Jonathan P. Email & Phone Number

Philadelphia, Pa, Us

Princeton, Nj

Kyowa Kirin is a growing worldwide pharmaceutical and biotechnology company with headquarters in Japan. The Company’s mission is to design and conduct effective and regulatory compliant drug development and commercialization globally. This currently includes an outstanding R&D pipeline with active clinical trials in the USA, Europe and Asia. Kyowa has unique strengths in biotechnology and is advancing as a leader in the development of biologics and driven by strong drug discovery initiatives as well as effective research collaborations and product licensing. Areas of focused product development include oncology, nephrology, immunology/allergy and CNS. The Company’s novel approach to drug discovery is reflected in a commitment to excellence in research on therapeutic antibodies, small molecules and nucleic acid drugs as well as regenerative medicine. Global Head of Quality/Chief Quality Officer provides leadership and expertise in creating, implementing and managing comprehensive strategic and operational plans for all aspects of Quality. This entails development of policies/practices which foster a culture of continuous improvement and high standards of quality throughout the organization. Provides strong strategic direction for QA and each operating unit to ensure that QA performance targets are achieved and that all aspects of compliance are addressed on an ongoing basis. Establishes GxP Best Practices, manage the process of annual planning for QA throughout the Company so that each operating unit and each location/plant are strategically aligned with respect to QA performance targets. Achieves compliance with applicable regulatory requirements at internal plants, CMOs and CROs by ensuring necessary preparations are made for all inspections. Collaborate with R&D in designing quality systems and take steps to assure that all levels of management are well informed regarding both internal and external quality issues.

Exton, Pa

Shire's focus is on rare diseases, neuroscience, GI and ophthalmics. Products are segmented into biologics, small molecules, and therapeutic modes ranging from mammalian cell culture, bacterial fermentation, cell therapy, oral solids, gene therapy, and combination products using devices. During my tenure I have held various senior leadership roles in sponsoring key significant Quality/TechOps projects and/or supported/led: Contracting Manufacturing Center of Excellence, development and roll out of a global QMS, right-first-time and a focused contamination control initiative as well as a company wide visual particle remediation initiative.Key organizational responsibility is currently for Shire Quality Assurance with operations in various worldwide locations. Global Quality includes both oversight of internal and external operations, setting and executing the Quality strategy, QA technical support, filing and regulatory ownership for quality and technical aspects of a product. Primary contact with regulators on QA manufacturing, analytical, stability and various other topics surrounding compliance. Roles sits on various Leadership governance councils: OpU Leadership Team, External Mfg. Oversight, Shire Quality Leadership, Global Quality Council, and the Product Development Council for Clinical and Early Phase Products.

Exton, Pa / Lexington, Ma

Overall responsibility for Quality strategy, design, team building and implementation of an organization that internally and externally manufactures, dispositions and distributes biological, pharmaceutical and medical device products. Led the US QA internal plants and external CMOs; hired, coached, and motivated team members. Ensured all biological, pharmaceutical and device commercial (GMP) and clinical (GCP) operations met all US and International regulatory requirements.Ensured all plants and CMOs within our manufacturing network were inspection ready at all times

Wayne, Pa

Responsible for overall compliance of all small molecule and biological external suppliers (manufacturing, analytical, and distribution sites) globally to GMPs/GDPs and applicable regional regulations. Led the global external supply Quality team; hired, coached, and developed employees within group. Approved products (commercial and clinical) for distribution, product/processes changes, validation, and technical transfers related to manufacturing as well as the execution of Quality technical agreements and global affiliate management

Wayne, Pa

Ensured all global Quality systems supported the manufacture of small molecule and biological products globally, and were in compliance with GxP regulations including deviations, CAPAs, change control, training, document control, internal/external audits, computer system validation, compliance, customer complaints, metrics, stability, regulatory intelligence and APR/PQR. Led the global quality systems team; hired, coached, and developed employees within group. Sponsored/participated on multiple operational excellence events including the globalization of the CAPA, deviation, APR/PQR, recall, and customer complaint systems. Responsible for the oversight and maintenance of all global supply chain SOPs/standards and Quality Manual.

Collegeville, Pa

Wyeth/Pfizer - Responsible for overall compliance with applicable local and international regulatory requirements, guidances, and practices; supported Board of Health inspections throughout the Wyeth network. Collaborated with manufacturing, R&D, global safety and surveillance, and other stakeholders to ensure global quality systems including change control, document control, training, auditing, and computer validation within the pharmaceutical, biopharma, consumer, and nutritionals operating units were in compliance with cGMPs.

Malvern, Pa

Managed overall internal audit prg and led and/or participated in GxP audits and systems; identified and closed compliance gaps prepared, and coordinated all site Regulatory visits; functioned as primary table lead during all inspections/audits and ensured follow-up and closure of inspection reports; implemented 4 new quality systems including a policy/guideline and industry surveillance GAP assessment system; a GMP service provider oversight process; and a compliance index metrics system; managed activities related to QA Validation, ensuring validation of site equipment and systems/processes were in compliance with applicable regulations, policies, SOPs and guidelines.

Malvern, Pa

Coordinated all product releases from our API monoclonal antibody plant, microbial pilot and GMP cell bank facilities; oversaw review/approval of batch records, SOPs, test methods, quality agreements, change controls, tech. and regulatory docs. (e.g. APR, PQR, SMF), validation reports, deviations, customer complaints, CAPAs, and raw material evaluations; participated on GMP audits of mfg. and support areas.

Horsham, Pa

Approved deviations, change controls, SOPs, validation and audit reports, MBRs, CAPAs, customer complaint investigations, recall procedures, technical docs., APRs, stability reports, and spec. docs; performed GxP audits and provided support during PAIs; acted as corporate liaison with CMOs regarding quality related topics including devs., change control, SOPs, analytical test method transfers, process/equipment validations, recalls/NDA FAR/PDRs, quality/supply agreements, GDP, and technical transfer docs.; approved process/equipment validation docs. including IO/OQ/PQ, CIP/SIP cycles, mixing time, hold time, container closure integrity, cleaning val., filter compatibility, microbial retention, and lyo.

West Point, Pa

Oversaw the Biological operations department process; supervised team of production employees and hired/trained staff. Completed manufacturing and complaint investigations, reviewed batch records, change controls, and validation documents. Prepared budget for department and analyzed inefficiencies of departmental systems/procedures and corrected.

West Point, Pa

Supervised a team of Solid dosage manufacturing employees and ensured compliance with SOPs and cGMPs. Maximized departmental efficiency by motivating and training team; scheduled assignment of work, equipment, ordered production materials, and verified formula requirements; wrote manufacturing investigations and associated CAPAs.

West Point, Pa

Performed batch record, analytical testing reviews, and managed product control through MRP inventory systems. Developed and implemented quality systems for new products/formulations. Participated on various new product launch teams and ran weekly supply chain meetings; collaborated with validation, tech services, production planning, and regulatory to help resolve quality investigations and streamline product cycle times. Reviewed and approved IOQ documents and created/reviewed policies, departmental position statements, guidelines, SOPs, and training tools; supervised QA inspectors and managed 3,500+ statistical quality inspections.

Bs, Environmental Resource Management

Mba, Business Administration