DAVID L. HYDE
27 Katherine Way
Plaistow, NH 03865
 [Send email to request phone number] 82-0179

PROFILE

A results-oriented Quality Assurance and Operations professional with proven
quality management, compliance consulting and operations experience. Possesses
the drive, ability and organizational skills to accurately assess situational
needs, and then develop pragmatic and cost-effective solutions. Results obtained
are improved quality, efficiency, and productivity, combined with compliance with
FDA regulations, industry practices, and company standards. Expertise
encompasses:

  ˜ Quality Systems Management
  ˜ Laboratory Operations
  ˜ Process Improvement / Productivity Optimization
  ˜ Auditing / Benchmarking:
 o Quality Systems
 o Suppliers / Vendors
 o Manufacturing Processes
 o Training Programs
 o Equipment Qualifications / Process Validations
  ˜ Equipment Qualification and Process Validation
  ˜ CAPA Planning, Execution and Management:
 o Document Review, Preparation and Optimization
 ‚  Policies and SOPs
 ‚  Batch Manufacturing Records
  ˜ Compliance Consulting:
 o 21CFR Parts 210 & 211, 820, 606 and 11
 o ICH Q7A and Q9
 o FDA Action Remediation Planning and Implementation

SUMMARY OF RESPONSIBILITIES

  ˜ Established and implemented QA/QC, Validation, and Manufacturing systems /
programs / documentation to improve product quality, increase process efficiency,
reduce cycle time / waste / rework / retesting, and limit compliance risk. Where
appropriate, investigated emerging technologies and processes (e.g., PAT).
  ˜ Developed manufacturing batch records and quality control test records,
including accurate process steps, process parameters / quality attributes,
employee training, raw data review / approval for release, handling of
deviations, etc.
  ˜ Performed supplier qualification audits to assure quality, compliance, and
ability to consistently meet specifications, including providing technical,
quality and/or regulatory assistance where needed.
  ˜ Directed equipment / instrument / system qualifications and process / method
validations, including protocol and final report review and approval, deviation
handling, corrective action execution and retesting.
  ˜ Monitored process performance and deviations, including analyzing data to
determine root cause and providing technical expertise for resolving issues and
identifying systemic corrective actions to prevent reoccurrence.
  ˜ Directed CAPA plans, including prioritizing issues, identifying actions,
assigning resources and tracking progress.
  ˜ Directed cross-functional teams performing quality and compliance
assessments, responding to FDA enforcement actions, implementing process
improvement and optimization initiatives, executing validation projects, etc.
  ˜ Identified qualifications and skill sets required based upon activities to
be performed, developed the necessary training programs and materials, and then
delivered training to employees, including evaluation of effectiveness.
  ˜ Participated actively in professional society organizations (e.g., PDA,
ISPE, ASQ) to maintain awareness of current regulatory requirements, industry
standards / trends, and best practices, including networking, participating in
interest groups and speaking engagements.
  ˜ Managed multiple client projects ranging in scope, services, duration, risk
and location, with a high level of client satisfaction reflected by expanded and
repeat business. 

PROFESSIONAL EXPERIENCE

Foster-Miller, Inc. / QinetiQ North America 2007 - Present
  ˜ Consulted with clients regarding their technology needs to:
 o Evaluate, identify, assess and prioritize technology needs and requirements.
 o Benchmark currently-available technologies to identify opportunities for
innovation (technology forecasting).
 o Recommend opportunities for Process Analytical Technologies (PAT).
  ˜ Managed the system qualification and process validation of an automated,
robotic liquid handling system within a BSC Level II laboratory environment,
including:
 o Preparation of Validation Project Plan and User Requirements Specifications.
 o Preparation and execution of IQ, OQ and PQ Protocols and Summary Reports,
including deviation resolution.
 o Coordination and documentation of operator training.

LearnWright, Inc. 2005 - 2007
  ˜ Consulted with clients regarding their internal employee Training Programs
to:
 o Evaluate, identify, assess and prioritize training needs and requirements.
 o Develop learning plans and curricula for individuals and job positions.
 o Evaluate, identify and select appropriate training content and media.
 o Plan and implement Training Program improvements.
 o Evaluate Learning Management System (LMS) User Requirements.

