Drew Mateya

Director Of Quality at ECM Therapeutics, Inc.

Pittsburgh, PA

How does this work?

Experienced Senior Director of over 14 years with demonstrated history of working in biotechnology, medical device, pharmaceutical, and regenerative medicine industries. Hands-on leader that applies logical problem solving skills and critical thinking in a pragmatic and fine-tuned manner to any organization or situation. Specializing in start-ups, clinical trials, and commercial settings. Skilled in Business Operations and Quality Systems Management.

Ask me about
Quality Management Systems
Medical Device
Regenerative Medicine
ISO 13485
ISO 9001
Master Control
Blue Mountain Regulatory Asset Manager (BMRAM)
Work experience

Feb 2020 - Present

ECM Therapeutics, Inc.

Director Of Quality

• McGowan Institute for Regenerative Medicine (MIRM), Stephen Badylak Laboratory • Participate in processing of complaints, change notifications, internal audits, external audits, medical device/biologics manufacturing oversight. • Administrate Qualio QMS software. • Author, review and approve SOPs, protocols, reports, specifications and other quality and regulated records. • Oversee GMP Quality Management Systems, Batch Release and QC testing activities for compliance to internal procedures and FDA, EU, ICH, and other requirements. • Lead the technical transfer, verification and/or qualification of internal test methods to QC lab for release of raw materials, in-process materials, intermediates, starting materials and finished products. • Manage the implementation, qualification, validation and transfer product / device specific methods. • Assist in timely writing, editing and review of documents such as Standard Test Methods, Technical Reports and QC SOPs. • Work closely with Manufacturing team to ensure proper preparation and submission of comprehensive manufacturing documentation. • Oversee review and approval of analytical method validation reports for compliance to internal quality standards and regulatory guidance’s. • Lead and facilitate thorough GMP investigations for process deviations, out of specification test results, Out of Tolerance events and corrective actions. • Oversee batch review activities and disposition of medical device / biologics. • Oversee device / and product stability programs including generation of stability protocol, execution of stability testing, stability analysis and final reporting of stability data. • Review and provide quality input for CMC sections of IDEs, BLA, device applications, and IMPD submissions for drug substance, device, drug products and stability studies. • Failure analysis, problem solving, and risk assessment and mitigation activities related to the qualification and validation of the GMP facility and equipment

Jan 2012 - Present

Steel City NDT LLC

Director of Operations & Quality

• Owner / Founder • Responsible for managing and implementing company's change control, safety, deviation investigation, and Corrective and Preventive Action (CAPA) systems • Create, implement and revise quality protocols, test procedures, material and equipment specifications for use across multiple inspection methods • Ensure adherence to all applicable regulatory bodies for the purposes of testing and inspections as well as client requirements • Serve as project manager and coordinator among all active jobs to ensure timely completion. • Perform periodic performance reviews, create personnel development/training plans, supervise, mentor and assign work tasks for employees • Perform internal audits on existing systems and external audits against suppliers of equipment, materials and services • Perform company training on new or revised procedures and systems • Responsible for business operation tasks such as accounting, marketing, sales and advertising. Acted as SEO and liaison to a national search engine optimization firm • Responsible for all customer complaint handling and to implement continual improvement processes to ensure positive growth

Jul 2019 - Feb 2020

rose plastic medical packaging

Director Of Quality

• Creates, schedules and executes validation activities (IQ, OQ, PQ) to ensure compliance with regulations and company standards • Maintains validation policies, procedures and information in SAP • Conducts and defines internal audits and self-assessments according to defined guidelines of ISO 9001 and ISO 13485 • Provides technical and statistical expertise to Quality teams • Directs the Quality System audit/inspection & CAPA programs, ensuring timely & effective management • Maintains all aspects of the cleanrooms including system validation and ongoing environmental monitoring • Monitors and manages budget to ensure operating costs for department are within approved and expected fiscal parameter • Directs and oversees the Quality personnel through the supervision of quality control leads • Presents data, statistics, and measures relating to customer perception and quality control process effectiveness at planned, quarterly Management Review meetings. • Ensures products meet or exceed customer expectations (specifications) and that all product specifications are available for all finished products. Develop inspection and test results in SAP • Ensures all quality related testing is being performed on product and documented in SAP • Proactively reviews and improves quality systems and processes • Injection Molding • Blow Molding • Plastic Manufacturing


