Head of QA Ops, APU 11 Forbes

Sanofi•Northborough, MA

13d•$133,500 - $192,833•Onsite

About The Position

The Head of Quality Assurance Operations is responsible for overseeing and managing all quality and compliance activities within the manufacturing facility, ensuring compliance with regulatory requirements, GMP standards, and organizational quality objectives. This role plays a critical part in maintaining product quality, driving continuous improvement, and leading a high-performing Quality team. 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.

Requirements

Bachelor's Degree in Life Sciences or related fields with 10+ years of experience in quality assurance within the pharmaceutical industry
Strong knowledge of Good Manufacturing Practices (GMP) and quality assurance principles
Experience in Drug Product Manufacturing
Ability to analyze complex data and identify trends, issues, 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
Inspection Management Experience at a Drug Product Manufacturing Site
Proficiency in identifying problems and implementing effective corrective actions
Ability to manage multiple projects simultaneously, ensuring timely completion and adherence to quality standards
English proficiency required.

Responsibilities

Review and prepare batch disposition for all intermediates and finished goods manufactured within the assigned area. Final accountability resides under the QAP (Qualified Authorized Person, or equivalent) depending on local regulations.
In case of specific regulations linked to the area (e.g., Device, MTI), ensure readiness for inspection by national and international agencies through implementation of corresponding specific requirements.
Develop and implement annual quality assurance operation objectives in alignment with the organizational strategy, vision, and objectives.
Develop and implement quality operation procedures supporting the proper execution of manufacturing activities.
Maintain a system to ensure compliance and quality risks are properly identified, tracked, and mitigated.
Ensure the timely closure of quality events such as deviations, CAPAs, and change controls to maintain compliance and operational efficiency.
Review and prepare manufacturing documentation for batch disposition by QAP
Define initiatives to improve quality assurance operation processes and systems
Identify and escalate possible quality alert risks, Provide support to quality control processes and improvements.
Follow progress on quality improvement projects and initiatives, Proactively implement remediation actions from findings of internal and external audits related to quality assurance operations.
Oversee the entire manufacturing process to ensure that all steps are validated and adhere to Standard Operating Procedures (SOPs).
Establish metrics and monitor data for quality assurance operation activities to identify trends and issues, and implement action plans accordingly.
Establish and monitor key performance indicators (KPIs) and metrics for the quality assurance operation, and report regularly on performance and effectiveness.
Promote a culture of quality throughout the quality assurance operation organization within the assigned area of responsibility.
Identify and drive continuous improvement initiatives and projects to enhance quality assurance operation efficiency and effectiveness, fostering a culture of continuous improvement.
Evaluate and recommend new technologies, tools, and methods, and promote innovation to enhance quality assurance operation processes and outcomes.
Lead management reviews to assess the effectiveness of the quality assurance operation and implement necessary adjustments.
Lead and manage the quality assurance operation team, including hiring, training, coaching, professional development, and performance evaluation.