Senior QA Manager - Biologics/CMO Oversight (Hybrid)

Vaxcyte, Inc; Schweiz; Hybrid; CHF 120.000 - 180.000; Vollzeit

Benefits dieser Stelle

Equity component

Comprehensive benefits

Zusammenfassung

Vaxcyte, Inc is seeking a Senior Manager, Quality Assurance to lead QA activities for Drug Substance intermediates and custom raw materials at CMOs, ensuring GMP and regulatory compliance. You will oversee deviations, investigations, risk assessments, change controls, and CAPAs, and review documentation for release.

The ideal candidate will have deep GMP knowledge, strong communication, and the ability to thrive in a fast-paced, matrixed environment while managing multiple priorities, with

Qualifikationen

• BS/BA with a minimum of 8 years of Quality Assurance experience.
• In-depth knowledge of GMPs, FDA/EMA regulations and ICH guidelines.
• Strong communication and collaboration skills with cross-functional teams.
• Ability to travel 10-15% domestically and internationally.

Aufgaben

• QA representative for Drug Substance intermediates and custom raw materials at Vaxcyte and CMOs.
• Review and approve deviations, risk assessments, change controls, and CAPAs.
• Review batch records and disposition packages to ensure regulatory compliance.
• Provide guidance on supplier manufacturing investigations and technology transfer documents.
• Drive resolution of quality performance issues with CMOs and escalate as needed.
• Develop, implement, and maintain QA procedures for Drug Substance intermediates and custom materials.
• Interact with stakeholders to develop solutions while promoting quality standards.

Kenntnisse

GMP knowledge

Regulatory knowledge

Cross-functional collaboration

Attention to detail

Communication skills

Ausbildung

BS or BA in a related field

Jobbeschreibung

Vaxcyte, Inc is seeking a Senior Manager, Quality Assurance to lead QA activities for Drug Substance intermediates and custom raw materials at CMOs, ensuring GMP and regulatory compliance. You will oversee deviations, investigations, risk assessments, change controls, and CAPAs, and review documentation for release.

The ideal candidate will have deep GMP knowledge, strong communication, and the ability to thrive in a fast-paced, matrixed environment while managing multiple priorities, with