• 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 actions to address systemic issues.
• Motivate and coach the Quality Operations team to operational success- both in terms of quality delivery and customer satisfaction.
• Consistently promote high standards through personal example and lead the team in a manner that each member understands the standards and behaviors expected of them in relation to quality and compliance.
• Develop and maintain strong relationships with internal and external stakeholders to ensure optimal performance for Quality Operations.
• Review, implement and update company records- Policies/SOPs, performance reviews, risk assessments, etc.
• Communicate to the team Key Performance Indicators from SLT down, in a manner that each employee is in alignment with company goals and motivated to achieve success.
• Develop and maintain strong relationships with internal and external stakeholders to ensure optimal performance for Quality Operations.

About You:

• Earned Bachelor’s degree (required, Master’s degree preferred) within a STEM (Science, Technology, Engineering or Mathematics) discipline.
• Pharmaceutical/biotechnology industry experience (12+ years) with at least 10 years in a Quality Assurance function.
• Experience in working in compliance with US, EU and ICH GMP requirements, experience reviewing submission documentation, responses to regulatory inquiries and inspections is needed.
• Strategic experience with senior leadership team level clients, strong decision making capability and personal accountability within the organization.
• Expert knowledge and experience with data analysis, reporting, and trending is extremely valuable.
• Proven success in identifying and implementing organization-wide operational excellence/improvement initiatives is highly desired.
• Preferred experience with outsourced manufacturing and testing operations.
• Strong leadership and management experience with the ability to work in a matrix environment.
• Excellent written and verbal communication skills including the ability to communicate and negotiate across the organization, at all levels.
• Demonstrated ability to work across functions at all levels where the incumbent may not have direct authority to accomplish objectives, i.e. influence beyond your role.
• Ability and desire to work in a fast-paced, start-up environment.
• Strong collaboration, team-building skills and communication skills.
• Independently motivated and detail-oriented with good problem-solving ability
• Demonstrated effective time management skills.
• Sound judgment and commitment to ethical conduct.