Joseph Lambert, Pharm.D., BCSCP

Lead global corporate quality assurance strategy, governance, and oversight for a diversified portfolio including biosimilars, monoclonal antibodies, insulin analogs, GLP-1 therapies, complex injectables, oral solid dose generics, and active pharmaceutical ingredients (APIs) across a multinational development and manufacturing network. Responsibilities include: -Defining and executing enterprise quality strategy aligned with global regulatory expectations, including FDA, EMA, ICH, WHO, CDSCO, and other international authorities -Providing corporate-level oversight of the Quality Management System (QMS), including governance of deviations, CAPA, change control, audit programs, and inspection readiness frameworks across both biologics and small molecule operations -Ensuring sustained regulatory compliance and inspection preparedness across development, commercial manufacturing, and lifecycle management activities for both biologics and generic pharmaceutical products -Overseeing quality governance for external partners, including suppliers, contract manufacturing organizations (CMOs), and contract laboratories, including quality agreements and performance oversight -Partnering cross-functionally with Manufacturing, Regulatory Affairs, R&D, Pharmacovigilance, and Supply Chain to assess enterprise quality risks and support continuous improvement initiatives across a diverse product platform -Supporting global regulatory inspections and agency interactions, including preparation strategies, response oversight, and remediation planning across multiple regulatory jurisdictions -Advising executive leadership on quality risk, compliance posture, governance structures, and escalation of critical quality issues

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Lead global corporate quality assurance strategy, governance, and oversight for injectable biologics and complex parenteral products across a multinational manufacturing and development network. Responsibilities include: -Defining and executing enterprise quality strategy aligned with global regulatory expectations (FDA, EMA, ICH, WHO) -Providing corporate oversight of quality management systems, including deviations, CAPA, change control, audits, and inspection readiness -Ensuring regulatory compliance and inspection preparedness across development and commercial operations -Overseeing supplier, CMO, and contract laboratory quality and quality agreements -Partnering cross-functionally with Manufacturing, Regulatory Affairs, R&D, Pharmacovigilance, and Supply Chain to manage quality risk and drive continuous improvement -Supporting regulatory inspections and agency interactions, including preparation, response coordination, and remediation planning -Advising senior leadership on quality risk, governance, and escalation matters Serve as a corporate quality leader, focused on governance, decision-making rigor, and sustainable compliance, rather than day-to-day site operations.

Subject matter expert (SME) in FDA pharmaceutical compliance with extensive experience leading regulatory actions under 21 CFR Part 211 to ensure drug safety, efficacy, and supply chain integrity. Spearheaded development of over 30 Warning Letters, multiple Import Alerts, and Non-Compliance Letters, managing a high-impact caseload of CGMP enforcement actions focused on data integrity and global manufacturing oversight. Served as SME on inspections, enforcement strategy, and case development, coordinating FDA 483 responses and remediation plans with internal and external stakeholders. Led inter-office regulatory negotiations to resolve critical quality issues and drive sustainable manufacturing improvements. Directed inspection readiness and field coordination for pre-approval and for-cause inspections, supporting enforcement priorities and drug shortage mitigation. Issued regulatory communications impacting billions of dosage units across API and finished product facilities worldwide. Guided complex compliance strategies involving OOS investigations, inadequate lab controls, and systemic failures. Authored regulatory memoranda resulting in market removals, product recalls, and third-party oversight. Engaged cross-functionally with CDER, ORA, and FDA offices, contributed to policy development and training, and mentored compliance officers across teams. Served on high-level committees to address imminent public health risks and improve regulatory timeliness. Recognized for leading regulatory discretion actions that enabled life-saving drug access during shortages.

Seasoned FDA investigator and regulatory leader with extensive experience in pharmaceutical CGMP compliance, pre-approval inspections, data integrity investigations, PET (positron emission tomography) drug inspections, and post-marketing safety assessments. Held multiple roles within the FDA’s Kansas City District, including Drug Specialist, Lead Investigator, and Acting Supervisory Officer. Led nearly 200 onsite inspections across a diversity of commodities, including sterile manufacturing, APIs, PET drugs, biotechnology, pharmacy compounding, pharmacovigilance, and Bioresearch Monitoring (BIMO). Served as SME for complex enforcement cases and collaborated with CDER to assess manufacturing readiness and ensure regulatory compliance. Recognized with two U.S. Public Health Service (USPHS) Outstanding Service Medals for major enforcement actions involving adulterated levothyroxine products and unapproved supplements. Trained new investigators through the Generic Drug User Fee Act (GDUFA) program and was trained in the FDA's Level III Pharmaceutical Inspectorate training program. Spearheaded enforcement actions resulting in recalls, firm shutdowns, Warning Letters, and a signed Consent Decree. Served as primary reviewer for Drug Quality Reporting System (DQRS) submissions, Field Alerts and evaluated adverse events via MedWatch, identifying safety signals requiring inspectional follow-up. Provided operational oversight during supervisor absences and served as backup for the Pre-Approval Manager, ensuring continuity in FDA inspection and enforcement efforts.

As a Commander in the U.S. Public Health Service Commissioned Corps, served over 20 years in active duty with a focus on protecting and advancing national health and safety. Held leadership roles across pharmaceutical regulation, clinical care, emergency response, and regulatory enforcement, contributing to public health efforts as part of one of the nation's eight uniformed services.

As Chief Pharmacist & Health IT Lead at Indian Health Services, Haskell Health Center, led pharmacy operations for over 6,000 Alaska Native and American Indian patients with a $1,000,000 budget. Oversaw staff, implemented a pharmacy-based anticoagulation clinic, and directed major health IT initiatives including EHR configuration and Point of Sale deployment. Managed facility IT infrastructure, chaired the Pharmacy & Therapeutics Committee, and handled credentialing for 27 providers. Designed and built a new pharmacy space with integrated automation (ScriptPro), reducing medication errors. Also founded a pharmacy externship program with KU and Creighton, training 24 students.

As Assistant Chief Pharmacist at Indian Health Services, Winnebago Indian Hospital, managed outpatient pharmacy operations supporting over 100,000 annual visits and led a team of six staff members. Implemented and configured McKesson 2000 and Pyxis 2000 automation systems for both outpatient and inpatient dispensing. Improved pharmacy efficiency through workflow redesign and successfully coordinated the complete relocation to a new pharmacy facility.