Overview
Join to apply for the Senior Manager, Quality Control role at Vaxcyte.
Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from bacterial diseases. Our work includes tackling invasive pneumococcal disease, Group A Strep, and Shigella, with a clear path to success and long-term commitment.
Essential Functions
* Implement the analytical control strategy for our programs at our CDMO/contract labs and ensure alignment with the CDMO’s goals while complying with relevant regulations and industry standards.
* Implement, and maintain robust quality control systems that encompass sampling, testing, documentation, and release procedures.
* Ensure on-time performance for QC testing at our CDMO’s or contract laboratories related to raw materials, intermediates, and drug substance.
* Ensure contracted QC laboratories are equipped with appropriate instrumentation, maintained per regulatory requirements, and calibrated regularly to ensure accuracy and reliability of test results.
* In partnership with the analytical technical lead and analytical scientists, oversee method validation and transfer activities between contract laboratories.
* Assure that appropriate systems for data management, including secure storage, retrieval, and retention of QC data and documentation, are in place and that all testing activities 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 release and stability testing.
* Support investigations and deviations, out-of-specification (OOS), out-of-trend (OOT), and out-of-expectation (OOE) results, laboratory incidents, and customer complaints related to contract laboratory testing, collaborating with contract laboratories and internal stakeholders to implement CAPAs.
* Provide technical support for product-related inspections by Health Authorities.
* Writing, review, and approval of documents related to Quality Control to ensure compliance with applicable regulatory and industry standards.
Requirements
* Bachelor of Science with 8+ years of relevant experience in biotechnology/pharmaceutical industry.
* Experience in Pneumococcal vaccines is a plus.
* Excellent experience in managing CDMOs and/or contract laboratories.
* Comprehensive knowledge in cGMP and experience in multi-national regulations.
* Excellent communication, negotiation, and relationship-building skills, with the ability to collaborate effectively with internal and external stakeholders.
* Strong analytical and problem-solving abilities, with a focus on data-driven decision-making and continuous improvement.
* Strong teamwork and interpersonal skills.
* Relentless focus and passion around process improvements (efficiency and automation).
Reports to: Head of Quality Control
Location: Visp, Switzerland
Compensation: The compensation package will be competitive and includes an equity component.
Relocation: This role is not eligible for relocation assistance.
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.
Seniority level
* Mid-Senior level
Employment type
* Full-time
Job function
* Quality Assurance
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