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 technical writing* Thorough knowledge and understanding of the technical and commercial aspects of pharmaceutical API products, Current Good Manufacturing Practices {part of GxP}, validation principles, and applicable regulations* Extensive experience with Quality Management Systems.* Ability to learn and operate various enterprise systems including LIMS, SAP, OSI/PI, EMS, BMS, is required* Regardless of format, able to carry all technical communications which will allow the end-user, specifically QA personnel and regulatory inspectors, to arrive at the intended conclusions.* Knowledge of GXP regulations and guidance.* Ability to effectively coach and train employees.* Demonstrate high-level of communication for cross-functionally and across levels, including timely identification of potential sources of conflict and resolve independently or escalate to stakeholders promptly.* Excellent verbal and written communication skills, with the ability to share vision, direction, and data with colleagues across all levels and in a wide range of different work groups* Strong ability to balances the speed of delivering work with quality and shows commitment to make improvements in both aspects* Demonstrate a high degree of engagement and involvement in all job-related activities. Catalyst for selecting methods, techniques and evaluation criteria for obtaining results. Mentor junior members of team on technical topics. May potentially be a Qualified Trainer on investigation process* Operations experience in one or more of the following areas: Quality Assurance, Quality Control, Manufacturing Technical Support, Facilities Engineering, or Automation.* Keeps tasks (deviations, CAPA, or CCR) on schedule, tracks them carefully, and delivers results on time; seeks assistance to solve a problem quickly to adhere to on-time delivery* Experience with project management* Experience in supervisory teams* Ability to lead staff in absence to people manager* Ability to gown and gain entry to manufacturing areas.* Ability to work off shift hours, seldom, to support product release* 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. #J-18808-Ljbffr