Christina Schwalbe

About Christina Schwalbe

With broad cross-functional global cGxP expertise across Biotech/Pharma, I have extensive experience in Clinical, Biologics, Commercial Manufacturing, Small Molecules, and start-ups. I’m recognized as a strategic and motivational leader with a proven track record of delivering significant results in operations management, regulatory compliance, and manufacturing.Passionate about improving patient outcomes, I am committed to ensuring that the products we deliver help enhance patients’ quality of life. I’ve led cross-cultural sessions on Japanese-U.S. relations, focusing on regulatory expectations and strengthening collaboration with the Japanese Health Authority. As a QC leader, I oversee the entire testing process—from initiation to the issuance of Certificates of Analysis—ensuring timely, high-quality product delivery to patients. My leadership consistently drives success through impactful decision-making, fostering accountability, business growth, and strong stakeholder relationships.My Core Competencies are:Leadership | Operations Management | Communication | Quality Control | Quality Assurance | Process Improvement | Stakeholder Management | Risk ManagementWhen I am not in the office, I love traveling and food!

Experience

1. Qc Operations Lead (Contract Laboratory Organization)

   Genentech

   Feb 2025 — Present · Oceanside, CA, US

Education

• Whittier College

  Bachelor's degree, Biology/Biological Sciences, General

  1993 — 1997

Skills

• Microbiology
• Quality System
• V&V
• Process Improvement
• Manufacturing
• Technology Transfer
• Lean Manufacturing
• Cross-Functional Team Leadership
• Change Control
• Ion Chromatography
• Capa
• Quality Control
• Gmp
• Laboratory
• Testing
• Hplc
• Biopharmaceuticals
• Method Development
• 21 Cfr Part 11
• Biotechnology
• Standard Operating Procedure (Sop)
• Six Sigma
• Chemistry
• Gas Chromatography
• Management
• Validation
• U.s. Food and Drug Administration (Fda)
• Glp
• Pharmaceutical Industry
• Sop
• Fda