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Thomas Lindsay
Sr. Validation Specialist
Tom has 22 years experience as a senior manager in the Medical Device and Pharmaceutical industries. He has a proven background in project management, quality systems, and validation. His experience includes the development and installation of 21 CFR and ISO 9001 compliant systems and the implementation of FDA Consent Decree remediation. Tom has successfully led major projects and implemented leading edge technologies that consistently improved product quality, compliance, productivity, cost management, and customer satisfaction .
EXPERIENCE
Developed and executed utility, facility, and equipment commissioning and validation for pharmaceutical and medical device manufacturing facilities.
Member of 3 rd party consulting team that implemented new quality systems for a leading IVD manufacturer, which resulted in the client being found in substantial compliance and released from FDA Consent Decree.
Managed the post-FDA Consent Decree validation program for a Class III Medical Device manufacturer.
Contributed to the turnaround of the facility non-compliance remediation by successfully developing and implementing a new process qualification system and revalidating all processes and equipment.
Received FDA approval for distribution of products in 12 months.
Performed Failure Modes and Effects Analysis (FMEA) of a Class III Medical Device manufacturer’s processes, including criticality analysis, to identify critical processes and process validation requirements.
Responsible for the design and start-up of a pilot manufacturing facility for implantable solid dosage drugs used in the treatment of eye diseases.
-Coordinated construction and qualification of the pilot facility
- Purchased, installed, and validated manufacturing equipment
- Wrote manufacturing procedures for the facility and equipment
Managed the planning and coordination of the closure of an off-shore manufacturing site and the transfer of equipment, systems, and processes to a new domestic manufacturing facility.
Completed the international transfer of the $100M product line and domestic facility start-up 2 months ahead of schedule and $1.5M under budget with no impact on product availability to customers.
Lead the development and implementation of productivity improvement, process reengineering, cost reduction, and performance reporting for a $120M Medical Device business unit.
POSITIONS HELD
- Sr. Validation Specialist/Quality Consultant Bioteknica Engineering Services, Inc.
- Project/Operations Manager Bausch and Lomb Pharmaceuticals, Inc.
- Validation Manager Telectronics Pacing Systems, Inc.
- Project/Operations Manager Dade Behring, Inc.
- Manager Customer Service and Distribution Home Diagnostics, Inc.
- Operations/Materials Manager Baxter Healthcare Corporation
EDUCATION
- Randolph Macon College B.A. Business
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