Manorack "Rocky" Somviengxay Email & Phone Number

Netherlands

Open To Global Travel

Audit ProofingEligible QP EUPAISolutions ArchitectCompliance AdvisorQMS Architect Regulated IndustriesDue DiligenceInternal AuditsSupplier AuditsGlobal RP LiaisonGlobal QP LiaisonGlobal Regulatory IntelligenceGlobal Compliance IntelligenceGlobal Regulatory StrategyGlobal Compliance StrategyClinical StrategyBrexit StrategyClinical OperationsMarket AccessGovernment AffairsInvestor RelationsPublic RelationsCommunity RelationsPatient AdvocacyCommunity AdvocacyRA/QA/QC ManagementProject ManagementProbabilistic Forecasting Stochastic Supply Chain Management Demand SensingClinical Trial PlanningLean ManufacturingSix SigmaTech Transfer/Scale UpContinuous ManufacturingCell CultureCell TherapyGene TherapySterile Clean Room OperationsAseptic Fill FinishAPIDPFGPackaging and LabelingRegulatory LabelingArtwork ManagementControlled StorageCold Chain Circular Supply Chain ManagementDistribution and LogisticsBusiness Continuity PreparationTechnical WritingCompliance Training Leadership: Interim Management GXPGMPGCPGDPGLPGCLPGVPPVFDACFDAKFDA MFDSPMDAEMAMHRAAIFATGANIHCDCBARDARegulatory Inspection ReadinessHealth Authority CertificationProcess and Systems ValidationAlliance Partnership Customer Relationship Management Vendor ManagementInfectious Diseases TaskforcePublic Sector Advisor

Atlanta Metropolitan Area

Refugee Resettlement Education Equity Global Family Health AdvocateSomeone ready to tackle difficult problems with a smileTruth Speaker Solution SeekerDiversity, Equality, Inclusion Belonging ArchitectHarvard Trained Negotiation & Leadership Coach/MentorWellspring Certified Master Life CoachIndependent Consultant

Atlanta Metropolitan Area

Greater Boston

Vinco Pharma Solutions (VPS) is a new venture driving Business and Network Development to Audit Proof, Dionis Pharma and XCell Strategic Consulting.VPS provides a comprehensive suite of pharmaceutical services in QMS, CMC RA, QA, Supply Chain and GXP Operations. We hand all CMC OPS within a phase appropriate QMS from inception to commercialization.• CMO/CDMO/CPO analysis, selection and management• Clinical packaging supplier selection and management through Phase III• Supplier selection and management for engineering and design, molding and electronics• API sourcing, evaluation and management• Tech transfer execution• Supply chain design, implementation and risk management• Pharmaceutical management consultation We offer the flexibility to provide support through QMS design, QA OP services, tactical consultation, managed services, staffing augmentation or a combination.

Americas

Head of External Manufacturing QA Americas provided leadership and QA expertise in driving strategic and operational Quality Assurance activities associated with Global Vendors (Contract Manufacturing Organizations) engaged in GMP manufacturing activities for UCB Products. Oversee global supply achieved through close partnering with QA management within UCB and at interfaces with Product Global Quality Leads, QA Vendor managers for vendor sites, and in collaboration with UCB Technical Operations and other UCB teams (Vendor Team, Extended Vendor Team). Global Quality Leadership role responsibility for above summarized scope of activities in relation to defined contract manufacturing located in the Americas for UCB Commercial Global Supply Chain, Logistics and Distribution.

Greater San Diego Area

Sr. Director of Quality at Sherpa Clinical Packaging, PCI. Head of QA/RA for all plant operations, specializing in providing Clinical Trial Material management services, including packaging, labeling, distribution and returns reconciliation, for pharmaceutical, biotechnology, medical device, in-vitro diagnostics and dietary supplement companies. Sherpa utilizes cGMP compliant systems and facilities to manage the packaging and labeling, cold chain management and logistics to support the clinical supplies needs of our clients of all sizes. Ensuring business continuity and disaster preparedness on our clients behalf to maintain the flow of manufacturing and integrity of critical temperature controlled storage. Program Management, Quality Systems, Regulatory Compliance,Change Control, Risk Based Validation, establish Audit Program, Conduct Internal, Vendor Audits, Inspection Readiness, EDCS, EMS, Business Continuity, LIMS, LMS, Project Management, Computer Systems Validation, QP Liaison, Vendor Management, QMS (Quality Management System), CAPA, Operational Excellence, ITIL, PMP, Quality Analytics, Lean Six Sigma,

Cambridge, Boston

• Responsible for support of clinical trial Phase I-III material manufacture• Support Real Time Release testing and Continuous Manufacturing• Craft goal setting to best pursuit of corporate and department goals• Provide information to assist in budgeting, scheduling, & self-performance reviews• Participate in cross-functional teams in Quality expert role• Draft and enforce Quality Agreements with 3rd party service suppliers.• Assess and approve change controls related to processes, manufacturing, and analytical• Conduct quality investigations /deviations and reviews corrective action plans for adequacy and compliance. This includes root cause analysis and product impact assessments for investigations resulting from deviations and OOS. Ensures appropriate CAPA actions are identified and addressed. Approves investigations/CAPAs.• Maintain Quality Metrics to support process improvement activities• Review trend reports for product quality deviations, OOS and CAPA.• Provide strategies to address compliance gaps or determines enhancements to cross-functional quality systems• Conduct reviews of executed batch documentation from external and/or internal manufacturing and testing (executed batch records, release data, in-process controls, testing and stability data)• Perform Batch disposition for drug substance, drug product intermediate, drug product and finished goods• Interact with QPs for product releases in European countries• Conduct GMP document review, including certificate of analysis, specifications, IND/IMPD/NDA documents, methods, protocols, and method qualification/validation reports• Perform administrative activities on company software programs including QDoCCS, OPM, Trackwise and others as applicable• Support internal audit or external audit programs• Prepare audit responses• Manage audit CAPAs & metrics• Provide Subject Matter Expert support for partner and regulatory agency audits

Cambridge

Allston, Ma

Cambridge, Netherlands, Denmark

Smithfield, Ri

Boston

Boston, Massachusetts, United States

Bachelor Of Science (Bs), Biology With Honors

Activities and Societies: Honors Program Premed Conservation Environmental Science Teaching Assistant - Organic Chemistry Laboratory.

Education record

Education record

Lsat, Law

Activities and Societies: Legal training, tutoring and standardized testing preparation Reasoning, Formal Logic, Strict Sequencing.

Fsi (Forced Survival Intelligence), Refugee School Of Hardship, Survival 2021

Activities and Societies: Safety Negotiations, Empathy Translation Life of Gratitude after earning Forced Survival Intelligence (FSI)

Education record