Senior Manager, Quality Control Operations, Global Analytics — Vaxcyte
- Location
- Visp
- Contract
- Full-time
- Posted
- 30 days ago
Full description
Join our Mission to Protect Humankind!
Summary:
As Vaxcyte’s products progress towards late stage and commercialization, we are looking for people with experience in Quality Control for late stage or commercial products to strengthen our global Quality Control team.
Within that Quality Control Organization, we are seeking a Senior Manager Quality Control acting as single point of contact for our CDMO in Europe. The Senior Manager QC will represent the executive function of QC ensuring analytical strategies are implemented at our CDMO and/or external testing lab to ensure the quality, accuracy, and compliance of testing and analytical services. Working closely with the analytical technical lead and other functions within Analytics, Process Development, Quality Assurance, Operations, and Regulatory functions, this role is accountable that testing and release is performed at our CDMO in a timely and compliant manner to ensure secure and uninterrupted supply of Vaxcyte’s innovative therapies.
Essential Functions:
- Implement the analytical control strategy for our programs at our CDMO/contract labs and ensure they are aligned with the CDMO's goals and objectives as well as comply 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 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 analytical technical lead and analytical science and technology as well as the contract laboratories, 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. 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), out-of-trend (OOT), out-of-expectation (OOE) 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).
- 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 minimum 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).
Equal Opportunity
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.
Recruitment Fraud Notice
Please be aware of fraud or scams from individuals, organizations and/or internet sites claiming to represent Vaxcyte in recruitment activities. Vaxcyte has an established recruitment process for all positions prior to issuing an offer for employment and we will never extend unsolicited employment offers or ask candidates to provide financial or sensitive personal information as part of the application process. All legitimate communication from Vaxcyte will come from an official @vaxcyte.com email address. Qualified and interested candidates should apply to current openings at vaxcyte.com/careers.
Questions about this listing
What salary does Vaxcyte offer for this role?
The original listing does not state a salary. Our estimate for this role and sector in Visp is CHF 120'000 - 162'000 gross per year — an estimate, not a figure communicated by Vaxcyte. The calculator on this site converts a gross salary into your actual net take-home once cross-border tax and social contributions are applied.
Is this a full-time role, and what type of contract does Vaxcyte offer?
This listing is a full-time position. The contract type shown here comes directly from the employer's original posting; always confirm exact hours, notice period and probation length with Vaxcyte during the application process, since these details can vary by role even within the same contract category.
Do I need a cross-border work permit for a role in Valais?
EU/EFTA citizens living in an EU/EFTA state can apply for a G permit and can work anywhere in Switzerland: border zones no longer apply to them, and they must return home at least once a week. The Swiss employer files the request with Canton Valais's migration office after the contract is signed. Processing times vary by canton, so confirm the specifics with Valais's cantonal migration office or with HR during the application.
How do I apply for this position at Vaxcyte?
Use the "Apply now" button on this page — it links directly to Vaxcyte's original listing at boards.greenhouse.io, so your application goes straight to the employer's own applicant-tracking system. Frontaliere Ticino does not collect or forward applications itself.
