Manager, Quality Operations - Vaccine

Role Summary

Manager, Quality Operations - Vaccine is responsible for ensuring internal and external compliance with Standard Operating Procedures and current industry standards throughout the development life cycle of Sanofi’s vaccine products. This role leads the Operational Quality team, influencing and evolving the Quality mindset within the organization. It reports to the Head of Quality.

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, interfacing with front line managers in coaching and mentoring quality-related decision making.
• Help establish and maintain phase-appropriate cGMP compliance for product manufacturing, testing and stability; lead the team to ensure appropriate review and approval of master production records, executed production records, in-process and release testing, specifications, reference materials, test results, etc.
• Serve as Quality Assurance for all documentation generated during the execution for CoE Raw Materials, QC Lab and Manufacturing support, including the Stability program (but not Batch Release activities).
• Quality oversight for external manufacturing of Lipids, Enzymes, pDNA and master cell banks.
• Build and manage Quality-to-Quality relationships with CDMOs, including periodic visits and representation on CDMO project teams.
• Harmonize Ways of Working between the Waltham and France Center of Excellence facilities toward Operational Excellence.
• Establish and track Quality metrics, communicating issues to senior management for resolution.
• Ensure Waltham Quality department meets standards expected by US and global regulatory authorities and Sanofi Global Standards.
• Maintain effective Quality governance and provide guidance to ensure ongoing compliance with the operational team.
• Establish relationships with external manufacturers and align Quality Systems with CDMOs; investigate and resolve discrepancies and non-compliance events.
• Communicate significant quality risks to the Head of Quality and key stakeholders.
• Review and edit Quality Technical Agreements, contracts, and supplier agreements to provide quality input to project plans and statements of work.
• Work cross-functionally representing the Quality group on discovery and development teams and to senior management for awareness of quality/regulatory requirements.
• Collaborate with Business Partners within the Sanofi organization to support task execution.
• Support and improve processes and SOPs in Deviations/Investigations, CAPAs and Change Control.
• Support and improve the Inspection Readiness Program and Internal/External Audit schedules/programs.
• Promote a quality mindset within GxP operational areas and ensure risk-based, innovative decision-making.
• Implement and evaluate corrective and preventive actions to address systemic issues.
• Motivate and coach the Quality Operations team toward quality delivery and customer satisfaction.
• Lead by example to uphold standards and behaviors related to quality and compliance.
• Develop and maintain relationships with internal and external stakeholders for optimal Quality Operations performance.
• Review, implement and update company records (Policies/SOPs, performance reviews, risk assessments, etc.).
• Communicate Key Performance Indicators from SLT to align and motivate the team toward company goals.

Qualifications

• Earned Bachelor's degree (required; Master's degree preferred) in a STEM discipline.
• Pharmaceutical/biotechnology industry experience (12+ years) with at least 10 years in a Quality function (Quality Assurance highly preferred).
• Experience in US, EU and ICH GMP compliance, reviewing submission documentation, regulatory inquiries and inspections.
• Strategic experience with senior leadership and strong decision-making and accountability.
• Expert knowledge in data analysis, reporting, and trending.
• Experience identifying and implementing organization-wide operational excellence initiatives.
• Preferred experience with outsourced manufacturing and testing operations.
• Strong leadership and matrix management experience.
• Excellent written and verbal communication, with ability to influence across the organization.
• Ability to work across functions at all levels without direct authority.
• Ability and desire to work in a fast-paced, start-up environment.
• Strong collaboration, team-building, and communication skills.
• Independently motivated, detail-oriented, good problem-solving ability.
• Effective time management and sound judgment.

Skills

• Quality Assurance, cGMP, regulatory compliance
• Quality metrics and governance
• CAPA, Deviations, Change Control
• CDMO management and external manufacturing oversight
• Risk assessment and investigations

Education

• Bachelor's degree in a STEM field (required); Master‚Äôs degree preferred