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Sanofi Group Change Control Assessment & Coordination (CCAC) Leader - Vaccine in Swiftwater, Pennsylvania

The Change Control Assessment & Coordination (CCAC) Leader has the responsibility for managing the Transversal Activities of Change Control Assessment & Coordination (CCAC) group. For these activities, this position acts as a Single Point of Contact for the coordination of related requests emanating from both local and global Industrial Affairs and Regulatory Affairs and ensures optimal processes and related procedures.

The CCAC Leader ensures the performance and integrity of the CCAC team and its members and is responsible for:

Staff management and development :

o Provides support and development of staff including coaching and performance appraisal of staff as appropriate

o Provides technical and regulatory oversight and guidance to direct reports and as required to Reg CMC and other functional areas at the site.

o Ensures that all staff meet appropriate Health & Safety, Quality and Training objectives.

Leadership :

o Represents RA as key partner and primary point of contact for Quality Change Management including representation at Site Change Control Committee Meetings and Screening Group meetings.

Change Control Assessment :

o As part of the global team, coordinates the timely screening and assessment of appropriate and consistent regulatory reporting and associated strategies to worldwide Health Authorities for industrial and quality changes coordinated at all manufacturing sites in scope

o Ensures entry of those Regulatory assessments into the Regulatory databases (e.g. RegFast)

o Ensures communication of key country assessments to Quality Operations to facilitate IA action planning and appropriate blocking of batches pending regulatory approvals.

o At the time assessment of Annual report level changes, completes the Annual Report Forms (US) or, tabular List (CA)

o Ensures maintenance of CCR tracking and information in the different RegCMC Sharepoints and provides regular reporting of Change Assessment metrics to management

Regulatory Guidance :

o Promotes clarity of the regulatory environment for assessment through liaison with Reg CMC & D Excellence Platform to ensure that assessment tools in use are current and appropriate

o Interacts as appropriate with Health Authorities to influence the regulatory environment in regard to regulatory reporting of industrial and Quality changes.

Health Authority (HA) Inspection Preparation/Support :

o May participate and provide support in inspection preparation and inspections, as requested

Knowledge and Skills:

  • Strong competency in “Make Decisions” and “Think Strategically”

  • Demonstrated critical thinking and leadership skills

  • Understanding of:

  • Process validation

  • Test methodology

  • Sterility Assurance

  • Stability Monitoring

  • Regulations and Guidelines from various countries which govern changes to marketed products.

  • Technical and regulatory requirements related to CTD

  • Familiarity with ICH guidelines, and Pharmacopoeias

  • Knowledge in electronic documents management systems, databases and MA dossiers.

  • Good level of expertise in planning methods and tools.

  • Ability to coordinate, organize and plan in an efficient and effective manner.

  • Ability to deal with conflicting priorities in constantly changing environment.

  • Negotiation and communication skills with internal and external stakeholders.

  • Ability to work in multidisciplinary and multicultural environment.

Experience Required:

  • At least 5-7 years in Regulatory Affairs or Quality Assurance with Change Control experience preferred.

  • Experience in dossier submissions to Health Authorities.

  • Experience in project and dossier planning.

  • Experience in a Team leadership role preferred.

  • Experience with international regulations and submissions would be beneficial

At Sanofi R&D North America, we deliver meaningful solutions for patients. We transform science into breakthrough, best-in-class and first-in-class medicines and vaccines. We believe in creating a diverse and inclusive workforce – and workplace – which brings together the collective brainpower of over 2,000 colleagues and provides you with an exciting place to grow and develop. We set the bar high, and we deliver. Join us and together we will build on our trusted legacy of breakthroughs for society.

As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health.This position will require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities.

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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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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