Associate Director, Quality Assurance, Validation at Exokeryx, Inc.

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:

• 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.

Essential Functions:

• Provide guidance and oversight of validation activities across all manufacturing and production processes within the organization.
• Drive validation/qualification strategy and ensure continuous improvement of validation practices across the organization.
• Ensure adherence to regulatory requirements by reviewing validation documentation and maintain compliance with relevant standards.
• Participate in the design of validation/qualification activities.
• Maintain Validation Master Plans, Project Validation/Qualification plans, risk assessments, protocols, and reports to GMP standards.
• Identify areas for improvement within validation activities, propose changes to optimize procedures and enhance efficiency.
• Identify potential risks associated with processes and products and collaborate with subject matter experts to implement mitigation strategies to minimize quality issues.
• Work closely with manufacturing, regulatory, and quality operations to address quality concerns.
• Stay updated on industry trends and regulatory changes to ensure compliance in validation processes.
• Participate in root cause analysis for validation deviations, developing corrective and preventative actions.
• Establish and revise quality assurance procedures and policies.
• Promote a quality mindset and quality excellence approach to all activities.

Requirements:

• BS or BA with 8 years relevant industry experience.
• Demonstrate in-depth knowledge of GMPs, FDA and EU requirements and ICH guidelines.
• Must have a strong understanding of quality assurance principles and validation methodologies.
• Possess technical knowledge of manufacturing processes and equipment.
• Excellent analytical and problem-solving skills to interpret data and identify root causes.
• Strong project management skills with the ability to manage multiple projects simultaneously.
• Knowledge and experience in Risk Management principles.
• Vaccine 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: Vice President, Quality Assurance

Location: San Carlos, CA

Compensation: The compensation package will be competitive and includes comprehensive benefits and an equity component.

Salary Range: $192,000 – $199,000 (SF Bay Area). Salary ranges for non-California locations may vary.

Vaxcyte, Inc.

825 Industrial Road, Suite 300

San Carlos, CA 94070

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.