Matthew Mcmenamin Email & Phone Number

Hilltown, Pennsylvania, United States

Biopharmaceutical professional consulting and company support specializing in Compliance, Quality, Validation and Program/Project Management.

Boyertown, Pennsylvania, United States

Residential and Commercial floor care including hardwood, carpet and upholstery cleaning, vinyl floor cleaning and refinishing, tile and grout cleaning.

Upper Providence, Pennsylvania, United States

• Lead the simplification and standardization of validation disciplines across GSK. Disciplines include Commissioning & Qualification of production and laboratory systems, Process Validation, Computer Validation and.
• Ownership of the Validation QMS and GxP requirements of IT/Digital Management System, Global SOPs and shared validation templates and global ways of working.
• Developed central processes and procedures to allow forty plus sites to transition for… Show more
• Developed central processes and procedures to allow forty plus sites to transition for independent ways of working to a single way of working across Medicines, Vaccines and R&D business units.
• Enhancements made to ways of working led to 50% savings on validation activities (time and budget) with only a core set of global SOPs to maintain allowing for rapid update and audit response. Show less

Greater Philadelphia Area

• Head of Global Computer Validation for central IT systems and Business Quality Owner of Artwork & Packaging Services software.
• Led a team validating software for over 30 enterprise and pharmaceutical supply chain systems. Validation of systems for manufacturing, laboratories, and central quality such as LIMS, serialization, document.
• Development of Quality position for the introduction of innovative technologies (i.e., Cloud… Show more Head of Global Computer Validation for central IT systems and Business Quality Owner of Artwork & Packaging.
• Development of Quality position for the introduction of innovative technologies (i.e., Cloud Computing, Biometrics, Artificial Intelligence, Machine Learning). Quality lead of data disposition for mergers.

Upper Providence, PA

• Team Lead in Quality Standards for Validation, Change Control and Periodic Product Review (PPR). Working with manufacturing sites and the central technical to embed knowledge driven decisions to enhance product quality.
• Site audit remediation support including regulatory warning letters. Use of new process validation ways of working to increase process control of Critical Quality Attributes. GSK President’s Roll of Honor for audit.
• Developed and tiered-level community of practice encompassing all Medicines and Vaccines sites.
• Site support as requested for Product Lifecycle Management and Qualification/Validation.
• Lead respondent for GSK on draft regulatory guidance documents pertaining to validation.
• Owner of Validation QMS documents.

Upper Merion, PA

• Validation Manager for two independent biopharmaceutical manufacturing suites. Responsible for overall Validation Program including ten direct reports and consultants. Primary Validation point of contact for audits.
• Integrated Commissioning &… Show more Validation Manager for two independent biopharmaceutical manufacturing suites. Responsible for overall Validation Program including ten direct reports and consultants. Primary.
• Integrated Commissioning & Validation (ICV) for an internal biopharma product (~$120M capital project).
• ICV readiness to manufacture an external product (as a Contract Manufacturing Organization) (~$8.6M capital project).
• Completion of biopharma ICV project and preparation for European file.
• BioPharma shipping validation, shipping verification and onsite representative at CMO for FDA audit.

Greater Philadelphia Area