Senior Manager, Quality Assurance, Drug Product

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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.

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.