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Sanofi Group Director Quality in Waltham, Massachusetts

POSITION OVERVIEW

The Speciality Care External Supply (SCES) Quality Director provides quality leadership and compliance oversight to internal and external customers. Operates within product teams and provides expert input into quality issues associated with ongoing operations, projects and programs. Drives continuous improvement initiatives within the department and the wider Sanofi organization.

Core Responsibilities

Staff Management

  • Select, develop, and motivate qualified staff to effectively carry out department functions and provide for the continuity of managerial and specialized skills.

  • Ensure that areas of responsibility are staffed, organized and resourced to ensure compliance obligations are fulfilled.

  • Provides leadership, guidance, and direction to staff consistent with GxP and corporate governance.

  • Coach and mentor staff in all aspects of their job performance and career development including training, feedback, rewards and disciplinary action.

  • Develop a cohesive team, maintain and reinforce a strong quality presence, encourage positive relationships and network effectively across functional areas.

  • Develop work plans, assign tasks, and lead team(s).

  • Manage staffing requirements based on projects.

  • Provide organizational and managerial structure that supports the various levels in the organization.

  • Ensure staff has appropriate knowledge of department processes and procedures.

Budget

  • Provide input into the department/cost center budget as required.

  • Manage cost center budget for forecasting, headcount, project allocation, and department spending as required.

Department Management

  • Align department objectives with Sanofi Biologics business objectives.

  • Responsible for strategic planning and development activities including compliance, capacity, timelines and corporate direction as required.

  • Collaborate with senior management, peers and team to build and implement a long term vision for the department and external collaborations.

  • Identify quality improvement opportunities within operations and partner with peers to develop and implement solutions.

  • Collaborate with senior leadership team in meeting corporate and organizational goals.

  • Establish and report applicable department or organizational metrics.

  • Act as a subject matter expert and resource to peers and colleagues across the Biologics network.

  • Represent department or organization in project team meetings related to corporate initiatives.

  • Interact with project teams and cross functional groups.

  • Accountable for oversight of self-inspection programs as required.

  • Ensure that site practices are consistent with corporate quality standards as appropriate.

  • May interface with vendors as required.

  • Interface with external regulatory agencies as required.

Additional Responsibilities

  • May be assigned a leadership role (e.g. Primary Process Owner or Site Process Owner) in a Community of Practice, e.g. Supplier Management.

Basic Qualifications

  • Bachelor’s degree and 15+ years of experience in the pharmaceutical/biotech industry

  • 10+ years of experience in a Quality function.

  • 5-10 years supervisory and/or management experience.

Preferred Qualifications

  • Experience with all aspects of Quality related to technology transfer, validation, and routine oversight of processes and analytical methods at contract manufacturing / testing sites

  • Familiarity with global GMP and ISO regulations relating to medicinal products

  • Excellent communication and negotiation skills.

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.

#GD-SG

#LI-GZ

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.

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