Head of Quality Assurance Operations (Drug Product)

About the role

Join a global network that powers how Sanofi delivers seamlessly, purposefully, and at scale. In 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.

As Head of Quality Assurance Operations (Drug Product), you will lead the Drug Product Quality Assurance team, accountable for quality oversight of the entire drug product manufacturing process at the Sanofi Swiftwater Site. This role provides leadership and direction for quality oversight of sterile drug product manufacturing (Formulation, Filling, Inspection, Packaging, Release, and Distribution) and collaborates with highly skilled colleagues toward an inspiring mission of creating high-quality, life-saving vaccines and products.

You will lead a team of quality leaders (QA Operational Managers) overseeing quality professionals within structured Process Centric Units (PCU) and 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).

Responsibilities

• Batch review and preparing batch disposition for all intermediates and finished goods manufactured in their area (final accountability is under the QP or equivalent depending on local regulations).
• Ensuring readiness for inspection by national and international agencies through implementation of corresponding specific requirements (e.g., Device, MTI).
• 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) 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) 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.
• Ensuring strong cross-functional collaboration between Regulatory Affairs, Supply Chain, Manufacturing leadership, and other Quality functions.
• Serving as a member of the Site Quality Leadership team and representing Quality within the Drug Product Manufacturing Ecosystem.

Key Involvement in Decision Making:

• Review and prepare manufacturing documentation for batch disposition by QP (A)
• Define initiatives to improve quality assurance operation processes and systems (D)
• Identify and escalate possible quality alert risks (A)
• Provide support to quality control processes and improvements (A)
• Follow progress on quality improvement projects and initiatives (I)
• Proactively implement remediation action from findings from internal and external audits related to quality assurance operation (I)

(D) = Decision maker | (A) = Active contributor | (I) = Informed

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 role.
• 5+ years of experience in sterile/aseptic drug product manufacturing.
• Proven ability to present and defend quality-related topics in regulatory inspections (including, but not limited to FDA/EMA).

Skills

• Strong knowledge of Good Manufacturing Practices (GMP) and quality assurance principles.
• Ability to analyze complex data and identify trends, issues, root cause, and solutions.
• High level of accuracy and attention to detail in all quality assurance activities.
• Strong verbal and written communication skills for effective interaction with team members and regulatory bodies.
• Proficiency in identifying problems and implementing effective corrective actions.
• Ability to manage multiple projects simultaneously, ensuring timely completion and adherence to quality standards.
• Expert in multiple root cause analysis techniques and structured problem-solving methodologies.
• Fluent English (spoken and written) required; local language fluency may be required.
• Strong knowledge of drug product operations including Formulation Filling (RABS and Isolators), Manual and automated visual inspection, Packaging (including labeling and serialization), and release requirements.
• Ability to lead and influence at all levels.
• High level of autonomy.
• Strong Computer Literacy (including Microsoft Excel, PowerPoint, Word).

Preferred qualification: ASQ, CQE, Six Sigma.

Benefits

• Be part of an inspiring mission to create life-saving vaccines.
• Lead a skilled and motivated team of quality professionals.
• Highly collaborative and technical vaccine manufacturing operation on a beautiful, park-like campus.
• Countless opportunities to explore, make connections, and grow your career, whether through promotion or lateral moves, at home or internationally.
• Thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
• Wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs, and at least 14 weeks gender-neutral parental leave.