Manager, Internal Quality Operations

Responsibilities

• Oversee Quality Assurance operations for clinical-stage drug product manufacturing, including aseptic fill-finish and packaging processes.
• Serve as the primary QA contact for the development and startup of a new aseptic fill-finish manufacturing facility.
• Support equipment qualification, process validation readiness, and the implementation of quality systems.
• Provide operational support including batch record review, line clearance, visual inspection oversight, and in-process checks.
• Lead deviation investigations and change controls, coordinating root cause analysis and cross-functional impact assessments.
• Drive documentation improvements for batch records and standard operating procedures to ensure regulatory compliance.
• Facilitate technology transfer by coordinating with supply chain, engineering, and manufacturing science and technology teams.
• Support audit readiness for internal and third-party inspections and serve as the drug product Quality point of contact.
• Mentor and coach team members while contributing to hiring and continuous improvement initiatives.

Requirements

• Master’s degree in Biotechnology, Pharmaceutical Sciences, or a related field, plus two years of relevant QA/QC experience.
• Alternatively, a Bachelor’s degree with five years of progressive, post-baccalaureate experience in a related field.
• Proven experience with GMP compliance, audit readiness, and quality event management (deviations and CAPA).
• Proficiency in quality data analysis to drive continuous improvement.
• Experience utilizing eQMS, EAM, ERP, and MES platforms.
• Demonstrated experience providing QA support for facility-startup validation activities.

Benefits

• Best-in-class healthcare coverage and voluntary benefit programs.
• Holistic well-being resources including fitness, mindfulness, and mental health support.
• Family planning benefits, including fertility, adoption, and surrogacy support.
• Generous paid time off, including vacation, volunteer days, sabbatical, and global recharge days.
• Savings and investment opportunities.

About the Company

Moderna is pioneering the development of a new class of drugs made of messenger RNA (mRNA). Our mission is to deliver on the promise of transformative mRNA science to bring new medicines to patients and unlock the potential of this platform to treat serious diseases across diverse therapeutic areas.