Head of Quality Assurance Operations; Drug Product

Head Of Quality Assurance Operations (Drug Product)

Location:

Swiftwater, PA (Hybrid)

Join a global network that powers how Sanofi delivers — seamlessly, purposefully, and  Manufacturing & Supply, you'll help reimagine how life-changing treatments reach people everywhere, faster.

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. Your job, as Head of Quality Assurance Operations (Drug Product) is to lead the Drug Product Quality Assurance team.

The role is accountable for quality oversight of the entire drug product manufacturing process at the Sanofi Swiftwater Site.

What makes this position unique?

This role provides leadership and direction for quality oversight of the sterile drug product manufacturing (Formulation, Filling, Inspection, Packaging, Release, and Distribution). This leadership role collaborates with a group of highly skilled and technical colleagues toward an inspiring mission of creating high quality life-saving vaccines and products. Head of Quality Assurance Operations (Drug Product) will lead a team of quality leaders (QA Operational Managers) who oversee quality professionals within structured Process Centric Units (PCU) and will act as the QA Drug Product Ecosystem lead.

This includes oversight of final batch release and lot disposition for product distributed from the Sanofi Swiftwater Site and release from relevant Commercial Manufacturing Organizations (CMOs). The QA DP Ecosystem will have quality oversight of the Drug Product Manufacturing organization.

Benefits of working in this role:

• Be part of an inspiring mission to create life-saving vaccines
• Leading a skilled and motivated team of quality professionals
• The work environment is a highly collaborative and technical vaccine manufacturing operation on a beautiful park like campus.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people's lives. We're also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Main Responsibilities:

• Batch review and preparing batch disposition for all intermediates and finished goods manufactured in their area.
• In case of specific regulation link to their area (e.g., Device, MTI): ensuring readiness for inspection by national and international agencies through implementation of corresponding specific requirement
• Developing and implementing the annual quality assurance operation objectives in alignment with the organizational strategy, vision, and objectives
• Developing and implementing quality operation procedures supporting the right operation of the manufacturing activities
• Maintaining a system to ensure compliance and quality risks are properly identified, tracked, and mitigated
• Ensuring the timely closure of quality events such as deviations, CAPAs, and change controls to maintain compliance and operational efficiency
• Overseeing the entire manufacturing process to ensure that all steps are validated and adhere to Standard Operating Procedures (SOPs)
• Establishing and monitoring KPIs for the QA Operations DP team performance (e.g., deviation closure rates, batch review cycle time, CAPA effectiveness, etc.) to assess team efficiency and drive continuous improvement
• Establishing and monitoring quality metrics for manufacturing area oversight (e.g., batch quality trends, right-first-time rates, OOS/OOT occurrences, etc.) to identify production risks, drive corrective actions, and report on operational quality performance
• Promoting a culture of quality throughout the quality assurance operation organization within their area of responsibility
• Identifying and driving continuous improvement initiatives and projects to enhance the quality assurance operation efficiency and effectiveness fostering a culture of continuous improvement
• Evaluating and recommending new technologies, tools, and methods and promoting innovation to enhance quality assurance operation processes and outcomes
• Leading management reviews to assess the effectiveness of the quality assurance operation
• Leading and managing the quality assurance operation team, including hiring, training, coaching, professional development, and performance evaluation
• Ensure strong cross-functional collaboration between Regulatory Affairs, Supply Chain, Manufacturing leadership, and other Quality functions
• Member of Site Quality Leadership team and represents Quality within the Drug Product Manufacturing Ecosystem

About You

Requirements:

• Bachelor's Degree in Life Sciences, Engineering or other applicable discipline
• 10+ years of experience in quality assurance within the pharmaceutical industry
• 5+ years in a people leadership…