Oct 2017 - Jul 2019

Cook Medical

Calibration & Maintenance Supervisor

• Responsible for overseeing and managing company's calibration and maintenance program • Manage a team of maintenance and calibration technicians • Manage over 5,000 pieces of equipment within a computerized maintenance management software (CMMS) package to ensure all maintenance and calibration activities are current • Manage an electronic calibration software package (GAGEtrak) to ensure all documentation and records are up to date • Manage vendor files, communications, qualifications and external calibration services • Author, revise and maintain the Maintenance and Calibration documentation system to adhere to applicable medical standards as well as ISO 9001, 13485, 17025 standards • Draft and execute protocols for validation activities including equipment qualifications, cleaning, temperature mapping, process validation, etc • Write and review change controls, deviations and CAPAs to provide subject matter expertise to asses impact to validated systems and processes • Serve as calibration and facility SME during internal audits and regulatory audits, providing response plans for gaps an compliance related issues. • Provide metrics and progress reports to senior management on quality, calibration, facility and maintenance related projects • Perform periodic performance reviews, create personnel development/training plans, supervise, mentor and assign work tasks for employees • Manage workload of continuous improvement projects • Ethics & Compliance Representative


Apr 2008 - Oct 2017

Cook MyoSite

Equipment & Facility Manager

• Responsible for overseeing and managing company's Equipment and Calibration (Metrology) department. • Served as a member of the Internal Audit team • Utilize CMMS, Electronic change control and calibration management software packages • Provided technical and subject matter expertise in regards to quality • Support GMP process facilities and develop expertise across validations, quality systems, auditing and continual improvements • Lead capital projects to ensure forward growth • Responsible for quality system development, CAPA implementation, nonconformance writing and monitoring • Directly involved in the collaboration amongst all departments to ensure a productive and developing environment • Manage Equipment and Facility department in a biopharmaceutical, aseptic and business environment, enforce FDA (CFR 210-211), ISO (9001 & 17025), cGMP, OSHA, European, and other regulations • Monitor laboratory and facility equipment utilizing a validated remote monitoring system, maintain calibration and maintenance schedules for all necessary equipment through external vendors, frame out SOP’s, vendor negotiations, implement all the Quality Control and Assurance measures • Provide metrics and progress reports to senior management on quality, calibration, facility and maintenance related projects • Perform periodic performance reviews, create personnel development/training plans, supervise, mentor and assign work tasks for employees


Apr 2008 - Dec 2008

Cook MyoSite

Material Control Associate

• Responsible for implementing company's material control system. Worked with department manager to develop the material control department • Test and analyze incoming reagents and other applicable materials • Perform inventory audits in-house and maintained supplier relations • Prepared and reported department analytics and metrics to upper management • Initiate nonconformance's against rejected materials, quarantine & discard as necessary • Ship biologic product and execute required paperwork to ensure traceability and delivery

Oct 2007 - Apr 2008

Justifacts Credential Verifications, Inc

Verification Specialist

• Researching and contacting companies, institutions, and references to verify the credentials of individuals for employment purposes • Create and review and send final reports to clients • Manage and track a caseload of clients to ensure timely delivery of products


Dec 2006 - Oct 2007

TesTex Inc.

Field Service Engineer

• Actively participate in Client safety programs • Set up and utilize nondestructive testing equipment • ASNT SNT-TC-1A UT II (Ultrasonic), MT II (Magnetic Particle), PT II (Dye Penetrant), VT II (Visual) • Remote Field Electromagnetic Testing (RFET), Low Frequency Electromagnetic Testing (LFET), Eddy Current Inspection • Calibrate nondestructive testing equipment • Conduct NDT tests to ensure quality or detect discontinuities • Establish techniques for proper examination of objects under inspection, ensuring strict adherence to safety regulations • Apply testing criteria in accordance with applicable specifications or standards and evaluate results • Interpret test results • Organize and report test results • Complete and perform quality control / quality assurance measures on reports

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