Senior Manager, Quality Assurance — Vaxcyte
NewCHF 83'500 - 126'500
Vaxcyte · Visp (VS)
- Location
- Visp
- Contract
- full-time
- Posted
- 2 days ago
SalaryCHF 83'500 - 126'500
Role overview
Join our Mission to Protect Humankind!
Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and costly health consequences when left unchecked.
Working to eradicate or treat bacterial infections such as invasive pneumococcal disease, Group A Strep, and Shigella is just the beginning.
- Join our Mission to Protect Humankind!
- Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and costly health consequences when left unchecked.
Application process
- Develop, implement and maintain procedures and policies as they apply to Drug Substance intermediates and custom raw material manufacturing for the Vaxcyte quality organization as needed.
Company and context
- The Senior Manager, Quality Assurance will serve as the Quality Assurance lead for Drug Substance intermediates and custom raw material activities, ensuring all operations performed at Contract Manufacturing Organizations (CMOs) meet Vaxcyte’s quality standards and global regulatory requirements.
- This role acts as the primary QA representative across internal and external cross-functional teams, providing oversight of deviations, investigations, risk assessments, change controls, and CAPAs.
- The Senior Manager will conduct detailed reviews of batch records, disposition packages, and technology transfer documents, driving timely issue resolution with CMOs and escalating risks as needed.
- In addition, this position will develop and enhance QA procedures, support continuous improvement initiatives, and contribute subject-matter expertise on biologics manufacturing and Quality Systems.
- The ideal candidate brings deep GMP knowledge, strong communication and collaboration skills, and the ability to thrive in a fast-paced, matrixed environment while managing multiple priorities. Essential Functions:
- QA Manufacturing representative for Drug Substance intermediates and custom raw material at Vaxcyte.
- Represent QA at internal and external cross functional team meetings.
- Review and approve internal and external documentation for compliance such as deviations, risk assessments, change controls, and CAPAs.
- Responsible for thorough QA review of CMO executed batch records in compliance with current regulatory guidance and industry practices and follow up on CMO responses.
- Review disposition package of Drug Substance intermediates and custom raw materials per global applicable regulatory requirements and provide to management for release.
Additional details
- MODEL EXCELLENCE: The magnitude of our challenge requires our shared commitment to demonstrating integrity, accountability, equality and clarity across communications and decision making.
- The ideal candidate brings deep GMP knowledge, strong communication and collaboration skills, and the ability to thrive in a fast-paced, matrixed environment while managing multiple priorities. Essential Functions:
- Interact with key stakeholders to develop solutions to complex issues while promoting quality standards of excellence. Reports to: Director, Quality Assurance Location: Visp, Switzerland
- Work Arrangement: Hybrid (minimum of 3 days per week)
Notes and original content
- The ideal candidate brings deep GMP knowledge, strong communication and collaboration skills, and the ability to thrive in a fast-paced, matrixed environment while managing multiple priorities.
- Essential Functions:
- Interact with key stakeholders to develop solutions to complex issues while promoting quality standards of excellence.
- Requirements:
- Strong overall knowledge of biologics manufacturing processes and Quality Systems.
- Reports to: Director, Quality Assurance
- Location: Visp, Switzerland
- Compensation:
