GMP Lab Compliance Lead (QA & Labs)

Vaxcyte; San Carlos (CA); Hybrid; USD 153.000 - 178.000; Vollzeit

Zusammenfassung

Vaxcyte in San Carlos, CA is seeking a hands-on Lab Compliance Manager to join our Global Analytical organization. You will serve as the primary compliance partner for the AD laboratories, working with QA to implement quality policies and GMP readiness in a lab setting.

The role requires transitioning the AD labs to GMP-compliant operations, managing the Sample Management Specialist, and ensuring documentation, training, and inspection readiness to support Phase I/II programs.

Qualifikationen

• Bachelor's degree in life sciences or related field, or equivalent experience.
• 8+ years in compliance, quality, analytical, or lab roles in biopharma.
• GMP/GLP knowledge and lab procedures.
• Experience authoring controlled documents (SOPs, protocols).
• Data integrity (ALCOA+) and GDP familiarity.
• Experience with equipment qualification activities.
• Strong collaboration and communication with QA and scientists.

Aufgaben

• Directly manage the Sample Management Specialist and ensure GDP-compliant handling.
• Translate QA policies into AD lab SOPs and forms.
• Support change control, deviations, OOS/OOT, and CAPA as per QA.
• Implement ALCOA+ data integrity across paper and electronic records.
• Oversee IQ/OQ/PQ for AD instruments and calibration.
• Maintain equipment logs and qualification records for inspection readiness.
• Coordinate training and maintain training records for lab staff.
• Serve as lab contact for QA during audits and inspections.

Kenntnisse

GMP/GLP knowledge

SOPs authoring

ALCOA+ data integrity

GDP practices

Equipment qualification

Cross-functional collaboration

Training & mentoring

Inspection readiness

Ausbildung

Life sciences degree

Tools

Benchling

LIMS

Jobbeschreibung

Vaxcyte in San Carlos, CA is seeking a hands-on Lab Compliance Manager to join our Global Analytical organization. You will serve as the primary compliance partner for the AD laboratories, working with QA to implement quality policies and GMP readiness in a lab setting.

The role requires transitioning the AD labs to GMP-compliant operations, managing the Sample Management Specialist, and ensuring documentation, training, and inspection readiness to support Phase I/II programs.