Associate Director, Quality Operations - Vaccines

About the Opportunity
The Associate Director of Quality Operations is responsible for ensuring our Quality organization meets all compliance requirements pertaining to Good Laboratory Practices (GLP), current Good Manufacturing Practices (cGMP), FDA, ICH and EMA regulations. The Associate Director of Quality Operations will be responsible for developing policies and programs in the support of the Quality Managers in their disposition of Product for Sanofi Waltham's mRNA Center of Excellence, inclusive of review and release of manufacturing/test documentation from process development, manufacturing, non-clinical and clinical processes and supply chains. This includes batch records, deviations, CAPAs, CoAs, CoCs, etc. This individual will also help with management of contract organizations such as CMOs, CROs and CTLs by providing senior level support to the managers leading those efforts.
This position is based in the Waltham, MA offices. The ideal candidate will live within a reasonable commuting distance, or be willing to relocate at their own expense.
Key Responsibility for position:
The Associate Director ensures internal and external compliance to Sanofi's Standard Operating Procedures, and that current industry standards and practices have been met throughout the development life cycle of Sanofi's products. This AD level 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 would be an independent contributor at a senior level reporting directly Head of Quality.
General and Task Management

• 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.
• Partner with Analytical Development, QC, Internal Manufacturing and Quality Operations colleagues to strategically develop and implement a phase appropriate approach to quality assurance and quality assurance systems.
• Help establish and maintain phase-appropriate cGMP compliance for product manufacturing, testing and stability; assisting the team to ensure appropriate review and assessment of production records, in-process and release testing methods, specifications, validations, reference materials and test results.
• 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.
• People Management< >No direct reports, will serve as an independent contributor.

Competencies / Requirements for position

• BS (required), MS (preferred), degrees within a STEM (Science, Technology, Engineering or Mathematics) discipline.
• Pharmaceutical/biotechnology industry experience (15+ years) with at least 10 years in a Quality function required.
• Strategic experience with senior leadership team level clients, strong decision making capability and personal accountability within the organization.
• Strong leadership and management experience with the ability to work in a matrix environment.
• Preferred experience with outsourced manufacturing and testing operations.
• Experience in working in compliance with US, EU and ICH GMP requirements, experience reviewing submission documentation, responses to regulatory inquiries and inspections.
• Excellent written and verbal communication skills including the ability to communicate and negotiate across the organization, at all levels.
• Expert knowledge and experience with data analysis, reporting, and trending.
• Proven success in identifying and implementing organization-wide operational excellence/improvement initiatives.
• 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.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
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