Associate Director, Quality Control
vor 4 Wochen
**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, periodontitis and Shigella is just the beginning. Our path to success is clear and well-defined, and Vaxcyte is set up to go the distance.
**WHAT** we do is every bit as important as **HOW** we 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**:
As Vaxcyte’s products progress towards late stage and commercialization, Vaxcyte is initiating development of dedicated biologics manufacturing facilities. Working closely with Process Development, Quality, Operations, and Regulatory functions, this role will be responsible for management of CMC activities related to Quality Control in order to ensure timely, compliant, secure, and uninterrupted supply of Vaxcyte’s innovative therapies. As part of the Quality Control organization for Contract Development and Manufacturing Organizations (CDMOs), your responsibilities encompass ensuring that products and services meet quality standards and regulatory requirements throughout the development and manufacturing processes.
This position will report to the Head of Quality Control of Vaxcyte Switzerland.
**Essential Functions**:
- Implement, and maintain robust quality control systems that encompass sampling, testing, documentation, and release procedures for raw materials, intermediates, and finished products.
- Writing, review and approval of documents related to analytical testing to ensure compliance with applicable regulatory and industry standards. Review and approval of technical reports to support investigations and expiry/retest periods.
- Manage the development and validation of analytical methods used for testing products. Ensure that methods are scientifically sound, reproducible, and suitable for their intended use.
- Ensure that contracted QC laboratories are equipped with appropriate instrumentation and equipment, maintained according to regulatory requirements, and calibrated regularly to ensure accuracy and reliability of test results.
- In partnership with the contract laboratories, manage method validation and transfer activities between contract laboratories, ensuring the accuracy, reliability, and consistency of test methods and results across sites.
- Assure that appropriate systems for data management, including the secure storage, retrieval, and retention of QC data and documentation are in place. Ensure that all testing activities are well-documented and comply with Good Documentation Practices (GDP).
- Review and approval of analytical data, test reports, and certificates of analysis (CoAs) generated by contract laboratories to verify accuracy, completeness, and compliance with specifications for both release and stability testing.
- Investigate and address deviations, out-of-specification (OOS) results, laboratory incidents, and customer complaints related to contract laboratory testing, collaborating with contract laboratories and internal stakeholders to implement corrective and preventive actions (CAPAs).
- Manage stability programs, regarding program design, data analysis, trending and regulatory submissions. In partnership with the contract laboratories, ensure that stability data are timely available, accurate and reliable.
- Manage the qualification and maintenance of reference standards.
- Develop and implement performance metrics to monitor the health and status of QC method performance; develop and implement improvement where indicated by the data.
- Provide technical support for product related regulatory inspections.
- Deputy for Head of Quality Control.
**Requirements**:
- Bachelor of Science with 10+ years of relevant experience in biotechnology/pharmaceutical industry.
- Excellent project management skills and experience in managing contract laboratories.
- Direct experience with analytical method development, qualification, validation and transfer as well as product characterization and analytical comparability.
- Comprehensive knowledge in cGMP and experience in multi-national
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