Thermo Electron Corporation 2004 - 2005
  ˜ Consulted with clients regarding their Laboratory Operations to:
 o Assess and address quality, compliance and laboratory needs.
 o Identify, develop, and execute value-added solutions to meet their specific
laboratory requirements.
 o Audit / Review instrument qualifications and analytical method validations.
 o Audit / Review instrument calibration, preventive maintenance and usage
documentation and programs.
 o Assess training and qualification of Laboratory Analysts.

PAREXEL Consulting Group 1991 - 2004
 - Corporate Business Operations   “ KMI / PAREXEL (1999 - 2003)
 - Compliance and Corporate Quality Systems   “ Kemper-Masterson, Inc. (KMI)
(1997 - 1999)
 - Compliance Operations - KMI (1996 - 1997)
 - Quality Assurance - KMI (1992 - 1996)
 - Validation Services - KMI (1991 - 1992)
  ˜ Directed quality plans, programs and initiatives to meet strategic goals,
including identification of tactical objectives, establishment of performance and
quality metrics, and monitoring of performance.
  ˜ Prepared and communicated plans and reports documenting various activities,
including Project Status, Audit, Corrective Action, Process Improvement, Quality
Performance Metrics, Deviation and Investigation. 
  ˜ Established effective communications with colleagues, piers, subordinates,
cross-organizational teams and other stakeholders to constantly assess current
conditions and to identify potential areas of improvement.
  ˜ Managed dozens of clients / accounts / projects, including budget tracking
and adherence, control and quality of project deliverables, client satisfaction,
conflict resolution and project close-out.
  ˜ Championed a higher performance workplace by establishing a challenging
environment for a team of 23 employees (ranging from Administrative through
Senior Director), including directing development and training activities.

Millipore Corporation 1989 - 1991
  ˜ Developed and delivered multiple training / certification programs used to
educate both Millipore employees and its customers in the concepts of process
validation, FDA cGMP Regulations, filter integrity testing and sterile
filtration.
  ˜ Directed and participated in multiple process validation projects, including
membrane casting and pleating, cartridge-filter assembly, integrity testing and
bacterial challenge (HIMA) testing.
  ˜ Directed a project involving the qualification of Millipore  's Integritest
II automated filter integrity test system.
  ˜ Presented technical papers at multiple society and client seminars and
assisted Technical staff.

Polymer Technology Corporation (Bausch & Lomb) 1985 - 1989
  ˜ Developed, manufactured and tested prototype formulations for sterile
ophthalmic contact lens solutions.
  ˜ Coordinated production and quality control / stability testing of R&D
pilot-scale batches through full-scale production batches at domestic and
international facilities, including scale-up and technology transfer activities.
  ˜ Designed and validated manufacturing equipment / processes and analytical
test methods.
  ˜ Prepared manufacturing procedures, test methods and batch records, including
providing relevant training.
  ˜ Developed and implemented company-wide metrology / calibration and
preventive maintenance programs.

PROFESSIONAL MEMBERSHIPS, SPEAKING ENGAGEMENTS, AND PUBLICATIONS

  ˜ Memberships - PDA, ISPE, ASQ, RAPS, and AAPS
  ˜ Author   “ Achieving a World-class Quality Training Program, in NextGen
Pharmaceutical, 2007
  ˜ Speaker - Validation   “ A Manufacturer  's Perspective, Thermo Electron
Corporation, 2005
  ˜ Speaker - Documentation Needed for Validation, Institute for Packaging
Professionals, 1997
  ˜ Speaker - An Optimized Approach to the Validation of Computer-related
Laboratory Systems, ISLAR, 1996
  ˜ Speaker - Filter Integrity Testing, Parenteral Drug Association, 1990
  ˜ Speaker - Validation of Filter Manufacturing Processes, Millipore Client
Symposium, 1990
  ˜ Speaker and Co-author - The Matrix Approach: Microbial Retention Testing of
Sterilizing-Grade Filters with Final Parenteral Products, Part II, in
Pharmaceutical Technology and Millipore Client Symposium, 1991

EDUCATION

Bachelor Degree - Biology - Colby College, Waterville, Maine   “ 1983

REFERENCES

Furnished upon request.