Manager, Quality Operations - Vaccine

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* Job title:

** Manager, Quality Operations - Vaccine
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* Location:

** Waltham, MA                                        
** About the job
** The Manager of Quality Operations ensures internal and external compliance to Sanofi’s Standard Operating Procedures and that current industry standards have been met throughout the development life cycle of Sanofi’s products. This position will be responsible for helping provide leadership and direction to the Operational Quality team and will be responsible to influence and help evolve the Quality mindset with the organization.

This position is defined as a Manager level position reporting directly to the Head of Quality.

We are an innovative global healthcare company that helps the world stay ahead of infectious diseases by delivering more than 500 million vaccine doses a year. Across different countries, our talented teams are exploring new technologies to protect people and promote healthy communities. We chase the miracles of science every single day, pursuing progress to make a real impact on millions of patients around the world.
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* Main Responsibilities:

*** Partner with Analytical Development, QC, Internal/External Manufacturing and Quality Operations direct reports to strategically develop and implement a phase appropriate approach to quality assurance and quality assurance systems.
* Proactively communicate key issues and any other critical topics in a timely manner to the appropriate management level and/or to any other relevant project team member(s).
* Assist in the development and maturation of strategic planning to meet Quality KPIs and goals, while interfacing with front line managers in the coaching and mentoring of quality related decision making.
* Help establish and maintain phase-appropriate cGMP compliance for product manufacturing, testing and stability; leading the team to ensure appropriate review and approval of master production records (internal/external) executed production records (internal), in-process and release testing, specifications, reference materials, test results, etc.
* Serve as Quality Assurance for all documentation generated during the course of execution for CoE Raw Materials, QC Lab and Manufacturing support, to include the Stability program, but not Batch Release activities.
* Quality oversite for external manufacturing of Lipids, Enzymes, pDNA and master cell banks.
* Build and successfully manage Quality to Quality relationship with CDMOs, including periodic visits to CDMOs as required, and representing Sanofi QA on CDMO project teams.
* Build the strategic platform to harmonize Ways of Working between the Waltham and France Center of Excellence facilities, aligning both sites in a common approach to Operational Excellence.
* Establish and track Quality metrics, working with internal and external stakeholders while communicating proactively to senior management any issues for resolution.
* Ensure the Waltham Quality department meet standards expected by US, global regulatory authorities and Sanofi Global Standards- for research, development and ultimately commercial activities.
* Maintain an effective Quality governance and continually improve governance to meet business and compliance needs. Determine applicable quality standards and regulations and provide guidance and quality oversight to ensure ongoing compliance with the operational team.
* Establish strong working relationships with external manufacturers of our products and assure alignment of our Quality Systems and requirements with these CDMOs. Work with global Quality and technical teams to assess and resolve discrepancies and non-compliance events to ensure the quality of the product through performance of thorough investigations and risk assessments.
* Communicate significant quality risks that may impact product suitability or regulatory compliance, in both a timely and effective manner to the Head of Quality and key business stakeholders.
* Review and edit Quality Technical Agreements, contracts, supply agreements, etc- to provide quality input to project/program plans, master service agreements and statements of work.
* Work cross functionally, representing the Quality group on discovery and development teams, line functions and to senior management for awareness of and compliance with quality/regulatory requirements.
* Collaborate with key Business Partners within the greater Sanofi organization and help build relationships for team members execution of tasks.
* Supports and improves (as needed) processes and SOPs in the area of:
Deviations/Investigations, CAPAs and Change Control.
* Supports and improve (as needed) the Inspection Readiness Program.
* Support and improve (as needed) the Internal and External Audit schedules/programs.
* Promote a quality mindset within the GxP operational areas by ensuring consistent, risk based and innovative thought processes are employed to advise and make decisions.
* Ensure implementation and evaluation of corrective and preventative…