Associate Director, Quality Control Operations, Global Analytics

Vaxcyte•San Carlos, CA

7h•$184,000 - $214,000

About The Position

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, 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: The Quality Control Operations function is an executive role within a matrixed global vaccine organization, responsible for the implementation of Vaxcyte analytical strategies at our CDMO’s and CRO’s. This role is the single point of contact for our CDMO’s and CRO’s to ensure they deliver the quality, accuracy, and compliance of testing and analytical services. Working closely with the analytical technical lead and other functions within Analytics, Process Development, Analytical and Manufacturing Science and Technology, Quality Assurance, Manufacturing, and Regulatory Affairs, this role provides leadership and oversight for implementation of analytical strategies at the CDMO / external lab supporting analytical readiness and deliverables. The role is accountable that testing and release at our CDMO & CRO is performed in a timely and compliant manner to ensure secure and uninterrupted supply of Vaxcyte’s innovative therapies.

Requirements

Bachelor of Science with 10+ years of relevant experience in the biotechnology/pharmaceutical industry specifically in Quality Control. Other combinations of education and/or experience may be considered.
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).
Experience with digital tools for data management, document review workflows.

Nice To Haves

Experience in Pneumococcal vaccines is a plus.

Responsibilities

Implement and maintain analytical strategies for process-related, release and stability testing 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.
Lead and 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 regulatory documents and inspections by Health Authorities.
Writing, review and approval of documents related to Quality Control to ensure compliance with applicable regulatory and industry standards.