Head of Quality Assurance Operations

Job Title: Head of Quality Assurance Operations

Location: Framingham, MA - Northborough, MA

Site Function: Quality Assurance Operational management

About the job
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.

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, will be day to day quality oversight of all manufacturing operations, providing input, judgement and decision making to assure product quality and compliance. In addition, you will be responsible for reviewing and assessing all manufacturing and QC GMP documentation to disposition drug substance per operational plan. Ready to get started?

Main Responsibilities:

• Batch review and preparing batch disposition for all intermediates and finished goods manufactured in his/her area. (final accountability is under the QP or equivalent)​

• Review and prepare manufacturing documentation for Batch disposition by QP (A)​

• Develop and implement the annual quality assurance operation objectives in alignment with the organizational strategy, vision, and objectives ​

• Define initiatives to improve quality assurance operation processes and systems (D).​

• Implement quality operation procedures supporting the manufacturing activities​

• Identify and escalate possible quality alert risks (A)​

• Ensure the timely closure of quality events such as deviations, CAPAs, and change controls to maintain compliance and operational efficiency​

• Provide support to quality control processes and improvements (A)​

• Overseeing the entire manufacturing process to ensure that all steps are validated and adhere to Standard Operating Procedures (SOPs) ​

• Follow progress on quality improvement projects and initiatives (I)​

• Monitor key performance indicators (KPIs) and metrics for the quality assurance operation, and report on the performance and effectiveness.​

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

• Promote a culture of quality and continuous improvement. Identify and drive continuous improvement initiatives and projects to enhance the quality assurance operation efficiency and effectiveness.​

• Lead and manage the quality assurance operation team, including hiring, training, coaching, professional development and performance evaluation​

• Travel between the Framingham and Northborough locations will be frequent.

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About You

• Earned Bachelor's degree in relevant or scientific field

• Six years of experience in quality assurance (preference is 10) within the pharmaceutical industry (again, preferred)

• Biologics process experience is critical for this role

• Leadership or managerial role within quality assurance is ideal.​

• Extensive knowledge of quality assurance principles, standards, methodologies, and tools​

• History of leadership and effective collaboration specifically with manufacturing teams/departments

• Exposure to digital systems such as DeltaV, 1LIMS, MES, etc. is very helpful

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Why Choose Us

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse 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.​

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