Senior Manager, Quality Assurance

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 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. Our path to success is clear and well-defined, and Vaxcyte is set up to go the distance.

WHATwe do is every bit as important as HOWwe do it!Our work together is guided by four enduring core values:

*RETHINK CONVENTION: We bring creative and intellectual diversity to every facet of the work we do in order to innovate and re-innovate the way vaccines are delivered.

*AIM HIGH: We embody our collectively audacious goal to courageously make the most complex biologics ever attempted to protect humankind.

*LEAD WITH HEART: Everyone leads at Vaxcyte with a kindness-first, inclusive approach to collaboration and vigorous debate that advances our business objectives.

*MODEL EXCELLENCE: The magnitude of our challenge requires our shared commitment to demonstrating integrity, accountability, equality and clarity across communications and decision making.

Summary:

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.
• 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.
• Drive resolution of quality performance issues with contract manufacturers and proactively escalates issues to Vaxcyte management.
• Provide guidance on supplier manufacturing investigations.
• Support technology transfer activities and review of technology transfer documents.
• Participate in process improvement projects.
• Interact with key stakeholders to develop solutions to complex issues while promoting quality standards of excellence.

Requirements:

• BS or BA with a minimum of 8 years of Quality Assurance experience. Other combinations of education and/or experience may be considered.
• In-depth knowledge of GMPs, FDA/EMA regulations and ICH guidelines.
• Strong attention to detail.
• Knowledge in both clinical and commercial product desired.
• Excellent verbal, written, and interpersonal communication skills.
• Experience leading and contributing through influence and working in cross functional teams.
• Ability to work in a fast-paced team environment, and to consistently meet aggressive timelines while prioritizing tasks for multiple projects.
• Ability to adapt to changing priorities.
• Strong overall knowledge of biologics manufacturing processes and Quality Systems.
• Required experience with good documentation practices, technical writing, and cGMP standards.
• Ability to travel 10-15% domestic and international.

Reports to: Director, Quality Assurance

Work Arrangement:Hybrid (minimum of 3 days per week)

Compensation:

The compensation package will be competitive and includes comprehensive benefits and an equity component.

We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.