The posting
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 Director of QC Operations leads the QC Operations team and is accountable for day-to-day Quality Control execution across Vaxcyte contract manufacturing and contract testing network. The role ensures the current business has the QC support it needs, that testing and release happen on time, and that Quality Control operates in a compliant, inspection-ready state through VAX-31 BLA and into commercial supply.
As the executive function of Quality Control, the role provides leadership and oversight for implementation of the approved analytical control strategy and specifications at the contract manufacturing and contract testing organizations. Working closely with Analytical Development, Analytical Science and Technology, Stability, Quality Assurance, Regulatory Affairs, and the Analytical Technical Leads, this role is critical to timely, compliant, and uninterrupted release of Vaxcyte products.
Essential Functions:
- Day-to-Day QC Execution and Release
- Leads the QC Operations team and is accountable for sample flow, testing schedules, and turnaround commitments across the contract testing network.
- Provides leadership and oversight for implementation of the analytical control strategy and specifications at the contract manufacturing and contract testing organizations, as set through project team governance.
- Oversight on reviews and approval of vendor documents supporting execution, including sampling plans, change controls, and test methods.
- Ensures that QC operations deliver batch release through certificate of analysis generation and timely review and approval of analytical results.
- Ensures on-time testing and release so that manufacturing and supply commitments are met.
- Vendor Collaboration and Oversight
- Acts as the main Global Analytical contact for QC routine operation with contract manufacturing and contract testing organizations.
- Runs day-to-day operational oversight of external laboratories, including performance against agreed turnaround, quality, and compliance expectations.
- Strengthens vendor collaboration through dedicated and focused working sessions and escalates commercial and contractual matters to Global Analytics and Technical Operations.
- Quality Events, Investigations, and Data
- Takes ownership of cross-component quality incidents related to analytics, including deviations, laboratory investigations, and out-of-specification and out-of-trend results, driving them to root-cause-based closure with corrective and preventive actions.
- Ensures that QC Operations takes ownership or provide support on quality incidents related to analytics, including deviations, laboratory investigations, and out-of-specification and out-of-trend results, driving them to root-cause-based closure with corrective and preventive actions.
- Owns trending of analytical data related to release and escalates emerging risk to the Head of Quality Control and the relevant Analytical Technical Lead.
- Ensures data integrity principles are applied in all QC activities in compliance with Vaxcyte policies, guidelines, and procedures.
- Controlled Documentation and Compliance
- Authors and maintains the QC policies, standard operating procedures, work instructions, and templates that describe how QC operates today, and keeps them current as the process changes.
- Ensures QC activities comply with cGMP, global regulatory requirements, and internal standards.
- Implements the QC framework and governance developed for commercial readiness into routine QC practice.
- Audit and Inspection Support
- Supports regulatory inspections, pre-approval inspection readiness, and customer and partner audits with QC due diligence, documentation, and subject matter expertise.
- Ensures QC records, results, and investigations are complete, retrievable, and defensible.
- Team Leadership and Capability
- Takes ownership of QC operations training curricula and status of training.
- Leads, develops, and coaches the QC Operations team across sites and time zones, setting clear priorities and performance expectations.
- Plans QC Operations resources in alignment with manufacturing and testing schedules so that analytical deliverables and testing are carried out to quality standards.
- Builds a culture of accountability, learning, and collaboration, and partners with Quality Assurance as one quality unit.
Requirements:
- Bachelor of Science with 10+ years of relevant experience in the biotechnology or pharmaceutical industry.
- Direct leadership of a GMP quality control function, including line management of a QC team.
- Experience managing and overseeing contract laboratories and contract manufacturing organizations, including performance monitoring.
- Comprehensive knowledge of cGMPs and multi-national regulations.
- Demonstrated ownership of deviations, out-of-specification investigations, and corrective and preventive actions in a GMP laboratory setting.
- Experience supporting regulatory inspections and partner audits from a quality control standpoint.
- Experience authoring GMP controlled documents, including standard operating procedures, work instructions, and templates.
- Excellent communication, negotiation, and relationship-building skills, with the ability to collaborate effectively with internal and external stakeholders.
- Strong organizational, management, teamwork, and interpersonal skills, and professionalism required.
- Relentless focus and passion around process improvements, efficiency, and automation.
- Vaccine or conjugate vaccine experience preferred.
Reports to: Senior Director, Quality Control
Location: Visp, Switzerland
Work Arrangement (may be adjusted based on business needs, job responsibilities, or changes to company policy):
Hybrid (minimum of 3 days per week onsite)
Compensation:
The compensation package will be competitive and includes comprehensive benefits and an equity component.
Relocation:
This role is not eligible for relocation assistance.
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.
