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Sr. Director, Quality Assurance and Compliance
Vaxcyte, Inc.
2024-09-21 09:37:58
San Carlos,
California,
United States
Job type: fulltime
Job industry: Executive Positions
Job description
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:
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.
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.
MODEL EXCELLENCE: The magnitude of our challenge requires our shared commitment to demonstrating integrity, accountability, equality and clarity across communications and decision making.
Summary:
Join Vaxcyte as a Quality Assurance Leader, where you will play a pivotal role in ensuring our continuous inspection readiness and regulatory compliance. This position entails managing and executing a risk-based vendor management program, overseeing the qualification and audit processes for contract service providers, and establishing company processes to identify and manage compliance risks. You will lead and support staff during inspections and audits, maintain strong relationships with internal and external stakeholders, and promote a quality mindset throughout the organization.
Essential Functions:
- Manage the implementation, execution, and maintenance of Vaxcyte's inspection readiness program.
- Responsible for the execution and maintenance of a risk-based vendor management program.
- Oversee the qualification and audit process for contract service providers and ensure controls such as quality assurance agreements are in place.
- Maintain strong relationships with internal and external stakeholders.
- Establish company processes to identify and manage compliance risks, mitigate and appropriately escalate issues in a timely manner.
- Monitor current regulatory requirements and assess the potential impact to the organization.
- Responsible for developing, trending and reporting compliance metrics.
- Assist in resolution of quality performance issues with vendors.
- Lead and support staff during various inspection and audit activities, will be the main contact during internal and external audits and inspections.
- Identify and implement corrective and preventative actions.
- Establish and revise quality assurance procedures and policies.
- Lead and support process improvement initiatives.
- Lead and facilitate Quality Management Reviews.
- Oversee the quality risk management process and site risk register as applicable.
- Ensure adherence to Vaxcyte policies and procedures.
- Ensure continuous inspection readiness and compliance with regulatory requirements.
- Promote a quality mindset and quality excellence approach to all activities.
Requirements:
- BS or BA with 12 years relevant industry experience.
- Demonstrate in-depth knowledge of GMPs, FDA and EU requirements and ICH guidelines.
- Experience with regulatory authority inspections.
- Skilled auditor.
- Knowledge and experience in Risk Management principles.
- Knowledge in both clinical and commercial product desired.
- Combination Device Product experience desired.
- Strong Management and process improvement skills.
- Demonstrate a high level of independent quality judgment.
- Demonstrate excellent verbal, written, and interpersonal communication skills.
- Demonstrate experience leading and contributing through influence and working in cross functional teams
- Strong sense of ownership in areas of responsibility.
Reports to: VP, Quality Assurance
Location: San Carlos, CA
Compensation:
The compensation package will be competitive and includes comprehensive benefits and an equity component.
Salary Range: $254,000 - $281,000