Manager, Quality Operations - Vaccine

Role Summary

The Manager of Quality Operations ensures internal and external compliance to Sanofi’s Standard Operating Procedures and that current industry standards are met throughout the development life cycle of Sanofi’s products. This role provides leadership and direction to the Operational Quality team and helps evolve the Quality mindset across the organization. This is a Manager-level position reporting directly to the Head of Quality. Location: Waltham, MA.

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 other critical topics in a timely manner to the appropriate management level and/or to relevant project team members.
• Assist in the development and maturation of strategic planning to meet Quality KPIs and goals, 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; lead 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, 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 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, and communicate proactively to senior management any issues for resolution.
• Ensure the Waltham Quality department meets 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 and CDMOs; align Quality Systems and requirements; work with global Quality and technical teams to assess and resolve discrepancies and non-compliance events through investigations and risk assessments.
• Communicate significant quality risks that may impact product suitability or regulatory compliance to the Head of Quality and key business stakeholders in a timely and effective manner.
• 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 to help build relationships for team members’ execution of tasks.
• Support and improve processes and SOPs in the areas of Deviations/Investigations, CAPAs and Change Control as needed.
• Support and improve the Inspection Readiness Program as needed.
• Support and improve Internal and External Audit schedules/programs as needed.
• Ensure implementation and evaluation of corrective and preventive actions to address systemic issues.
• Motivate and coach the Quality Operations team to operational success, focusing on quality delivery and customer satisfaction.
• Lead by example to promote high standards and ensure team members understand the expected quality and compliance behaviors.
• Develop and maintain strong relationships with internal and external stakeholders to ensure optimal performance for Quality Operations.
• Review and update company records, including Policies/SOPs, performance reviews, and risk assessments.
• Communicate key performance indicators (KPIs) from senior leadership to the team to align efforts with company goals.

Qualifications

• Earned Bachelor's degree (Master's degree preferred) within a STEM discipline.
• Pharmaceutical/biotechnology industry experience (12+ years) with at least 10 years in a Quality function (Quality Assurance highly preferred).
• Experience in compliance with US, EU and ICH GMP requirements, including reviewing submission documentation, responses to regulatory inquiries and inspections.
• Strategic experience with senior leadership-level clients, strong decision-making capability and personal accountability within the organization.
• Expert knowledge and experience with data analysis, reporting, and trending.
• Proven success in identifying and implementing organization-wide operational excellence/improvement initiatives.
• Preferred experience with outsourced manufacturing and testing operations.
• Strong leadership and management experience 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 direct authority may be limited, i.e., influence beyond your role.
• Ability and desire to work in a fast-paced, start-up environment.
• Strong collaboration and team-building skills with effective communication.
• Independently motivated and detail-oriented with good problem-solving ability.
• Demonstrated effective time management skills.
• Sound judgment and commitment to ethical conduct.