Supplier Quality Lead - Drug Substance
Sanofi, a global healthcare leader, discovers, develops, and distributes therapeutic solutions focused on patients' needs. With 12 locations in Massachusetts, many located within close proximity to Boston, you'll have easy access to public transportation, popular restaurants, some of the best education, and most of all the history.
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HEALTH AND WELLNESS PROGRAMS
Comprehensive coverage including medical, dental, vision, and health and wellness programs.
Employer matching because Sanofi invests in their employees!
Sanofi is eager to further your development and expertise in an ever challenging environment.
Sanofi understands the importance of family. We offer a variety of support including maternity/paternity leave.
PAID TIME OFF
Enjoy 3 weeks’ vacation and paid holidays, including company shutdown at the end of every year!
Importance of life outside of the office is valued at Sanofi.
The Quality Lead provides quality oversight of cGMP activities act Contract Manufacturing Organizations (CMOs). This individual works within a cross functional team and is responsible for oversight of process performance qualification, technology transfers, PAI readiness, investigations, change controls, product disposition and ensuring compliance with Bioverativ Quality Management Systems and regulatory requirements, as needed. Role may require some travel both domestic and international.
- Provide quality oversight of cGMP external drug substance manufacturing operations
- Provide quality guidance and support for investigations and change controls
- Provide support of process performance qualification activities including document review and approval
- Provide support of product stability programs including document review and approval
- Perform review/approval of master production records, executed batch records and disposition of product
- Provide quality support for clinical and commercial technology transfers to CMOs
- Provide support of Bioverativ Quality Management Systems, as needed – e.g. product quality reviews, data compilation and analysis, audits, risk program
- Provide PAI readiness support including on-site support of CMOs, as needed
- Travel, as needed to CMOs to support Bioverativ products
- Participate in routine internal and external Operations Meetings
- Escalate quality and compliance issues to quality management
- Experience working with external partners (e.g. CMOs, contract laboratories and suppliers)
- Demonstrate strong leadership capabilities, but also the ability to actively listen
- Experience with biologics drug substance manufacturing processes
- Ability to influence in a matrix organization
- Understanding of and ability to apply pharmaceutical/biotech cGMP regulations and guidance using a risk-based approach
- Manage through ambiguity, work independently and prioritize the workload with minimal direction
- Exude a passion for relationship building both inside and outside the company
- Demonstrate excellent communication skills both internally and externally
- Ability to multi-task and work in a fast paced and dynamic environment
- Bachelor’s degree is required. Masters is preferred or equivalent combination of education, training, and experience that provides the individual with the required knowledge, skills, and abilities for this position.
- Minimum 8 years pharmaceutical / biotechnology industry experience. Demonstrated success in working cross-functionally in a matrix organization; minimum 4 years’ experience within a Quality role.
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.
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