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Drew Mateya

Director Of Quality at ECM Therapeutics, Inc.

Pittsburgh, PA

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About

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
Quality Management Systems
Medical Device
Pharmaceuticals
Regenerative Medicine
Biotechnology
Start-ups
ISO 13485
ISO 9001
Qualio
Master Control
SAP
GAGEtrak
Blue Mountain Regulatory Asset Manager (BMRAM)
Work experience
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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

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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

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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

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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

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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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