Head of Quality Assurance Operations (Drug Product)

Sanofi•Pocono Township, PA

2d•$161,250 - $232,917•Hybrid

About The Position

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. 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.

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
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)

Nice To Haves

Preferred qualification (ASQ, CQE, Six Sigma)

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