Senior Manager, Quality Assurance, External Manufacturing presso Vaxcyte

Summary:

The Sr. Manager, Quality Assurance, External Manufacturing will play a critical role in ensuring the highest standards of product quality and compliance across contract manufacturing operations. This position provides QA oversight of Contract Manufacturing Organizations (CMOs), leads batch disposition and documentation review, and represents QA on cross-functional and joint project teams. The ideal candidate is an experienced quality professional with a strong understanding of cGMP and global regulatory standards, capable of driving continuous improvement and fostering a culture of quality excellence across all manufacturing activities.

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.
• Drive resolution of quality performance issues with the contract manufacturer.
• Support validation activities.
• Develop, implement and maintain procedures and policies.
• Interact with key stakeholder to develop solutions to complex issues.
• May participate in compliance audits as required.
• Promote a quality mindset and quality excellence approach to all activities.

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.
• Knowledge in both clinical and commercial product desired.
• Strong Management and process improvement skills.
• Demonstrated experience managing batch record review and deviations.
• Great organization skills and have an attention to details.
• In-depth understanding of biologics manufacturing operations.
• Good 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.