Associate Director, QA Operations, Drug Product

Moderna Therapeutics - Norwood, MA

Full-time - Mid Level

Norwood, MA

Professional, Scientific, and Technical Services

About the position

The Associate Director, QA Operations at Moderna, Inc. is a pivotal role that reports directly to the Director of QA Drug Product. This position is responsible for leading the quality and compliance readiness for a cutting-edge Drug Product (Fill Finish) cGMP manufacturing facility. The primary focus is to ensure operational readiness for the production of both clinical and commercial drug products while strictly adhering to current Good Manufacturing Practices (GxP), corporate policies, regulatory requirements, and industry best practices. This role encompasses providing cross-functional support for Commissioning, Qualification & Validation (CQV) activities that are essential during the facility start-up phase. The Associate Director will execute a comprehensive project quality plan that includes regulatory inspection readiness. This involves liaising with key stakeholders to navigate the facility integration strategy and ensuring that the appropriate quality systems and operational processes are developed, implemented, and maintained for a seamless start-up and routine operation of the facility. Once the facility is operational, this role will provide end-to-end quality oversight for drug product operations, ensuring compliance with cGMPs, company procedures, and regulatory requirements. In this capacity, the Associate Director will play a crucial role in establishing the operational strategy, implementing best practices, and building a high-performing team to achieve excellence in manufacturing operations while maintaining regulatory compliance and quality standards. The individual will be at the forefront of Moderna's mission to deliver mRNA therapies to patients worldwide, utilizing their expertise to ensure the smooth operation of manufacturing processes that directly contribute to the production of transformative therapies for patients.

Responsibilities

• Establish robust operational readiness plans to transition from the construction phase to full-scale production, ensuring all systems and processes are in place for cGMP compliance.
• Develop, lead, and manage the execution of a project quality plan, embedding an audit readiness component that factors in all potential risks and mitigations associated with the project.
• Oversee the hiring, training, and development of a high-performing Quality Operations team capable of providing Quality oversight across multiple Drug Product filling lines.
• Develop and implement operational and quality systems, ensuring Quality 4.0 / Pharma 4.0 principles are embedded into their design.
• Collaborate with cross-functional teams in a highly matrixed environment to drive decisions and influence outcomes for Moderna's clinical pipeline.
• Ensure detailed lessons learned are executed, documented, and disseminated to respective personnel upon project closure.
• Develop and track performance of quality and operational process readiness against pre-defined milestones, reporting on progress, risks, and resolutions through governance channels.
• Provide expert guidance and support while managing interfaces with key business stakeholders for quality and operational processes.
• Provide leadership to ensure a Right-First-Time and mature quality culture is developed and maintained within the project, leading to a successful PAI outcome.
• Support/lead troubleshooting of complex issues encountered during CQV activities and provide support for CQV deviations and change management teams.
• Represent quality in cross-functional project meetings; recruit, develop, and lead personnel to ensure department and project objectives are met.
• Ensure timely resolution and/or escalation of quality issues to senior management.
• Support the development of policies and procedures in the evolution and continuous improvement initiatives of the Global Quality Management System.
• Identify and implement tools and electronic Quality systems to improve processes in partnership with the Digital team.
• Lead risk management activities to identify potential operational issues and implement mitigation strategies.
• Ensure adherence to all environmental, health, and safety guidelines, promoting a culture of safety within the operations team.
• Establish key performance indicators (KPIs) to measure and report on operational performance, making data-driven decisions to optimize processes.
• Foster a culture of innovation and collaboration, encouraging team members to contribute ideas for process improvements and operational excellence.
• Serve as the primary point of contact for operations during regulatory inspections and audits.
• Drive continuous improvement initiatives to enhance operational efficiency, reduce costs, and improve product quality.

Requirements

• Bachelor of Science degree in Engineering, Pharmaceutical Sciences, or a related technology discipline.
• A minimum of 8 years of experience in aseptic drug product manufacturing, with at least 3 years in a leadership role.
• Problem-solving mindset with a commitment to quality and safety.
• In-depth knowledge of cGMP regulations, aseptic processing, and cleanroom operations.
• Strong leadership skills with the ability to develop and motivate a diverse team.
• Excellent project management, organizational, and communication skills.
• Demonstrated ability to work cross-functionally and manage complex projects with multiple stakeholders.

Nice-to-haves

• Proven track record of successful facility start-ups or major operational projects within the pharmaceutical industry.
• Experience with budget management and cost optimization in a manufacturing environment.
• A desire to make an impact as part of a high-growth, transformational company.

Benefits

• Highly competitive and inclusive medical, dental and vision coverage options
• Flexible Spending Accounts for medical expenses and dependent care expenses
• Lifestyle Spending Account funds for personal enrichment and self-care activities
• Family care benefits, including subsidized back-up care options and on-demand tutoring
• Free premium access to fitness, nutrition, and mindfulness classes
• Exclusive preferred pricing on Peloton fitness equipment
• Adoption and family-planning benefits
• Dedicated care coordination support for the LGBTQ+ community
• Generous paid time off, including vacation, sick time, and holidays
• Volunteer time to participate within the community
• Discretionary year-end shutdown
• Paid sabbatical after 5 years; every 3 years thereafter
• Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
• 401k match and Financial Planning tools
• Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options
• Complimentary concierge service including home services research, travel booking, and entertainment requests
• Free parking or subsidized commuter passes
• Location-specific perks and extras!