Principal Manufacturing Compliance Engineer

Principal Manufacturing Compliance Engineer owns and ensures a robust investigations process, uses expert knowledge of compliance and GXP manufacturing processes to manage investigations, improvement initiatives, and major projects within manufacturing operations.
* Practice and promotes safe work habits and adheres to Sanofi’s safety procedures and guidelines.
* Lead and perform investigations, CAPAs and Change Controls (CCRs) for on-time closure and supporting Annual Product Reviews.
* Provide guidance and direction to team to drive complex investigation close outs, determine root cause and implement appropriate Corrective and Preventative Action.
* Utilize manufacturing process knowledge and investigation skill sets to identify and resolve manufacturing issues, improve process operations, and affect positive change.
* Represent Manufacturing Compliance Engineer team on cross-functional teams involved in the design and implementation of new or updated quality systems in accordance with the corporate standards, regulatory standards, cGMP, and industry standards.
* Actively participate and provide input and feedback to cross functional teams to ensure alignment on investigations and identified corrective and preventative actions.
* Escalate to management when investigations pose risk shipment or release and impact to department and site metrics.
* Maintain and report applicable department or organizational metrics
* Routinely perform trend and statistical analysis as required to identify continuous improvement opportunities within manufacturing functional groups
* Work to develop strategy and action plans for improving the system where opportunities are identified.
* Lead and actively participate in cross-functional continuous improvement projects with Manufacturing, Engineering, Validation, Quality Assurance, Quality Control, Facilities, Metrology, and Manufacturing Technical Services.
* Recognize and act on potential compliance issues and opportunities for process changes/improvement.
* Provide front room support during regulatory inspections
* Represent investigation team during internal and external GxP audits.
* Partner with cross functional teams and team members, direct and indirect management chain to ensure the following: Ø Participate in timely completion of investigation, deviations and CAPA Ø Facilitation, Collaboration, completion, and active follow-up
* Support investigation team to ensure site Key Performance Indicators (KPIs) are consistently met
* Use experience and knowledge of manufacturing functional areas to propose continuous improvements to deliver efficiency gains.
* Assess customer needs and provides effective solutions through regular analysis of data and information reported from a broad variety of sources.
* Routinely assess progress made against Key Performance indicators to reach individual and team goals.
* Sensitive to the broader work environment and fosters relationships with partners, experts from other functions and customers in order to achieve tactical objectives.
* Monitor Quality Systems (e.g., investigations and CAPAs) activities to ensure compliance with company and regulatory standards.
* Assist with Quality Management Review (QMR)/Quality Council.
* Support Corporate Compliance initiatives.
* Adhering to all applicable laws and regulations of the places in which we conduct business, as well as our own Company policies and procedures.
* Being honest and treating people with respect and courtesy.
* Constantly striving to make Sanofi's a great place to work and a company respected for the quality of its people and products.
* Acting as role models for our fellow employees by acting responsibly, fairly and honestly in our dealings and exercising sound judgment in performing our jobs.
* Bachelor's degree in Sciences, Technical, Engineering or Advanced degree with 8 years in a cGXP manufacturing environment or a Master’s degree in Sciences, Technical, Engineering or Advanced degree and 3 years of experience in cGXP manufacturing environment.
* Experience in troubleshooting, investigation, and root cause analysis in a cGMP environment
* Proficiency with critical thinking and…