Spencer Panter Email & Phone Number

Pearl River, New York, Us

Lead HQ GMP Quality Assurance function in support of internal and external manufacturing via the Quality Management System.• Manage Audit program and ensure continued compliance across GMP processes below as well as Training, Quality Technical Agreements (QTAs), Batch Record Review and Disposition and Annual Product Quality Reviews (APRs/APQRs).• Host and support successful health authority inspections across GxP areas.• Lead comprehensive process improvement project to ensure effective Product Complaint management for marketed and clinical programs to accommodate drug and combination (drug/device) products, and inform necessary pharmacovigilance (PV) and commercial activities and reporting.• Ensure Quality Systems are updated to ensure compliance with CFR, Medical Device (MDR) requirements, and ISO standards to accommodate new combination product and intended markets.• Manage quality and compliance risks, strategic staffing and ensure critical support in preparation successful product launches in U.S. and EU.

Pearl River, New York, Us

Pearl River, New York, Us

Support commercial and clinical product supply via management of Quality Systems and Contract Manufacturer (CMO) relationships emphasizing local governance, alignment with regulatory and ICH guidance, process improvement, and inspection readiness.• Led development and implementation of new Quality Manual policies and procedures in support of Compliance Enhancement Plans, including integration of legacy systems.• Served as process owner for Change Control, Deviations/Investigations, CAPA, Specifications Management, and other critical quality systems while providing guidance, training, operational support and workload planning for peers and direct reports.• Increased operational efficiencies by more than 30% in multiple system areas above by developing streamlined workflows, including re-designing departmental file structure and databases, all while improving compliance posture.• Chaired Quality Council and Quality Metrics/KPI program to enable pro-active diagnostic tools for problem solving, process improvement, and communication to senior leadership while automating and reducing the efficiency of reporting by more than 70%.• Established Quality Risk Management (QRM) program with impact across GxP areas, leveraging Clinical Study Management program principles and GMP Supplier Qualification Management to bolster Inspection Readiness and drive Quality Culture forward.• Led evaluation and implementation of new electronic Quality Management System (eQMS) across multiple sites, ensuring succesful project mangement and significant system savings.

Cranford, Nj, Us

Served as advisor to the Pharmaceutical and Biotechnology industry as a subject matter expert in the areas of manufacturing quality and compliance.• Developed offerings and solutions designed to ensure alignment with current and emerging regulatory requirements along with pro-active management of Quality systems and continuous improvement.• Enabled capabilities within manufacturing firms in areas of Quality Metrics, Analytics, and Risk Management while achieving significant business benefits, reducing quality costs, and positioning Quality as a competitive advantage.

Managed global documentation system and monitor performance metrics to ensure consistency and compliance posture relative to release and stability QC testing of pharmaceutical and biological products, intermediates, and raw materials throughout the cGMP supply chain.• Led harmonization effort required to integrate analytical testing documentation across ~ 80 manufacturing and testing sites, in addition to contracted manufacturing organizations (CMOs), eliminating redundancy and reducing compliance risk for the company’s largest commercial products.• Oversaw change control processes, managing 9 employees/contractors and ensuring continued compliance via alignment with registered requirements and on-time inspection/filing readiness.• Led 3 Merck Production System teams in utilizing six-sigma methodologies to improve the efficiency and effectiveness of production-critical documentation processes with anticipated productivity increases of 38% program-wide.

Kenilworth, Nj, Us

Managed quality control specifications for 12 FDA-regulated sites ensuring appropriate justification and alignment through the change management and centrally managed material inventory systems.• Supervised two staff specialists in addition to temporary colleagues.• Developed SIP-driven process to manage specifications, material resource codes and Official Chemical Names centrally for 68 global manufacturing sites, leveraging the efficiencies of new Global Change Management and LIMS systems.• Chaired Global Specifications Committee and author SOPs to ensure efficient multi-functional review of analytical change proposals from FDA-regulated sites and facilitate concurrence of content from all impacted stakeholders, ensuring consistency across the network.• Managed project to review and remediate specifications for 800 materials used in the U.S. market for compliance with Quality Systems Standards and alignment with compendia, product registrations (CMC), and across S-P sites in response to Consent Decree requirements, avoiding penalties of $15,000 per day.• Developed Best Practice addressing raw material variability (including FMEA assessment and risk-mitigation) in formulation development with R&D partners as part of S-P Quality by Design (QbD) Drug Product Team, creating a basis for next-generation scalable development and filings.

Kenilworth, Nj, Us

Represented Global Quality in the assurance of site compliance with statistical standards.• Developed quality standards/systems and provide guidance based on best practices developed through interpretation of ICH, FDA, and PhRMA sources.• Facilitated harmonization of sites by identifying regulatory and compliance gaps in statistically related procedures, including the evaluation of stability data and CMC support.• Conducted training in support of Worldwide Quality initiatives and provide subject matter expertise and group resource management in addressing company-wide Consent Decree commitments.• Conducted ad-hoc consultations related to technology transfer, engineering and sampling studies, six-sigma process capability evaluations, stability and expiration dating, and specification setting.

New York, New York, Us

Various roles within Pfizer Global Research and Development / Parke-Davis Manufacturing (div. Warner Lambert Co.).Positions of increasing responsibility in QC Analytical Chemistry Laboratories, Quality Engineering and Statistical Consulting, monitoring process controls and ensuring robustness, structuring research problems, recommending experimental design strategies, and applying appropriate data analysis methods to support production, formulation development and process optimization efforts.

Master Of Science (Ms), Applied Statistics

Master Of Business Administration (Mba), Pharmaceutical Marketing And Management - Industry Scholar

Bachelor Of Arts (Ba), Biology/Biological Sciences, General