Head of Quality Assurance Operations (Drug Product)

Job title: Head of Quality Assurance Operations (Drug Product)

Location: Swiftwater, PA (Hybrid)

About the job

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. 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?

About Sanofi

We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.

Main Responsibilities:

• Batch review and preparing batch disposition for all intermediates and finished goods manufactured in their area. (final accountability is under the QP (qualified person, Pharmacien delegue…) or equivalent depending on local regulations)

• 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

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

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 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)

• Proactively implement remediation action from findings from internal and external audits related to quality assurance operation (I)

• Preferred qualification (ASQ, CQE, Six Sigma)

Skills/Knowledge:

• 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, power point, word)

Why Choose Us?

• Bring the miracles of science to life alongside a supportive, future-focused team. 

• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally. 

• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. 

• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave. 

Sanofi US Services and its U.S. affiliates are Equal Opportunity employers committed to a culturally inclusive workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. 

#GD-SP ​ 
#LI-SP 

#LI-Onsite

#vhd

All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.