Steve Lubeck

Executive Director, Quality Compliance @ Exelixis

About

Experienced Quality Assurance professional with a demonstrated history of working in the pharmaceuticals industry. Skilled in Biotechnology, Validation/Qualification, Auditing, Vendor Management, U.S. Food and Drug Administration (FDA) inspection, ISO and GMP.

Country

United States

City

Pleasant Hill

Industry

Biotechnology

Skill

Quality Operations, Quality Auditing, Regulatory Filings, ICH, Biologics, International Logistics, Product Quality, Project Management, Quality Management, Pharmaceuticals, Vendor Management, Internal Audits, Good Manufacturing Practice (GMP), Small Molecules, Continuous Improvement, International Regulations, CAPA, 21 CFR Part 11, GMP, Validation

Experience

Executive Director, Quality Compliance

Exelixis

2021-11 - Present · 4 yrs 11 mos

Alameda County, CA

For Quality Compliance, I am responsible for the following: Supplier Quality Internal Audits External Audits Inspection Management Quality Agreement Performed vendor audits.

Executive Director, GCP/GVP QA

Exelixis

2025-10 - 2026-6 · 9 mos

Alameda, CA

Head of Quality Operations

Lonza

2020-4 - 2021-11 · 1 yr 8 mos

Hayward, California, United States

For Quality Operations, I was responsible for the following: Supplier Quality Raw Material Quality Shop Floor Quality (Upstream and Downstream clinical processes) External Quality Batch Record Review Product Disposition Document Control

Director, Quality Assurance Operations

Grifols USA, LLC

2017-7 - 2020-1 · 2 yrs 7 mos

Emeryville, ca

For Quality Assurance Operations, I was responsible for the following: Complaint Management for North America Clinical Diagnostic products Supplier Quality Management OEM/Vendor Quality Management Deviation/Non conformance/CAPA Management Change Control Management Auditing Role for third party distributors, suppliers and warehouses Commercial Quality for Procleix Blood Testing Product lines which includes Reagents and Instruments. Health Authority Inspection Support Customer Audit Support Management of a Global team Site Emergency Response team

Director, QA

Grifols

2014-6 - 2017-7 · 3 yrs 2 mos

Emeryville, Ca

For the Immuno Manufacturing and Partner Products, I was responsible for the following: Shop Floor Quality (Upstream, Downstream, Bulk Filling) Change Management Deviation/CAPA Management Customer Complaints Development Projects QA Validation Health Authority Inspections (FDA & ISO)

Director, QA Alliance Products

Novartis

2011-12 - 2014-6 · 2 yrs 7 mos

Emeryville, Ca

For the Alliance Products, I was responsible for the following: Global Product Release Change Management Deviation/CAPA Management Customer Complaints Development Projects Health Authority Inspections (FDA & ISO)

Associate Director, OEM/External QA

Novartis

2011-2 - 2011-12 · 11 mos

Emeryville. Ca

Responsible for the following: Global Product Release for Distribution Change Management Deviation/CAPA Management Health Authority Inspections (FDA & ISO)

Associate Director, Validation

Novartis

2005-4 - 2011-2 · 5 yrs 11 mos

Emeryville, ca

Responsible for the SIte Validation program in the following areas: Cleaning Equipment, Facilities, Utilities Methods Process Computer Systems Global Validation site representative Managed 14 FTEs and Contractors Health Authority Inspections (FDA & ISO)