James Martin Email & Phone Number

Clayton, NC, US

Hatboro, Pennsylvania, US

As the Operations Manager for the Raleigh, NC office I work with our management team to assure business processes are in place and are properly utilized. As a Computer Systems Validation (CSV) Subject Matter Expert (SME) / Project Manager I work with clients to plan, implement and monitor their validation strategies in the highly regulated life sciences.

Boston, MA, US

• Developed, implemented and directed an efficient and effective risk-based Quality Management System (QMS) and Computer System Validation (CSV) program for a core network and associated applications designed with.
• Managed several concurrent Validation projects (internal and external staff and supporting resources) including in-house developed systems as well as COTS using a risk-based approach.
• Successfully launched an entire QMS including a software development lifecycle (SDLC) program based on ISO, ICH, Agile and GAMP methodologies meeting GxP Regulations. Process included over 30 policies and standard.
• Implemented a Patient Privacy and Security program meeting GxP, HIPAA and GDPR requirements including registration with Safe Harbor and Privacy Shield.
• Oversee training, documentation management, internal audit, and corrective action process.
• Hosted external audits (75+) for clients comprised of the largest, global pharmaceutical companies such as Glaxo-SmithKline, Astro Zeneca, Novo Nordisk, Merck and Contract Research Organizations such as IQVIA and ICON..

Marlborough, MA, US

(Through a contract with Kelly IT Services)In coordination with the business user community and Information Technology (IT) validated or assisted with the validation of commercial off the shelf (COTS) computerized systems for use in GLP and GCP environments using a GAMP4 and subsequently GAMP5 Risk based approach. Major systems include: o Oracle Clinical.

Successfully developed, implemented and managed a compliance program for the design and development of web-hosted software applications to track the collection, registration, annotation, storage, and distribution of donor samples and associated clinical and pathology report data in the Life Sciences industry meeting GxP requirements.Authored SOPs and.

Mclean, Virginia, US

• Interfaced with internal and external staff as well as contract companies to successfully develop and manage Quality programs for multi-million dollar pharmaceutical automation projects with major pharmaceutical.
• Managed various teams of Software Quality Assurance (SQA) test engineers and Quality Control (QC) engineers.
• Managed several client audits and associated follow-up activities. Several products validated and in use in regulated environments.
• Group Quality Assurance representative for a corporate effort to implement AS9100 and ISO9000 throughout the corporation and key contributor to the initial certification of the TALON® Robot.
• Corporate team “lead” responsible for interfacing with various group and corporate managers to author, train and maintain a corporate Design and Development Process.

• A medical device company. I worked for the COO and was responsible for transferring three product lines from facilities in Colorado to a start-up facility in Massachusetts.
• Assisted in selecting, setting-up and maintening a quality manufacturing ERP/MRP system for BOM, planning, purchasing, shipping and returns as well as the physical manufacturing floor.
• Assisted with the writing of quality documentation, SOPs, and assembly instructions on a stereo tactic radio surgery product line meeting Quality Systems Regulation (QSR) Requirements (Medical Device QSR or 21 CFR Part.

Contract position validating Hardware and Software Systems at Pfizer in Groton, CT.

• Foster-Miller, Inc., assisted in the design and development of User and Functional Requirements for several automated workstations for a large pharmaceutical project.
• Miscellaneous Y2K and Consent Decree project work in NJ, NC and PR.
• Held various contract positions performing various validation services for companies such as LMSi in Groton, CT.

• Responsible in conjunction with Waters Corporation in developing quality processes including a pharmaceutical Life-cycle process for the manufacture and delivery of automated equipment.
• Responsible for creating application qualifications for transferring manual methods to automated methods. Familiarization with Content Uniformity, Dissolution, HPLC, UV/VIS and associated reporting software packages.
• Field Service performing Installation (IQ), Operational (OQ), and Performance (PQ) Qualifications on pharmaceutical instrumentation.
• Managed the development of Operations Manuals, Qualification Documents and Service Manuals for automated Dissolution and Content Uniformity equipment.
• Training Administrator responsible for needs assessment, course development, and instruction. Managed global training courses and records.
• Domestic and International OEM Accounts Manager.

As, Engineering Technology

Certification Courses, Fire And Ems

Certificates, Misc. Qa And Validation Courses

Marketing Management And Business Administration