John Kovach Email & Phone Number

Louisville, Ky, Us

Irving, Texas, Us

• The Quality Audit Manager coordinates and develops internal audit processes, including developing internal audit plans and audit schedules.• Audits operational and quality processes for compliance with applicable regulatory and client requirements as per the internal audit plans and schedules. • Manages external audits to ensure that the company is in compliance with client requirements and in compliance with FDA regulations for all services provided. This also includes ISO9001:2015, National and State Boards of Pharmacy, and Drug Distributor Accreditation (DAA) formerly known as VAWD certification. • Collaborates with applicable department leaders to develop corrective actions and responses to audit findings from internal and external audits.• Submits responses to external auditors using the prescribed response method defined by the auditor or internal procedure.• Performs periodic process audits to ensure correct packaging was utilized for outbound shipments, as well audits of packaging components to ensure proper storage was maintained.• Prepares and presents quality audit reports to senior leadership to support management review activities.

• Conduct impact assessments and investigations on deviations and OOS/OOT issues related to Chimeric Antigen Receptor T-Cell (CAR-T) manufacturing and quality operations. • Use the TrackWise® deviation event tracking system (ETS) to investigate, document and approve non-conformances from manufacturing specifications and procedures. • CAR-T Cells are being used to fight Multiple Myeloma plasma cell cancer. Ciltacabtagene autoleucel (Carvykti™) the CAR T-cell therapy product name. Each dose is customized using the donor/recipient patient's own T-cells, which are collected, genetically modified, multiplied, and infused back into the patient.

Troy, Mi, Us

• Support the evaluation of non-conformance investigations and root cause analysis through the Quality Assurance review of records of investigations and reports. • Support the effective and compliant execution of COVID-19 Vaccine tech transfer activities and development of necessary quality systems at the External Manufacturing (EM) sites and associated off-site storage locations.• Perform review and approval of equipment and facility qualification, technical documents, raw material specifications, analytical methods, and master batch records to ensure Company products/processes comply with cGMP requirements.• Support regulatory submission activities, and lead inspection readiness activities in partnership with EM site and JJRC to support global health authority approvals.• Following successful tech transfer, support quality oversight for day-to-day production activities, including deviation and CAPA management, escalation of critical issues, and change control.• Monitor EM quality performance and proactively identify risks and mitigation plans through benchmarking and knowledge sharing.• Influence and build relationship with internal and external partners to continuously enhance quality culture and business excellence.• Interface with other functions (Operations, Planning, Technical Operations, Local Affiliates etc.) to meet patient supply requirements• Apply cGMP regulations and other FDA and international regulatory requirements to all aspects of the position.

Waltham, Massachusetts, Us

Responsible for external and internal audit programs that ensured compliance with regulatory requirements, including that CMOs and service providers consistently meet FDA and EMA regulations for the manufacture, testing, packaging, and distribution of approved drug products. • Conduct risk based GMP audits of external CMO/CRO partners and internal GXP departments. Assure compliance (internally and externally) with 21 CFR 210/211, 11, 312, EudraLex Vol. 4 & annexes, ICH, and other applicable regulations & regulatory guidance. • Write, implement, and improve Quality System, SOPs, policies, and procedures to be consistent with corporate objectives and current regulatory guidance.

Rockville, Maryland, Us

• Responsible for management of the Document Management group which manages Standard Operating Procedures (SOPs), the Learning Management System, and all GMP documentation, both paper and electronic. Veeva Vault Docs & QMS being validated. • Responsible for Quality oversight of software validation, and implementation and validation of Quality Management System (QMS) tools such as Veeva Vault and QMS tools for SOPs, training, change, deviation, CAPA, audits and supplier management. • Review and Quality approval of internal & external deviations, product quality complaints, change control requests, annual product quality reviews (APQR), stability data and reports. • Responsible for performing internal and external supplier audits through on-site and remote auditing methods.

Louisville, Kentucky, Us

• Quality Compliance Manager for US WorldMeds, LLC responsible for supplier quality management (SQM) and auditing of suppliers and contract manufacturers of US WorldMeds biopharmaceutical drug products. • Responsible for providing Quality unit leadership, oversight and guidance both internally and to external partners.• Responsible for QA oversight functions including: compliance auditing (supplier & contract manufacturer audits, and internal GMP auditing); batch record review & product release; stability program monitoring; complaint & adverse event management & reporting; management of internal quality systems (i.e., deviation management, CAPA, change control, document control & training); and coordination, monitoring & hosting of regulatory inspections. • Serves as the Quality Assurance Representative on project teams for drug products in development, technical transfer, commercial production and being considered for acquisition. Work with the project teams, contract manufacturing partners and suppliers to develop and maintain Quality Agreements to govern manufacturing operations and supply services.

