Sr. Manager, Quality Control

Vor 5 Tagen

Visp, Schweiz Vaxcyte Vollzeit

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:

  1. 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.
  2. AIM HIGH: We embody our collectively audacious goal to courageously make the most complex biologics ever attempted to protect humankind.
  3. LEAD WITH HEART: Everyone leads at Vaxcyte with a kindness-first, inclusive approach to collaboration and vigorous debate that advances our business objectives.
  4. 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 coordination and management of CMC activities related to Quality Control 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.

Essential Functions:

  • Create and implement QC strategies aligned with the CDMO's goals and objectives, ensuring they comply with relevant regulations and industry standards.
  • Implement, and maintain robust quality control systems that encompass sampling, testing, documentation, and release procedures for raw materials, intermediates, and finished products.
  • 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, oversee method validation and transfer activities between contract laboratories.
  • 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.
  • Support investigations and 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. Support definition of expiry/retest periods.
  • Oversee the qualification and maintenance of reference standards.
  • Provide technical support for product-related regulatory inspections.
  • 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 the biotechnology/pharmaceutical industry.
  • Excellent project management skills and experience in managing 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 management, teamwork, interpersonal skills, and professionalism required.
  • Relentless focus and passion around process improvements (efficiency and automation).

Reports to: Head of Quality Control of Vaxcyte Switzerland

Location: Visp, Switzerland

Compensation:

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

Vaxcyte Switzerland GmbH

Rottenstrasse 5

3930 Visp, Valais

Switzerland

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.

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