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Senior Manager, Quality Assurance, Drug Product
San Carlos, California, United States
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 Senior Manager, Quality Assurance, Drug Product will play a critical role in ensuring the quality, safety, and compliance of commercial vaccine products. This leader will oversee QA activities related to manufacturing, batch disposition, deviations, and risk management, while actively participating in audits and continuous improvement initiatives. The ideal candidate brings extensive QA experience in the biotech or pharmaceutical industry, strong leadership skills, and the ability to partner effectively across functions to support a culture of quality.
Essential Functions:
- Provide Quality Assurance oversight of Contract Manufacturing Organizations.
- Represent QA at internal cross functional team meetings and at Joint Project Team meetings.
- Lead batch disposition activities such as review of executed batch records, environmental monitoring and quality control data.
- Review and approve documentation such as master batch records, deviations, risk assessments, change controls, and CAPAs.
- Lead deviation and product complaint investigations
- Drive resolution of quality performance issues with the contract manufacturer.
- Support validation activities.
- Identify opportunities to streamline QA processes and systems
- Champion initiatives to enhance quality culture and operational excellence across the organization.
- Interact with key stakeholder to develop solutions to complex issues.
- Participate in compliance audits as required (health authority and contract manufacturer)
- Promote a quality mindset and quality excellence approach to all activities.
- Mentor and coach QA staff to strengthen technical capabilities and regulatory compliance mindset.
Requirements:
- Bachelor’s degree in Chemistry, Biology, Pharmacy, Engineering, or a related field.
- Minimum of 8 years of experience in quality assurance, batch record review, manufacture, or quality systems management within the pharmaceutical, biotechnology, or life sciences industry. Other combinations of education and/or experience may be considered.
- Strong knowledge of cGMP, ICH guidelines, FDA/EMA regulations, and other international pharmaceutical quality standards.
- Knowledge and experience in Risk Management principles.
- Experience in both clinical and commercial parenteral drug product required.
- Strong Management and process improvement skills.
- Demonstrated experience managing batch record review, deviations and change management.
- Demonstrate experience in annual product reports
- Great organization skills and have an attention to details.
- In-depth understanding of aseptic manufacturing (biologics) operations.
- Ability to prioritize multiple assignments and changing priorities.
- Excellent problem-solving skills and the ability to manage complex investigations and root cause analyses.
- Strong written and verbal communication skills, with the ability to clearly present quality issues to cross-functional teams.
Reports to: Director, Quality Assurance, Drug Product
Location: Hybrid; San Carlos, CA
Compensation:
The compensation package will be competitive and includes comprehensive benefits and an equity component.
Salary Range: $166,000 – $193,000 (SF Bay Area). Salary ranges for non-California locations may vary.
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.
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