Oxford International Regulatory & Compliance Services, Madison, Wisconsin • Compliance Auditor and Quality Consultant on a consent decree remediation and certification project for the McNeil Consumer Products division of Johnson & Johnson in Fort Washington, PA. Feb 2014 to Nov 2014. SQA Services, Inc., Rolling Hills, California • QA Auditor conducting GMP compliance audits at supplier firms on behalf of pharmaceutical and medical device manufacturing firms. Clients included: Teva, Amerigen, DePuy (J&J) and Valeant Pharmaceuticals. Audit sites included: Sterigenics, Mylan Laboratories, PakLab and DDN/Obergfel Distribution Center. Oct 2013 to Feb 2014.Oso Biopharmaceuticals Manufacturing, LLC, Albuquerque, New Mexico • QA Consultant at Oso Bio, a parenteral drug filling contract manufacturer in Albuquerque, NM. Contracted to update quality systems and documentation for Validation and Compliance. Apr 2013 to Aug 2013ProPharma Group, Overland Park, Kansas • Provided Quality Assurance oversight of a product transfer project with 40+ animal health products being transferred into Bayer HealthCare’s contract manufacturing facility in Shawnee, KS. Product technologies being transferred include: sterile injectables, solid oral dosages, powders, non-sterile liquids and suspensions. Responsible for review and approval of Master Batch Records, raw material & packaging Specifications, Laboratory Methods, Validation Protocols, Summary Reports, and Stability Studies. Apr 2012 to Apr 2013. • Sr. QA Representative for the clients of Lonza Biologics, Hopkinton, MA for multiple API product transfer and process validation campaigns for the manufacture of biological drug products to be used for clinical trials and commercial product launches. Aug 2011 to Apr 2012. • GMP Compliance Auditor assigned to perform a 5-day FDA mock inspection of the Novartis Animal Health headquarters in Greensboro, NC. July 2011.

Verona, Vr, It

• Performed regulatory compliance auditing of Aptuit CMO and CRO sites; provided consulting on Quality Systems development; authored Global Quality Standards; and supported Aptuit site regulatory inspections.

Indianapolis, Indiana, Us

• Developed and implemented global quality systems that govern GMP activity across Lilly's diverse global manufacturing operations to promote consistent quality processes. Served as an author and subject matter expert on Global Quality Standards. • Provided quality assurance consulting to manufacturing and quality operations on interpretation and implementation of Lilly global quality systems. • Coordinated and conducted annual Management Reviews of the corporate Quality System.• Developed quality training courses on contract manufacturing, technical writing for change controls and deviation reports.

• Quality Assurance Engineer role was created when the Schein facility was placed under Consent Decree by the FDA in 1998. The purpose of the role was to support the remediation and Corrective Action Plan for the facility to return to a state of full GMP compliance. Quality Engineering role oversaw, from a quality perspective, the significant amount of equipment re-qualification, process re-validation and CAPA activity required to re-launch the medically necessary products under the terms of the Consent Decree. • Responsible for the quality and technical support of quality assurance, engineering and validation for large scale parenteral generic drug manufacturing operations running in six aseptic manufacturing suites. • Developed and managed the Change Control system by performing review and approval of change requests along with providing technical support on change control development.

• Responsible for leading a team of validation specialists and contractors in the development of qualification and validation protocols, execution of studies and preparation of summary reports on critical utilities, aseptic drug processing equipment and clean room facilities. A key element of the role was to conduct Process Validation for legacy injectable products.

Responsible for Validation Department management and provision of contract validation services for biopharmaceutical customers; projects at Bayer and Ligand Pharmaceuticals, Inc. Responsibilities include managing teams of validation engineers and specialists in the development and execution of equipment qualification (IQ, OQ & PQ) and validation studies.

Managed validation and regulatory consulting projects for biopharmaceutical clients; assignments included: Ortho Biologics, Amgen, Inc., Centocor, Miles, Inc. (Bayer), Warner-Lambert, ConvaTec/Bristol-Myers Squibb, Inc., Dumex Ltd., Alcon Laboratories, Inc., and Eli Lilly and Company. Served as the Project Manager for a Consent Decree remediation consulting engagement with the Warner-Lambert company to re-certify GMP manufacturing operations at four W-L sites (Lititz, PA, Morris Plains, NJ and 2 sites in Puerto Rico).

Responsible for validating, certifying and maintaining the utility and process systems in the GMP pilot plant utilized to manufacture clinical biopharmaceutical products such as monoclonal antibodies, interferon and parenteral bio-response modifiers. Responsible for the validation and certification of a bio-safety level 3 facility used for the production of AIDS virus used for diagnostic test kits. Responsibilities of the GMP Auditor position involved GMP auditing, batch record review & release, raw material release, instrument calibration tracking, document control and procedure development.Meloy Laboratories was a biotechnology Contract Research Organization that developed biological products and performed research for NIH and parent companies (Revlon Health Care, then later Rorer).

Bachelor Of Science, Biology

Coursework In Biology/Biological Sciences (Transferred To Iup)