(815) 685-7250 | INFO@APEXPEG.COM
(815) 685-7250 | INFO@APEXPEG.COM

Tangible Results

“Demonstrating the Capabilities”


APEX brings seasoned, professional expertise that has been demonstrated in the execution of work and delivery of results. The following represents career accomplishments of APEX Members and Partners:


  • Designed, developed, and implemented comprehensive, enterprise-wide process business solutions for business units, regions, functions, and groups. Solutions included conducting assessments, developing plans, managing resources, facilitating large working sessions, and executing implementation.
  • Designed, developed, and implemented comprehensive strategic planning processes for business units, regions, functions, and groups. Processes included assessing current state, analyzing and presenting results, facilitating creation of long and short-term direction, establishing key performance indicators, and generating action plans.
  • Drove cross-functional design, development, and implementation of numerous business processes (Product Life-Cycle, Global Commercialization, Demand Planning and SIOP Integration, Business Development, Legal, HR, Marketing, Proposals, Contracting, Sales Methodology).
  • Executed team leadership responsibility within a Corporate Business Excellence Group that provided Baldrige-based assessments, enterprise-wide improvement initiatives, Lean Six Sigma tool support, and Green/Black Belt training and coaching.

R&D / Engineering

  • Developed and implemented complete life-cycle Product Development Processes fully compliant with ICH and QSR requirements, using collaborative facilitation techniques to align organization-specific roles and responsibilities.
  • Held technical and executive responsibility for building, staffing, and maintenance of state-of-art laboratories incorporating FDA, ICH, and USP guidelines.
  • Provided industry-leading expertise in chemical structure determination, analytical method development and validation.
  • Provided leadership and management of pharmaceutical Stability Operations and Documentation systems.

Manufacturing / Service

  • Provided leadership and management in Class IIb device manufacturing including Line Operations Management and Line Optimization, Value Stream Mapping and analytics, Performance Metrics, Continuous Improvement, and documentation architecture.
  • Provided technical development and execution of pFMEA, control plans, work instructions, and inspections.
  • Provided leadership and management in Pharma (API) manufacturing including Line Operations, Critical Systems, & Support Labs with in-depth cGMP / ICH expertise incorporating regulated documentation (batch records, DMF, etc.).
  • Led facility start-up and expansion projects, including piloting and validation (IQ, OQ, PQ).
  • Designed, developed, and implemented Supplier Management programs (Audit, SNC, NCR, CAPA) based on Global Harmonization (GHTF) guidelines and the QSR.

Quality Management / Operations / Engineering

  • Warning Letter remediation of multiple quality system processes including a new Quality Manual and program management over projects spanning multiple departments and manufacturing lines.
  • Provided technical leadership of production and process control elements including pFMEA, validation projects, and manufacturing procedures and work instructions.
  • Designed, developed, and implemented Quality System processes through cross-functional facilitation, business process excellence methodologies, and technical writing.
  • Provided Quality Engineering and Design Assurance support for product launch, design transfer, verification, validation, and risk management.