Jonathan Malave


Results-oriented, high-energy, hands-on professional, whose major strengths include effective leadership, adaptive skill sets, efficient communication, attention to detail, and dutiful respect for compliance in all regulated environments, with a successful record of accomplishments within the pharmaceutical and medical device industries. Experience in the development, manufacturing, and release of various immediate and controlled release dosage forms, such as tablet, capsule, topical, and suppository dosage forms, single and multiple active, proprietary combination, abuse-resistant, opioid, autoimmune disease, immune-mediated inflammatory disorder, immunosuppressive, antipsychotic, and anemia drug products, and medical device products.



  • Project Leadership / Project Management / Project Planning / Project Scheduling / Gantt Charts / Project Execution
  • Communication Planning / Project Risk Management / Issue Reporting / Stakeholder Reporting
  • Supply Chain Processes / Packaging Operations / Logistics Processes / Distribution Processes
  • Change Management / Corrective and Preventative Action / Design Control / Risk Management Planning / Risk Analysis
  • Controlled Temperature Shipping Solutions / Requirements Definitions / Thermal Equivalence / Technical Justifications
  • Controlled Temperature Shipping Qualifications / Package Material Testing / Packing Instructions / Bill of Materials
  • FDA 21 CFR Part 820 / FDA 21 CFR Part 210 / FDA 21 CFR Part 211 / FDA 21 CFR Part 11 / ISO 9000 / ISO 13485
  • Medical Device Directives (MDD 93/ 42EEC) /Canadian Medical Device Regulation / Drug Enforcement Agency Law
  • Process Verification / Process Qualification / Process Validation / Analytical Methods / USP Methods
  • Facility Validation / Manufacturing Equipment Validation / Analytical Equipment Validation
  • Root Cause Analysis / Nonconforming product Handling / Complaint Investigations / Medical Device Reporting
  • Site Investigations / Supplier Investigations / Laboratory Investigations / Deviation Handling
  • Internal Audits /External Audits / FDA Audits /ISO Audits / Vendor/Supplier Audits
  • Quality System Implementation / Procedural Development / Work Instructions / Training Programs
  • Labeling Issuance / Labeling Review / Labeling Approval / Labeling Control / Labeling Change Control
  • Document Control / Laboratory Notebook Control / Raw Data Handling /Batch Record Control
  • Annual Product Reviews / Product Annual Reporting for New Drug Applications/Abbreviated New Drug Applications
  • PDEA ARCOS Reports / Year End Reports / Controlled Substance Quota Requests
  • Certificates of Analysis (COA) / Certificates of Conformity (COC) / Certification/Recertification COA/COC
  • Environmental Monitoring / Air Particulate Monitoring /Viable Organism Monitoring / Water Monitoring
  • Analytical Instrumentation (HPLC / GC / UV / Dissolution I-III / AA / Viscometer)


  • Led and managed global market transition initiative for multiple drug products, devices, and presentations to establish equivalency between new cold chain shipping solutions and previously qualified containers based upon leveraging justifications
  • Directed efforts to identify and implement cold chain shipping solutions with respect to various countries and markets based upon project schedule
  • Managed endeavors to confirm that project scope adequately defined, develop key event maps, and verify milestones for global harmonization project
  • Guided team to ensure proper communication of inter-company and affiliate concerns and requests with respect to controlled temperature shipping solutions
  • Facilitated global change control efforts to support ongoing market transition projects
  • Led and managed efforts to establish equivalency of gel pack components to support supplier change request being implemented as part of cost saving initiatives, coordinating efforts to conduct required material testing, tensile testing, qualification testing, and statistical analysis, necessary to transition from old to new components
  • Led initiative to reduce processing time for investigations, deviations, complaints, SOPs and validation documents to meet compliance and production requirements, thus resulting in an increase in on-time results from 50% to 96%
  • Managed effort to decrease cycle times for investigations, and their related corrective actions/preventative actions to meet current industry practices, thus resulting in an increase in on-time results from 70% to 95%
  • Led QA department in regulatory body and agency inspections in response to multiple FDA 483 deficiencies, along with ISO notifying body nonconformance’s
  • Drove 38+ CAPAs, and numerous nonconformances, to effective closure, with many associated with systemic deficiencies (stability failures/validation/sterilization/labeling/training/CAPA/nonconformance/internal audit/packaging)
  • Managed and brought into compliance corporate-wide label system project that included input/output process and flow-mapping of all label systems, including internal label request/production/issuance process, label review, and approval process, maintenance and management of all master label documentation, and protocol development, along with harmonization of all relevant off-site facilities
  • Directed staff consisting of Quality Engineers, DEA specialists, QA specialists, QA reviewers, and QC supervisors
  • Monitored contract manufacturers, packagers, laboratories, and component suppliers to insure ongoing regulatory compliance
  • Revised, approved, and issued master batch records to encompass entire operation, improving manufacturing time and efficiency
  • Established robust CAPA review, and materials management boards, within bi-weekly meetings to insure dissemination of status to all relevant management
  • Implemented and utilized root cause analysis/risk management tools to establish proper effectiveness checks within CAPA systems, along with development of failure mode/root cause coding system to more accurately identify negative trending as applied to quality metrics
  • Worked in concertion with international establishment to research and develop proprietary product, safely viable for human application, which turn a profit margin ranging from approximately 400% to 700%
  • Implemented health and safety policy, maintained insurance policy and tax filing, managed financial, marketing, sales-consultations program, internal documents development, technical operations management, and product research and development information and activities
  • Developed and maintained strong working affiliations with medical doctors and professionals in order to help resolve patient symptoms directly related to adverse biological afflictions (e.g. Lupus, Trichotillomania, Chemo/Radiation Therapies, Alopecia, etc.)
  • Developed and managed strong, lasting relationships with clientele and established a near zero turnaround ratio within customer base


  • Quality Solutions Now (QSN) (Emmaus, PA) – Consultant – 2011 to Present
  • Elite Pharmaceuticals (Northvale, NJ) – Manager, QA & Compliance – 2009 to 2011
  • Quality Solutions Now (QSN) (Bethlehem, PA) – Consultant – 2008 to 2009
  • IVRX Pharmaceutical Solutions (Springfield, NJ) – Manager, QA & Compliance – 2006 to 2008
  • A’jon IHD (Morristown, NJ) – President – 2004 to 2006
  • AAIPharma Services (North Brunswick, NJ) – Quality Assurance Specialist – 2001 to 2004
  • Warner-Lambert (Morris Plains, NJ) – R&D/Quality Design Chemist – 1998 to – 2001


  • Bachelor of Science, Biology/Pre-Medicine, Monmouth University, West Long Branch, NJ – 1994-1998 (Pre-Medicine curriculum with multi-year acceptance into the University of Medicine and Dentistry of New Jersey (UMDNJ) summer medical school preceptorship program)