Compliance Risk Management ("CRM") provides consulting services to the Pharmaceutical industry. CRM focuses on the application of risk management principals in the development of solutions to challenges facing both established and growing pharmaceutical companies. FDA has released several "Guidance for Industry" documents covering expectations for Pharmaceutical Development (Q8), Quality Risk Management (Q9), Pharmaceutical Quality System (Q10), and Development and Manufacture of Drug Substances (Q11). These Guidances speak to the role that risk management practices should have in the development and execution of drug development, process validation and ongoing drug product manufacturing. These documents, coupled with the Process Validation Guidance for Industry show how increasingly important the application of risk management principals are to both FDA and the pharmaceutical industry.

* Responsible for Validation programs for commercialized drug products including validation master planning, equipment qualification, and process and cleaning validation.* Responsible for the departmental SOP generation and revision.* Responsible for the management and operation of the commercial change control system.* Responsible for validation project management, integrating internal resources and Contract Manufacturing Organizations (CMOs).

* Responsible for the establishment of the Validation Department including development of departmental policies and procedures, budget development and staffing.* Responsible for the development of validation master plans, commissioning procedures, IQ/OQ/PQ and CSV and PV protocols for a manufacturing plant build-out in Tewksbury, MA.* Responsible for the hiring and supervision of commissioning and validation contractors.

* New England Regional Manager responsible for the start-up of a new office. Responsibilities include sales & marketing, preparation of proposals, and resourcing for equipment qualification projects for the Biotechnology, Pharmaceutical, and Medical Device industries.* Overall responsibility for the generation/approval/execution of Validation Master Plans, Commissioning procedures, and IQs, OQs, and PQs for specific projects. Other duties include conducting cGMP audits, coordination of Clinical Trial supply line activities, and packaging and distribution qualifications.* Supervisory responsibilities including hiring, performance appraisals, salary adjustments and departmental profit & loss.

* Department Manager responsible for Sales, project definition, and resourcing of Equipment Validation projects for Biotech and Bulk Pharmaceutical installations;* Responsible for the generation/approval/execution of Validation Master Plans, Commissioning procedures, and IQs, OQs, and PQs. Representative systems include Facility IQ, Mills, Hydrogenator, Filters, Reactor Systems, Vacuum Dryer, HVAC, Nitrogen Gas, USP & WFI Water, and solvent storage & distribution systems.* Supervisory responsibilities including hiring, performance appraisals, salary adjustments and departmental profit & loss.

* Department manager responsibilities for Packaging and Process Validation including budget projections and strategic and tactical planning;* Team leadership responsibilities for both new product on-load and process improvement projects;* Familiarity with FDA medical device submissions and regulations including cGMP requirements;* Supervisory experience including performance appraisals and salary adjustments for exempts and non-exempts.

* Responsible for manufacturing expansion project to double production capability;* Managed all budgetary, technical, and resourcing issues;* Designed, specified, and purchased process equipment for computerized manufacturing scale-up.

Process Development.Technology Transfer.Analytical Testing.