mRNA CMC Project Quality Lead
mRNA CMC Project Quality Lead
In the race for the future of health – The Sanofi MRNA Center of Excellence (CoE)
At Sanofi, we believe in a world in which no one suffers or dies from vaccine-preventable diseases. And while the pandemic has shaken up our industry, creating new opportunities and risks, we believe the acceleration of innovation with mRNA technology means vaccines for more people faster than before. Bring your ambition and optimism for the future to Sanofi. Join us!
About the Opportunity:
The mRNA CMC Project Quality Lead will be responsible for leading quality related activities to ensure the successful launch of mRNA projects. He/She will represent Sanofi R&D Quality on mRNA CMC Project teams and are responsible to ensure R&D Quality provides effective and efficient input to CMC teams, providing leadership and direction for work activities of CMC Project Team Quality representatives in mRNA Site Quality functions, and direct oversight and input to manage Quality issues. He/She will ensure alignment with current regulatory requirements and company expectations and will directly influence & evolve the Quality strategy for future mRNA technologies through interaction with Health Authorities and use of compliance competitive intelligence. In addition, he or she will act as a primary interface with vaccine Industrial Affairs Quality and/or CMO-based organizations for late-phase manufacturing compliance topics, including support for transfer to an industrial setting for launch. Quality Due Diligence for major partnerships and or acquisitions will also under their responsibility.
The incumbent will work in a cross-functional, team-oriented organization with individuals from multiple R&D functions and Sanofi Quality units in different geographies and countries in order to implement quality and compliance practices and oversee timely delivery of QA contributions and activities for mRNA projects.
Direct interaction with R&D external partners and CMO organizations is part of the role and requires interface with Alliance Management and Legal functions, plus appreciation for relationship building to support and enable vaccine business needs.
In this role you will:
- Provide Quality support for mRNA CMC and supply chain activities to support development, manufacturing, release and shipments of drug substance and drug product, analytical method development and transfer, stability, and supply chain related activities
- Facilitate planning of Quality related CMC activities across drug substance, drug product and clinical supply chain to align dependencies, schedules, and delivery commitments
- Create, manage, and facilitate regular meetings, including the development of agendas, issue written minutes, and follow up on action items
- 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)
- Develop project plans with minimal support from others and works closely with project leads and/or department head
- Support CMC project lead/department head with the optimization of CMC project deliverables (schedules, resources, budgets)
Competencies / Requirements for position:
- Bachelor’s degree or Master’s degree in science, pharmaceutical sciences or related field
- Minimum 15 years of experience in Quality Assurance with experience in GxP Quality supporting pharmaceutical development, manufacturing, and testing
- Strong Project Management Skills
- Proven track record of critical thinking, flexibility, innovation, including the ability to manage priorities, track progress of key projects, and provide updates to leadership as required.
- Preferred experience with outsourced manufacturing and testing operations
- Preferred experience in working in compliance with US, EU and ICH GMP requirements, experience reviewing submission documentation, responses to regulatory inquiries and inspections
- Preferred experience with personalized medicines and nucleic acid-based and/or gene therapies
- Demonstrated ability to work independently, handle multiple tasks simultaneously, prioritize, negotiate and meet critical timelines.
- Strong interpersonal skills to effectively communicate with teams, peers, management and external contacts.
- Proven organizational and leadership skills to mentor and develop team to achieve Company goals. Demonstrated ability to effectively lead professional staff with at least 3 years experience.
- Working knowledge of MS Office products including Word, Excel, Outlook, PowerPoint, and Project.
- Must possess excellent organizational and communication skills.
- Thorough knowledge of preclinical, clinical and commercial product development. Post-market experience a plus. Technical knowledge of analytical method qualification, process validation and establishing product specifications.
- Rapid prioritization and decision-making for timely resolution of issues identified with the manufacturing or testing of clinical batches is essential, and decisions the individual may make are based on multiple sources of technical information that will require sound investigation and effective interpretation.
- The ability to negotiate and communicate in a positive manner, to discuss and address quality issues, anticipate globally the impact of known risks, and develop effective, pragmatic solutions is a requirement of the position.
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.
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.