of 6 people and indirectly the entire operations and quality departments.
Worked with Operations and Quality to resolve compliance issues, helping the team to understand the Quality Management Systems, improving operations and providing exceptional customer service.
ambipharmFounder & Managing Director
Jul. 2018Lisbon, Portugal• Founded and led ambipharm, a consulting firm focused on driving growth in the Pharma and Biotech industries. • Spearheaded complex projects by integrating technology with strategic operations, enhancing operational efficiency. Lead matrix teams in a hybrid environment towards successful operations and exceeding expectations and goals
• Conducted GMP-GDP gap assessments and due diligence, ensuring compliance and quality assurance across organizations. • Served as a Responsible Person and GMP Auditor, reinforcing industry standards and best practices.
DSM Sinochem PharmaceuticalsGlobal Business Manager
Jul. 2015 - May. 2018The Hague Area, Netherlands*Business Management
Identify and analyze business opportunities and target key business prospects.
Defining marketing priorities and developing marketing strategy
Work out competitive landscape, generate market dynamics and trends
Leading global marketing activities
Developing sales and marketing materials
Responsible for P&L & KPIs
Responsible for setting up price strategy
Steering, providing indirect supervision and business guidance of all relevant functions/disciplines such as regionally organized, marketing & sales; sourcing and purchasing; manufacturing; demand supply chain; demand planning; R&D; TT; BI; RA; Legal and QA
Train and coach interns and new hires *Business Development
Establish and nurture relationships that fill business pipeline with prospective partners and customers. Negotiate new partnerships and business alliances, work closely with legal experts to write contracts for new business partners
New product introduction (NPI)
Develop strategy for pipeline expansion, portfolio broadening and forward/backward integration within the product family *Project Manager/Director
Responsible for the development, scale-up, commercial launch, and the day-to-day operations after the commercial launch for a certain product portfolio or product/market combination (PMC)
Identify road blocks and drive new business from conception through closure and life-cycle management
Management of project team (local & virtual), Focal point in a complex cross matrix/ cross functional environment Defining and executing project plan, communication plan, allocate task and setting milestones
Due diligence of 3rd parties
DSM Sinochem PharmaceuticalsGlobal Business Manager (Interim)
Nov. 2014 - Jul. 2015The Hague Area, NetherlandsIdentify and analyze business development opportunities for DSP. Work out competitive landscape, Generate market insights, competitive intelligence
developing/ executing global business plans/marketing plans
Actively build external network
Responsible for setting up the price strategy
Supporting training sales force
Work out long term business strategy (BSD) (full portfolio) for BU DP within DSP.
Leadership position working with cross-functional/cross-divisional teams
Launch new products, S&OPs
Main focus SSP's.
DSM Sinochem PharmaceuticalsInternational Regulatory Affairs Manager
Sep. 2013 - Nov. 2014The Hague Area, Netherlands*Regulatory Affairs
Provide guidance and strategy of drug product registration (worldwide)
Write registration dossiers as per business needs (DCPs). Lifecycle management, gap analysis (variations, duplicates). Launch preparations
Pharmacovigilance *Compliance & Auditing
Due diligence of regulatory dossiers
Audit of external partners (e.g. CMOs) Main focus: oral dosage forms
Hikma PharmaceuticalsGroup Leader, Technology Transfer & Regulatory Affairs
Nov. 2011 - Aug. 2013Lisbon Area, Portugal*Technology Transfer
Leadership position in TT of Drug Products from R&D-Scale Up- until product registration, launch and post launch Oncology drugs German site *Regulatory Affairs
Responsible for Regulatory Strategy
Provide guidance and strategy of drug product registration (CMC, DP & DS). Write registration dossiers as per business needs (ANDA, ANDS, others) Labeling, image change of US portfolio
Product launch
Lifecycle management (Supplements, and Annual Reports).
Improvement processes
Field Alerts & Recalls
Train and coach interns and new hires *Compliance & Auditing
GMP Quality Systems compliance Audits as part of quality compliance assurance program. Facilitating FDA inspections and other Health Authorities within the sites. Internal auditor
Due diligence of dossiers and suppliers
Draft of Quality agreements with API suppliers
Write, Evaluate and Execution of Change controls
Write, Review, Approval of Protocols and Reports: e.g. Stability, Validation, Production, QC, QA, TS, i.e. MBR, IPC, Filter Validation, Media Fills, others)
Improvement process of QC-QA-Production documentation e.g. Specifications, SOPs, MBR (IPC), others *Other Activities
AdHoc activities as per business needs
Coordination between Regulatory Compliance and Quality Unit (i.e. Operations, DSCM, QC/QA, M&S) S&OPs Injectable segment, Generics
Hikma PharmaceuticalsRegulatory Affairs Specialist (US Market)
Aug. 2008 - Nov. 2011Lisbon Area, Portugal
Generis Farmaceutica SAQuality Assurance & Control
Nov. 2007 - Jul. 2008Lisbon Area, Portugal
The Coca-Cola CompanyQuality Assurance
Jun. 2007 - Aug. 2007Massachussetts, United StatesInternship
Fildom, LdaQuality Assurance Manager/ Board of Administration
Sep. 1999 - Aug. 2005Lisbon Area, PortugalFamily owned company
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