Joseph Lambert

About Joseph Lambert

Senior pharmaceutical quality and regulatory leader with over 16 years of FDA and industry experience, currently serving as Vice President, Corporate Quality Assurance with responsibility for global quality strategy, governance, and oversight across injectable biologics and complex parenteral products.My background includes extensive experience within the U.S. FDA, spanning quality inspections, CDER Office of Manufacturing Quality compliance oversight, investigations, Field Alert Reporting, Out-of-Specification (OOS) and consumer complaint investigations, and Quality Unit evaluation and management. I bring deep working knowledge of 21 CFR Part 211, ICH Q7/Q10, EU GMP expectations, Bioresearch Monitoring (clinical trial audits), and Pre-Approval Inspections, as well as oversight of outsourced manufacturing and supplier quality.In my current role, I focus on-Enterprise quality strategy and governance-Inspection readiness and regulatory risk management-Quality systems oversight (deviations, CAPA, change control, audits)-Global supplier, CMO, and site quality oversight-Cross-functional leadership across manufacturing, regulatory, and development organizationsI have led and supported FDA 483 responses, remediation efforts, and complex quality risk mitigation strategies, with an emphasis on decision-making rigor, escalation clarity, and sustainable compliance, rather than reactive inspection preparation.PharmD by training, with a strong interest in technology-enabled quality systems, data-driven risk management, and modernizing quality organizations to improve both compliance and operational effectiveness.

Experience

1. Vice President of Corporate Quality Assurance

   Biocon Biologics

   Sep 2025 — Present · NE, US

   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 mattersServe as a corporate quality leader, focused on governance, decision-making rigor, and sustainable compliance, rather than day-to-day site operations.

Education

• University of Nebraska Medical Center

  Doctor of Pharmacy (PharmD), Pharmacy

  1999 — 2003

• University of Nebraska at Kearney

  Pre-Pharmacy